Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 3:13 AM
Study NCT ID:
NCT07493369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Affect Treatment for Spanish-Speaking Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059445', 'term': 'Anhedonia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-07', 'size': 615576, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2026-03-20T11:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-20', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sheehan Disability Scale (SDS)', 'timeFrame': 'Screening', 'description': '3-item measure that assesses the severity of distress resulting from impairment in work, family life/home responsibilities, and social/leisure activities.'}, {'measure': 'Structured Clinical Interview for DSM-5 - Research Version (SCID-5-RV)', 'timeFrame': 'Screening and 1-month follow-up', 'description': "Structured clinical interview used to assess current (not past) clinical diagnoses. At a 1-month follow-up assessment, the study staff will conduct the SCID-5-RV without the exclusion criteria modules to describe the participants' clinical diagnoses after treatment."}, {'measure': 'Interviewer Anhedonia Ratings', 'timeFrame': 'Screening and 1-month follow-up', 'description': 'Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia'}, {'measure': 'Riverside Acculturation Stress Inventory', 'timeFrame': 'Pre-treatment (before session 1)', 'description': '12-item self-report questionnaire used to measure stress arising from adapting to a new culture'}, {'measure': 'Beck Scale for Suicide Ideation', 'timeFrame': 'Weekly from session 1-15', 'description': 'Item 9 of the Beck Depression Inventory-II (BDI-II) will be used to assess suicidality before each treatment session. The item is rated on a four-point scale from 0 to 3, with higher scores indicating greater severity.'}], 'primaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire-8 (CSQ-8)', 'timeFrame': 'Post-treatment (after session 15)', 'description': '8-item self-report measure used to capture satisfaction with services. Each item is scored on a four-point scale from 1 to 4, with a total score range from 8 to 32. Higher scores suggest greater satisfaction with the treatment.'}, {'measure': 'Working Alliance Inventory-Short (WAI-S)', 'timeFrame': 'Post-treatment (after session 15)', 'description': "12-item questionnaire used to assess the participants' therapeutic alliance ratings along three domains: goal, task, and bond."}, {'measure': 'Treatment Attrition', 'timeFrame': 'From enrollment to post-treatment (after session 15)', 'description': 'Treatment attrition will be calculated as the dropout percentage after enrollment.'}, {'measure': 'Treatment Attendance', 'timeFrame': 'From enrollment to post-treatment (after session 15)', 'description': 'Treatment attendance will be operationalized as the total number of treatment sessions attended out of the 15 planned sessions.'}, {'measure': 'Treatment Practice Adherence', 'timeFrame': 'From session 2 to post-treatment (after session 15)', 'description': "After each treatment session, the participant's practice completion (e.g., pleasant activities, savoring exercises) will be measured using a 0-100% scale, with 0% indicating that they did not complete any practice outside of therapy sessions, and 100% indicating that they completed all scheduled practice. Overall practice completion will be calculated as the average of practice outside of sessions completed across 14 sessions, since no homework will be assigned for the first session."}, {'measure': 'Credibility/Expectancy Questionnaire (CEQ)', 'timeFrame': 'After session 1', 'description': '6-item self-report measure, divided into credibility and outcome expectancy questions.'}, {'measure': 'Recruitment feasibility', 'timeFrame': 'From recruitment to enrollment', 'description': 'Feasibility of recruitment will be examined using three parameters: number of individuals screened per month, number of participants enrolled per month, and average time from screening to enrollment including the reason for any long delays. In addition, the reason for lack of enrollment (e.g., not eligible, not interested, lost to follow-up) will be recorded.'}, {'measure': 'Positive and Negative Affect Scale - Positive Subscale (PANAS-P)', 'timeFrame': 'Screening, weekly from session 1-15, and at 1-month follow-up', 'description': 'Self-report measure of positive affect. The scale includes 20 items, 10 indicating positive affect (e.g., excited) and 10 corresponding to negative affect (e.g., scared). Each item is rated on a five-point scale, with higher scores indicating a higher level of positive or negative affect.'}, {'measure': 'Depression Anxiety Stress Scale- 21 (DASS-21)', 'timeFrame': 'Screening, weekly from session 1-15 and at 1-month follow-up', 'description': '21-item self-report measure of symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.'}], 'secondaryOutcomes': [{'measure': 'Qualitative Feedback', 'timeFrame': 'Post-treatment (after session 15)', 'description': 'Participants will complete written open-ended items in Spanish asking about (1) treatment feasibility, (2) treatment acceptability, (3) treatment satisfaction, (4) treatment comprehension, (5) perceived effectiveness, (6) suggestions, and (7) other general comments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anhedonia', 'Depression in Adults', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the feasibility and acceptability of Positive Affect Treatment (PAT) in a Spanish-speaking population. PAT is a psychotherapy specifically aimed at enhancing reward sensitivity in individuals with low positive affect (a core feature of anhedonia) in the context of depression or anxiety.\n\nTarget enrollment is 12 participants with low positive affect and depression or anxiety and impaired functioning, between the ages of 18 and 65 years. Participants will complete psychiatric assessments and self-report questionnaires as part of the study.\n\nThe total length of participation is around 4 months.', 'detailedDescription': 'As an extension of two prior NIMH funded trials (R61 phase trial and R33 phase randomized controlled trial), the aim of this trial is to evaluate the feasibility and acceptability of PAT in a Spanish-speaking population with low positive affect in the context of depression, anxiety or stress symptoms.\n\nFeasibility, acceptability, and clinical outcomes are assessed at baseline and either weekly or at Week 15 (post) and one-month follow-up. Feasibility outcomes, such as session attendance, practice completion, and acceptability outcomes, such as satisfaction questionnaire, are assessed at Week 15 (post). Clinical outcomes are assessed at baseline and either weekly or at one-month follow-up.\n\nTarget enrollment is 12 participants with low positive affect and depression or anxiety and impaired functioning, between the ages of 18 and 65 years. Participants will complete psychiatric assessments and self-report questionnaires as part of the study.\n\nThe total length of participation is around 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spanish as their preferred language for therapy\n* Low positive affect indexed by less than or equal to 24 on the positive affect subscale of the PANAS (i.e., PANAS-P); and scores of greater than or equal to 11 for depression, greater to or equal to 6 for anxiety, or greater to or equal to 10 for stress on the Depression, Anxiety, and Stress Scale; and scores of greater than or equal to 5 on any Sheehan Disability Scale subscale.\n* Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion\n\nExclusion Criteria:\n\n* Patient report of serious medical conditions - such as history of serious, uncontrolled medical illness, or instability (including significant cardio-pulmonary disease, organic brain syndrome, seizure disorder, cerebrovascular disease, thyroid dysfunction, and diabetes)\n* Active suicidal ideation\n* Lifetime history of bipolar disorder, psychosis, cognitive impairment, or organic brain damage\n* Substance abuse in the last 6 months or dependence within last 12 months.\n* Greater than 11 cigarettes per week or nicotine equivalent before age 15\n* History of marijuana, cocaine or stimulant use 5-7 times/week or more before age 15 (e.g., amphetamine, cocaine, methamphetamine)\n* Pregnancy\n* Bupropion, dopaminergic or neuroleptic medications use in the past 6 months\n* Refusal of video/audio-taping\n* Prior participation in previous waves of this study'}, 'identificationModule': {'nctId': 'NCT07493369', 'briefTitle': 'Positive Affect Treatment for Spanish-Speaking Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Southern Methodist University'}, 'officialTitle': 'Positive Affect Treatment for Spanish-speaking Individuals With Depression and Anxiety: An Uncontrolled Pilot Trial', 'orgStudyIdInfo': {'id': '25-093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Positive Affect Treatment', 'description': '15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.', 'interventionNames': ['Behavioral: Positive Affect Treatment']}], 'interventions': [{'name': 'Positive Affect Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['PAT'], 'description': 'Sessions 1-7: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects (continued for sessions 8-15) Sessions 8-10: Cognitive exercises focusing on identifying positive aspects of experience, taking responsibility for positive outcomes, and imagining future positive events Sessions 11-14: Exercises to cultivate and savor positive experiences Session 15: Relapse prevention', 'armGroupLabels': ['Positive Affect Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75205', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southern Methodist University', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Alicia E Meuret, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Methodist University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Methodist University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychology Graduate Student', 'investigatorFullName': 'Sofia Uribe', 'investigatorAffiliation': 'Southern Methodist University'}}}}