Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-02-13 @ 11:48 AM
Study NCT ID:
NCT02754557
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2016-04-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physiological Augmentation of Mindfulness Meditation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nfani@emory.edu', 'phone': '404-712-0354', 'title': 'Negar Fani, PhD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected beginning at the baseline assessment and continued through the One Month Post-treatment visit (up to 8 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Multiscale Dissociation Inventory (MDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation'}, {'id': 'OG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.19', 'spread': '12.99', 'groupId': 'OG000'}, {'value': '61.58', 'spread': '20.00', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.15', 'spread': '15.13', 'groupId': 'OG000'}, {'value': '51.00', 'spread': '15.53', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-Treatment (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.11', 'spread': '14.44', 'groupId': 'OG000'}, {'value': '47.94', 'spread': '17.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The MDI is a 30-item self-report test of dissociative symptomology and it measures six different types of dissociative response. The scales of the MDI are disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, identity dissociation, and total dissociation. Items are scored from 1 to 5 where 1 = never and 5 = very often. Total scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who attended the indicated study visit. One participant in the Breath-Focused Meditation Plus Physiological Feedback group attended the one month post-treatment visit but did not complete the MDI.'}, {'type': 'PRIMARY', 'title': 'Modified PTSD Symptom Scale (MPSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation'}, {'id': 'OG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.33', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '28.82', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.63', 'spread': '10.54', 'groupId': 'OG000'}, {'value': '20.97', 'spread': '12.27', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-treatment (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.58', 'spread': '10.52', 'groupId': 'OG000'}, {'value': '19.44', 'spread': '12.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The MPSS is an 18-item instrument assessing the presence and severity of PTSD symptoms related to specific traumatic events in individuals with a known trauma history. Respondents indicate how frequently they experience each item on a scale of 0 to 3 where 0 = not at all and 3 = almost always. PTSD symptomatology over the prior 2 weeks is assessed, yielding a continuous measure of PTSD symptom severity ranging from 0 to 54. A higher score indicates greater symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who attended the indicated study visit.'}, {'type': 'PRIMARY', 'title': 'Kentucky Mindfulness Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation'}, {'id': 'OG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.19', 'spread': '17.68', 'groupId': 'OG000'}, {'value': '117.55', 'spread': '19.24', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125.37', 'spread': '20.25', 'groupId': 'OG000'}, {'value': '125.79', 'spread': '17.29', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-treatment (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.58', 'spread': '22.25', 'groupId': 'OG000'}, {'value': '126.65', 'spread': '16.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The Kentucky Mindfulness Scale is a 39-item scale that assesses skills related to what one does while practicing mindfulness. Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. Total scores range from 39 to 195 and higher scores reflect more mindfulness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who attended the indicated study visit. One participant in the Breath-Focused Meditation Plus Physiological Feedback group attended the one month post-treatment visit but did not complete the Kentucky Mindfulness Scale.'}, {'type': 'PRIMARY', 'title': 'Multidimensional Assessment of Interoceptive Awareness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation'}, {'id': 'OG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.22', 'spread': '24.39', 'groupId': 'OG000'}, {'value': '86.45', 'spread': '25.03', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment (Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '107.37', 'spread': '31.46', 'groupId': 'OG000'}, {'value': '106.92', 'spread': '24.94', 'groupId': 'OG001'}]}]}, {'title': 'One Month Post-treatment (Week 8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.63', 'spread': '28.29', 'groupId': 'OG000'}, {'value': '105.29', 'spread': '27.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'This is a clinical measure that assesses various aspects of interoception, including ability to attend to body sensations, regulate distress by attending to body sensations, and experiencing body sensations as safe and trustworthy. The instrument includes 32 items and which are scored from 0 to 5, where 0 = never and 5 = always. Total scores range from 0 to 160 and higher scores indicate greater awareness of body sensations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who attended the indicated study visit. One participant in the Breath-Focused Meditation Plus Physiological Feedback group attended the one month post-treatment visit but did not complete the Multidimensional Assessment of Interoceptive Awareness assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Clinician Administered PTSD Scale (CAPS) Score', 'timeFrame': 'Baseline', 'description': 'The CAPS is a 30-item structured interview that can be used to make current and lifetime diagnosis of post traumatic stress disorder (PTSD) as well as assess PTSD symptoms over the past week. Questions also examine the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The identification of an index traumatic event to serves as the basis for symptom inquiry. The full interview takes approximately 45-60 minutes to administer. Items are scored from 0 to 4 where 0 = the symptom is absent and 4 = the symptom is incapacitating. A symptom severity score is obtained by summing items 1-20. Total scores range from 0 to 80 and a higher score indicates more severe PTSD symptoms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mini International Neuropsychiatric Interview (MINI) Score', 'timeFrame': 'Baseline', 'description': 'Mini International Neuropsychiatric Interview is a semistructured interview that will be used to assess for concurrent mood, substance, and psychotic disorders. The interview takes 30 minutes - 1 hour to administer. Participants answer "yes" or "no" to questions about symptoms they have been having; from these responses a clinician can diagnose lifetime and/or current presence of 22 psychiatric conditions. The number of instrument items used per interview depends on responses to previous questions and the interview is not designed to provide a numeric total score.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Kreek-McHugh-Schluger-Kellogg (KMSK) Marijuana/Cannabis Scale Score', 'timeFrame': 'Baseline', 'description': 'This is a clinical measure designed to quickly assess the nature and extent of recreational use of cannabis during the last 24 hours. The instrument includes a 15-item scale where respondents indicate how much the agree with reasons for using marijuana, where 0 = strongly disagree and 5 = strongly agree. The full measure will be administered at the beginning of study participation, and one question about drug use in the past day (if applicable) will be administered on study intervention days.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Affective Number Stroop (ANS) Task Score', 'timeFrame': 'Up to Week 4', 'description': 'During the Affective Number Stroop (ANS) Task, participants are instructed to rapidly identify the number of numbers in a given display while ignoring evocative distractor images (trauma-relevant scenes) while in a MRI scanner. In these trials, the number of numbers presented is either consistent or inconsistent with the actual number displayed, such that there are both congruent and incongruent trials. The participants will be presented with positive and neutral pictures in addition to the negative trauma-relevant images. The task will be completed in the MRI scanner during both the pre- and post-treatment sessions.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Penn Computerized Neuropsychological Battery Performance', 'timeFrame': 'Up to Week 4', 'description': 'This is a computerized neuropsychological assessment that is designed to examine different domains of cognitive functioning. The executive functioning and memory components of this battery will be administered, which take approximately 30 minutes to complete.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Posttraumatic Avoidance Behaviour Questionnaire (PABQ) Score', 'timeFrame': 'Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': "The PABQ includes 25 items asking participants how often they engaged in certain behaviors in the past 3 weeks. Responses are given on a 4-point scale where 1 = almost never and 4 = almost always. Total scores range from 25 to 100 and higher scores indicate greater avoidance. This questionnaire will be given at post-treatment and follow-up time points to capture participants' avoidance behaviors during this time.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change in Chesney's Coping Self-Efficacy Scale (CSES) Score", 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': "The CSES is a 26-item scale that measures one's perceived ability to cope with life's difficulties. Responses are given on a scale from 0 to 10 where 0 = cannot do at all and 10 = certain can do. Total scores range from 0 to 260 where higher scores indicate greater self-efficacy with coping skills.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in State Self Efficacy Scale Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'This is a 7 Item measure using a 7-point likert scale that will examine changes over time in self-efficacy on a state level. Responses to items range from 1 = strongly disagree to 7 = strongly agree. Total scores range from 1 to 49 where higher scores indicate greater self-efficacy.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Moral Injury Events Scale for Civilians (MIES-C) Score', 'timeFrame': 'Baseline', 'description': 'The Moral Injury Events Scale for Civilians (MIES-C) measurement is a 10-item scale assessing for the presence of potentially morally injurious events and feelings of distress that can emerge in the aftermath of these events. Responses are given on a 6-point scale where 1 = strongly agree and 6 = strongly disagree. Total scores range from 10 to 60 and lower scores indicate more exposure to events that conflict with the respondents sense of right and wrong.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Attentional Control Scale (ACS) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'This is a 20-item self-report measure that assesses attentional control a 4-point Likert scale, where 1 = almost never and 4 = always. Total scores range from 20 to 80 and higher scores indicate greater difficulty with attentional control.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in State Trait Anxiety Inventory (STAI) Score', 'timeFrame': 'Baseline up to Week 4 (post-treatment)', 'description': 'The STAI is a 40-item self-report measure that uses a 4-point Likert scale to evaluate both state and trait anxiety. Total scores range from 40 to 160 and items are scored so that a higher total score indicates greater symptoms of anxiety. This is administered at the pre-MRI and post-MRI data collection points for every MRI visit.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Visual Analogue Scale (VAS) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment)', 'description': 'This is a 6-item self-report measure that indicates how intense one is feeling certain emotions using a 10-point Likert scale. Total scores range from 0 to 60 with higher scores indicating greater intensity of emotions.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Motivation and Pleasure -Self Report (MAP-SR) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The MAP-SR is an 18-item self-report measure that assesses the motivation and pleasure domain of negative symptoms. Items are rated on a 5-point Likert scale and total scores range from 0 to 72. Certain items are reverse scored so that lower scores indicate greater pathology.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in State Mindfulness Scale (SMS) Score', 'timeFrame': 'Pre-intervention and post-intervention of each session up to Week 4', 'description': "This is a 21-item self-report measure that uses a 5-point Likert scale to assess one's perceived level of awareness and attention to the present moment and environment within a given frame of time (i.e. the last 10 minutes). This is administered before and after each intervention session. Responses are given on a scale from 1 (not at all) to 5 (very well). Total scores range from 21 to 105 and higher scores indicate greater mindfulness.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': 'Week 4 (post-treatment)', 'description': "The CSQ is an 11-item self-report measure to assess how the intervention satisfied the participant's expectations and/or if it helped their daily lives in any way. The questionnaire contains a mix of scaled responses and open ended questions and there is not a summary score for this measurement.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation'}, {'id': 'FG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Completed Post-treatment Assessment at Week 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Completed One-month Post-treatment Assessment at Week 8', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'comment': 'Completed the primary aim of the study which was the post-treatment follow up assessment at Week 4.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from Grady Memorial Hospital and the Wesley Woods Center in Atlanta, Georgia, USA. Participant enrollment began in March 2016 and the one month follow-up assessments were completed by September 21, 2021.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation'}, {'id': 'BG001', 'title': 'Breath-Focused Meditation Plus Physiological Feedback', 'description': 'Women with post traumatic stress disorder receiving breath-focused meditation augmented with physiological feedback'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.48', 'spread': '11.97', 'groupId': 'BG000'}, {'value': '40.11', 'spread': '12.22', 'groupId': 'BG001'}, {'value': '42.38', 'spread': '12.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-29', 'size': 295652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-13T15:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-20', 'studyFirstSubmitDate': '2016-04-06', 'resultsFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2016-04-25', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-20', 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Clinician Administered PTSD Scale (CAPS) Score', 'timeFrame': 'Baseline', 'description': 'The CAPS is a 30-item structured interview that can be used to make current and lifetime diagnosis of post traumatic stress disorder (PTSD) as well as assess PTSD symptoms over the past week. Questions also examine the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The identification of an index traumatic event to serves as the basis for symptom inquiry. The full interview takes approximately 45-60 minutes to administer. Items are scored from 0 to 4 where 0 = the symptom is absent and 4 = the symptom is incapacitating. A symptom severity score is obtained by summing items 1-20. Total scores range from 0 to 80 and a higher score indicates more severe PTSD symptoms.'}, {'measure': 'Change in Mini International Neuropsychiatric Interview (MINI) Score', 'timeFrame': 'Baseline', 'description': 'Mini International Neuropsychiatric Interview is a semistructured interview that will be used to assess for concurrent mood, substance, and psychotic disorders. The interview takes 30 minutes - 1 hour to administer. Participants answer "yes" or "no" to questions about symptoms they have been having; from these responses a clinician can diagnose lifetime and/or current presence of 22 psychiatric conditions. The number of instrument items used per interview depends on responses to previous questions and the interview is not designed to provide a numeric total score.'}, {'measure': 'Change in Kreek-McHugh-Schluger-Kellogg (KMSK) Marijuana/Cannabis Scale Score', 'timeFrame': 'Baseline', 'description': 'This is a clinical measure designed to quickly assess the nature and extent of recreational use of cannabis during the last 24 hours. The instrument includes a 15-item scale where respondents indicate how much the agree with reasons for using marijuana, where 0 = strongly disagree and 5 = strongly agree. The full measure will be administered at the beginning of study participation, and one question about drug use in the past day (if applicable) will be administered on study intervention days.'}, {'measure': 'Change in Affective Number Stroop (ANS) Task Score', 'timeFrame': 'Up to Week 4', 'description': 'During the Affective Number Stroop (ANS) Task, participants are instructed to rapidly identify the number of numbers in a given display while ignoring evocative distractor images (trauma-relevant scenes) while in a MRI scanner. In these trials, the number of numbers presented is either consistent or inconsistent with the actual number displayed, such that there are both congruent and incongruent trials. The participants will be presented with positive and neutral pictures in addition to the negative trauma-relevant images. The task will be completed in the MRI scanner during both the pre- and post-treatment sessions.'}, {'measure': 'Change in Penn Computerized Neuropsychological Battery Performance', 'timeFrame': 'Up to Week 4', 'description': 'This is a computerized neuropsychological assessment that is designed to examine different domains of cognitive functioning. The executive functioning and memory components of this battery will be administered, which take approximately 30 minutes to complete.'}, {'measure': 'Change in Posttraumatic Avoidance Behaviour Questionnaire (PABQ) Score', 'timeFrame': 'Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': "The PABQ includes 25 items asking participants how often they engaged in certain behaviors in the past 3 weeks. Responses are given on a 4-point scale where 1 = almost never and 4 = almost always. Total scores range from 25 to 100 and higher scores indicate greater avoidance. This questionnaire will be given at post-treatment and follow-up time points to capture participants' avoidance behaviors during this time."}, {'measure': "Change in Chesney's Coping Self-Efficacy Scale (CSES) Score", 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': "The CSES is a 26-item scale that measures one's perceived ability to cope with life's difficulties. Responses are given on a scale from 0 to 10 where 0 = cannot do at all and 10 = certain can do. Total scores range from 0 to 260 where higher scores indicate greater self-efficacy with coping skills."}, {'measure': 'Change in State Self Efficacy Scale Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'This is a 7 Item measure using a 7-point likert scale that will examine changes over time in self-efficacy on a state level. Responses to items range from 1 = strongly disagree to 7 = strongly agree. Total scores range from 1 to 49 where higher scores indicate greater self-efficacy.'}, {'measure': 'Change in Moral Injury Events Scale for Civilians (MIES-C) Score', 'timeFrame': 'Baseline', 'description': 'The Moral Injury Events Scale for Civilians (MIES-C) measurement is a 10-item scale assessing for the presence of potentially morally injurious events and feelings of distress that can emerge in the aftermath of these events. Responses are given on a 6-point scale where 1 = strongly agree and 6 = strongly disagree. Total scores range from 10 to 60 and lower scores indicate more exposure to events that conflict with the respondents sense of right and wrong.'}, {'measure': 'Change in Attentional Control Scale (ACS) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'This is a 20-item self-report measure that assesses attentional control a 4-point Likert scale, where 1 = almost never and 4 = always. Total scores range from 20 to 80 and higher scores indicate greater difficulty with attentional control.'}, {'measure': 'Change in Difficulties in Emotion Regulation Scale (DERS)', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The DERS is a 36 item instrument that measures emotional dysregulation symptoms. Responses are given on a 5-point scale where 1 = almost never and 5 = almost always. The DERS scales include 1) nonacceptance of emotional responses, 2) difficulty engaging in goal-directed behavior, 3) difficulties with impulse control, 4) limited emotional awareness, 5) limited access to emotion regulation strategies, and 6) lack of emotional clarity. Total scores range from 36 to 180 and higher scores suggest greater problems with emotion regulation.'}, {'measure': 'Change in State Trait Anxiety Inventory (STAI) Score', 'timeFrame': 'Baseline up to Week 4 (post-treatment)', 'description': 'The STAI is a 40-item self-report measure that uses a 4-point Likert scale to evaluate both state and trait anxiety. Total scores range from 40 to 160 and items are scored so that a higher total score indicates greater symptoms of anxiety. This is administered at the pre-MRI and post-MRI data collection points for every MRI visit.'}, {'measure': 'Change in Visual Analogue Scale (VAS) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment)', 'description': 'This is a 6-item self-report measure that indicates how intense one is feeling certain emotions using a 10-point Likert scale. Total scores range from 0 to 60 with higher scores indicating greater intensity of emotions.'}, {'measure': 'Change in Motivation and Pleasure -Self Report (MAP-SR) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The MAP-SR is an 18-item self-report measure that assesses the motivation and pleasure domain of negative symptoms. Items are rated on a 5-point Likert scale and total scores range from 0 to 72. Certain items are reverse scored so that lower scores indicate greater pathology.'}, {'measure': 'Change in State Mindfulness Scale (SMS) Score', 'timeFrame': 'Pre-intervention and post-intervention of each session up to Week 4', 'description': "This is a 21-item self-report measure that uses a 5-point Likert scale to assess one's perceived level of awareness and attention to the present moment and environment within a given frame of time (i.e. the last 10 minutes). This is administered before and after each intervention session. Responses are given on a scale from 1 (not at all) to 5 (very well). Total scores range from 21 to 105 and higher scores indicate greater mindfulness."}, {'measure': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': 'Week 4 (post-treatment)', 'description': "The CSQ is an 11-item self-report measure to assess how the intervention satisfied the participant's expectations and/or if it helped their daily lives in any way. The questionnaire contains a mix of scaled responses and open ended questions and there is not a summary score for this measurement."}], 'primaryOutcomes': [{'measure': 'Multiscale Dissociation Inventory (MDI) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The MDI is a 30-item self-report test of dissociative symptomology and it measures six different types of dissociative response. The scales of the MDI are disengagement, depersonalization, derealization, emotional constriction/numbing, memory disturbance, identity dissociation, and total dissociation. Items are scored from 1 to 5 where 1 = never and 5 = very often. Total scores range from 30 to 150 where higher scores indicate greater symptoms of dissociation.'}, {'measure': 'Modified PTSD Symptom Scale (MPSS) Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The MPSS is an 18-item instrument assessing the presence and severity of PTSD symptoms related to specific traumatic events in individuals with a known trauma history. Respondents indicate how frequently they experience each item on a scale of 0 to 3 where 0 = not at all and 3 = almost always. PTSD symptomatology over the prior 2 weeks is assessed, yielding a continuous measure of PTSD symptom severity ranging from 0 to 54. A higher score indicates greater symptom severity.'}, {'measure': 'Kentucky Mindfulness Scale Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'The Kentucky Mindfulness Scale is a 39-item scale that assesses skills related to what one does while practicing mindfulness. Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. Total scores range from 39 to 195 and higher scores reflect more mindfulness.'}, {'measure': 'Multidimensional Assessment of Interoceptive Awareness Score', 'timeFrame': 'Baseline, Week 4 (post-treatment), Week 8 (one month post-treatment)', 'description': 'This is a clinical measure that assesses various aspects of interoception, including ability to attend to body sensations, regulate distress by attending to body sensations, and experiencing body sensations as safe and trustworthy. The instrument includes 32 items and which are scored from 0 to 5, where 0 = never and 5 = always. Total scores range from 0 to 160 and higher scores indicate greater awareness of body sensations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Trauma', 'PTSD', 'Mindfulness', 'Meditation', 'Neuroimaging', 'MRI'], 'conditions': ['Post Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '34603539', 'type': 'DERIVED', 'citation': 'Powers A, Dixon HD, Guelfo A, Mekawi Y, Bradley B, Kaslow N, Fani N. The mediating role of emotion dysregulation in the association between trait mindfulness and PTSD symptoms among trauma-exposed adults. Mindfulness (N Y). 2021 Sep;12(9):2229-2240. doi: 10.1007/s12671-021-01684-8. Epub 2021 Jul 16.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to compare the efficacy of a physiologically-augmented breath-focused mindfulness-based intervention to reduce symptoms of dissociation that are associated with psychological trauma, as well as symptoms of posttraumatic stress disorder (PTSD). The study will evaluate whether physiological augmentation produces a greater change in dissociative symptoms, meditative engagement and attentional control, compared to non-augmented mindfulness. The augmentation comprises physiological feedback in the form of a vibration on the wrist. Vibrations are delivered by a device that will be placed on a participant's arm; the device vibrates in proportion to the person's breath.", 'detailedDescription': 'Chronically traumatized people are at much higher risk for developing dissociative symptoms, which are notoriously difficult to treat, particularly in the context of other posttraumatic stress disorder symptoms. Dissociation is a phenomenon that involves feelings of separation from one\'s body and emotional state. Mindfulness practices, including breath-focused mindfulness meditation, are known to be useful for improving attention to one\'s physiological state, thus enhancing a feeling of "connection" with one\'s present experience. However, mindfulness-based practices are naturally a challenging task for highly dissociative people. The present project proposes the use of a novel device that uses physiological feedback to boost the effects of breath-focused mindfulness meditation in this population. This device is an element placed on the wrist that vibrates in accordance with one\'s breath. The method capitalizes on a "bottom-up" neurophysiological process. This study plans to recruit 80 highly dissociative traumatized African American women through an established and highly productive NIH-funded project. Participants will be randomly assigned to 6 sessions of either breath-focused mindfulness meditation or physiologically augmented breath-focused mindfulness meditation. Electroencephalography data will be collected during the intervention sessions, and functional magnetic resonance imaging data will be collected pre- and post-intervention. These methods will be used to assess whether the physiological augmentation is producing: increased coherence or "network-like" activity among brain regions involved with interoception (awareness of one\'s bodily state); selective attention to the breath (increased temporo-parietal EEG gamma) and meditative engagement (increased frontal EEG theta). Clinical and neuropsychological measures will be used to assess potential effects on dissociative and posttraumatic symptoms, as well as selective and sustained attention and mindfulness ability. A follow-up will be conducted 1 month post-treatment to examine sustained clinical and cognitive effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experience of at least one Criterion A trauma\n* Presence of current symptoms of post traumatic stress disorder (PTSD) that are significantly interfering with functioning\n* Multiscale Dissociation Inventory depersonalization score of 7\n* Fulfill at least two of the Clinician Administered PTSD Subscale criteria of clinically significant re-experiencing, avoidance, alterations in mood and cognitions, hyperarousal\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Actively psychotic\n* Cognitively compromised\n* Pregnancy\n* Substance or Alcohol Dependence'}, 'identificationModule': {'nctId': 'NCT02754557', 'acronym': 'PAMM', 'briefTitle': 'Physiological Augmentation of Mindfulness Meditation', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Physiological Augmentation of Mindfulness Meditation', 'orgStudyIdInfo': {'id': 'IRB00085711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breath-Focused Meditation', 'description': 'Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation.', 'interventionNames': ['Other: Breath-Focused Meditation']}, {'type': 'EXPERIMENTAL', 'label': 'Breath-Focused Meditation + Physiological Feedback', 'description': 'Women with post traumatic stress disorder (PTSD) will receive breath-focused meditation and physiological feedback.', 'interventionNames': ['Other: Breath-Focused Meditation', 'Device: Physiological Feedback']}], 'interventions': [{'name': 'Breath-Focused Meditation', 'type': 'OTHER', 'description': 'Participants will attend two breath-focused meditation sessions per week for three weeks. During the breath focus task, participants are asked to alternatively focus their breathing (1.5 minutes of breathing and 15 seconds of rest). Participants will be asked to "attend to the changing patterns of physical sensations as the breath moves in and out of your body. Focus your awareness on any sensations you may experience (e.g., your abdominal wall rising). Follow the sensations as you breathe in and all the way through until your breath leaves your body".', 'armGroupLabels': ['Breath-Focused Meditation', 'Breath-Focused Meditation + Physiological Feedback']}, {'name': 'Physiological Feedback', 'type': 'DEVICE', 'description': 'Participants will receive breath feedback, via dynamic velocity estimates from a respiration belt, which allows an analog of breath to be felt as vibration on their wrist via a tactile transducer on a table. The transducer is tuned to produce low frequencies so there is more vibration and less of an audible component than a regular speaker would produce.', 'armGroupLabels': ['Breath-Focused Meditation + Physiological Feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Health System', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wesley Woods Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Negar Fani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Negar Fani', 'investigatorAffiliation': 'Emory University'}}}}