Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 5:49 PM
Study NCT ID:
NCT00760994
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2008-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D000088686', 'term': 'Cognitive Restructuring'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D018673', 'term': 'Nutrition Policy'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D006291', 'term': 'Health Policy'}, {'id': 'D011640', 'term': 'Public Policy'}, {'id': 'D011049', 'term': 'Social Control Policies'}, {'id': 'D057766', 'term': 'Policy'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tracy.simpson@va.gov', 'phone': '206-277-3337', 'title': 'Tracy Simpson, Ph.D.', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations of the present study:\n\n1\\. The study had a short follow-up assessment period (5 weeks) \\& did not assess all PTSD symptoms.\n\n3\\. Asking participants to recall \\& report drinking on a daily basis may have enhanced the impacts of interventions.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected on the average of 44 days/participant, with a range of 42 to 71 days. Our first participant joined the study in May 2009 and the last participant completed the study in December 2010 (1 year and 7 months).', 'description': 'We did not systematically collect adverse events, but participants had opportunities to report adverse events throughout follow-up calls and in-person visits.', 'eventGroups': [{'id': 'EG000', 'title': '1 - Experiential Accepatance (EA)', 'description': "Experiential acceptance\n\nExperiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert \\& Forsyth, 2005; Hayes, Strosahl, \\& Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, \\& Barlow, 2004).", 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 - Cognitive Restructuring (CR)', 'description': "Cognitive restructuring\n\nCognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992).", 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 - Control', 'description': 'No-intervention control: Nutrition information\n\nNo-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Experiential Accepatance', 'description': "Experiential acceptance\n\nExperiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert \\& Forsyth, 2005; Hayes, Strosahl, \\& Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, \\& Barlow, 2004)."}, {'id': 'OG001', 'title': '2 - Cognitive Restructuring', 'description': "Cognitive restructuring\n\nCognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."}, {'id': 'OG002', 'title': '3 - Control', 'description': 'No-intervention control: Nutrition information\n\nNo-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks', 'description': "After the treatment had been started and for five weeks following the treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited.", 'unitOfMeasure': 'drinks per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed using Generalized Estimating Equation (GEE) models.'}, {'type': 'SECONDARY', 'title': 'Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 - Experiential Accepatance (EA)', 'description': "Experiential acceptance\n\nExperiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert \\& Forsyth, 2005; Hayes, Strosahl, \\& Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, \\& Barlow, 2004)."}, {'id': 'OG001', 'title': '2 - Cognitive Restructuring (CR)', 'description': "Cognitive restructuring\n\nCognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."}, {'id': 'OG002', 'title': '3 - Control', 'description': 'No-intervention control: Nutrition information\n\nNo-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks', 'description': "PTSD scores were collected via the IVR technology after the treatment has been started and for the next five weeks. Participants completed an abbreviated version of PCL-C (PTSD Checklist-Civilian Version) daily. Three re-experiencing symptoms, 2 avoidance symptoms, 3 emotional numbing symptoms, \\& 4 four hyperarousal symptoms were included. Participants rated each symptom from 0 (not at all) to 8 (all the time). The higher the score, the more intense their PTSD symptoms. The minimum \\& maximum possible scores were 0 \\& 96, respectively. Each participant's data were added and averaged to get the average PTSD scores per day of each treatment group (EA and CR) and control group.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed using Generalized Estimating Equation (GEE) models.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 - Experiential Accepatance (EA)', 'description': "Experiential acceptance\n\nExperiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert \\& Forsyth, 2005; Hayes, Strosahl, \\& Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, \\& Barlow, 2004)."}, {'id': 'FG001', 'title': '2 - Cognitive Restructuring (CR)', 'description': "Cognitive restructuring\n\nCognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."}, {'id': 'FG002', 'title': '3 - Control', 'description': 'No-intervention control: Nutrition information\n\nNo-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participant who wanted to decrease their alcohol use were recruited through newspaper advertisements \\& flyers. One hundred thirty two individuals were consented, 92 out of the 132 consented individuals were eligible, and 80 were randomized. Seventy eight participants received an intervention.', 'preAssignmentDetails': "Out of 132 individuals who provided written consent, 40 were ineligible:\n\n1. 10 individuals didn't use alcohol or have an alcohol diagnosis.\n2. 16 individuals didn't have PTSD.\n3. 4 individuals used an opiate or methamphetamine.\n4. 7 individuals had a bipolar disorder or psychotic.\n5. 3 individuals had reasons other than the ones above."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1 - Experiential Accepatance (EA)', 'description': "Experiential acceptance\n\nExperiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert \\& Forsyth, 2005; Hayes, Strosahl, \\& Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, \\& Barlow, 2004)."}, {'id': 'BG001', 'title': '2 - Cognitive Restructuring (CR)', 'description': "Cognitive restructuring\n\nCognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992)."}, {'id': 'BG002', 'title': '3 - Control', 'description': 'No-intervention control: Nutrition information\n\nNo-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.93', 'spread': '12.34', 'groupId': 'BG000'}, {'value': '42.97', 'spread': '12.44', 'groupId': 'BG001'}, {'value': '46.95', 'spread': '8.75', 'groupId': 'BG002'}, {'value': '44.32', 'spread': '11.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'White (non Hispanic)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'Multiple race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average Drinks per Day Assessed Using Daily Interactive Voice Response (IVR)', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '4.0', 'spread': '4.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "One week prior to treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the baseline average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited.", 'unitOfMeasure': 'drinks per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average PTSD Scores per Day Assessed Using Daily Interactive Voice Response (IVR)', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '4.0', 'spread': '1.4', 'groupId': 'BG002'}, {'value': '3.7', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "One week prior to treatment, participants completed an abbreviated version of PCL-C (PTSD Checklist-Civilian Version) daily via the IVR technology. Three re-experiencing symptoms, 2 avoidance symptoms, 3 emotional numbing symptoms, \\& 4 four hyperarousal symptoms were included. Participants rated each symptom from 0 (not at all) to 8 (all the time). The higher the score, the more intense their PTSD symptoms. The minimum \\& maximum possible scores were 0 \\& 96, respectively. Each participant's data were added and averaged to get the average baseline PTSD scores per day for each group.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "Two of the 29 participants in the Experiential Acceptance group didn't receive the intervention, thus their data weren't included in the baseline and outcome analyses."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-12-09', 'size': 1116408, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-11T20:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2008-09-25', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-27', 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)', 'timeFrame': '5 weeks', 'description': "After the treatment had been started and for five weeks following the treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited."}], 'secondaryOutcomes': [{'measure': 'Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)', 'timeFrame': '5 weeks', 'description': "PTSD scores were collected via the IVR technology after the treatment has been started and for the next five weeks. Participants completed an abbreviated version of PCL-C (PTSD Checklist-Civilian Version) daily. Three re-experiencing symptoms, 2 avoidance symptoms, 3 emotional numbing symptoms, \\& 4 four hyperarousal symptoms were included. Participants rated each symptom from 0 (not at all) to 8 (all the time). The higher the score, the more intense their PTSD symptoms. The minimum \\& maximum possible scores were 0 \\& 96, respectively. Each participant's data were added and averaged to get the average PTSD scores per day of each treatment group (EA and CR) and control group."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alcohol', 'Alcoholic', 'Alcoholism', 'Post-traumatic stress disorder', 'PTSD', 'Experiential acceptance', 'Mindfulness', 'Meditation', 'Meditate', 'Cognitive restructuring', 'Cognitive', 'Behavioral', 'Therapy', 'Treatment', 'Study', 'Intervention'], 'conditions': ['Alcoholism', 'Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '2343787', 'type': 'BACKGROUND', 'citation': 'Litt MD, Cooney NL, Kadden RM, Gaupp L. Reactivity to alcohol cues and induced moods in alcoholics. Addict Behav. 1990;15(2):137-46. doi: 10.1016/0306-4603(90)90017-r.'}, {'pmid': '3527003', 'type': 'BACKGROUND', 'citation': 'Brownell KD, Marlatt GA, Lichtenstein E, Wilson GT. Understanding and preventing relapse. Am Psychol. 1986 Jul;41(7):765-82. doi: 10.1037//0003-066x.41.7.765. No abstract available.'}, {'pmid': '9131844', 'type': 'BACKGROUND', 'citation': 'Cooney NL, Litt MD, Morse PA, Bauer LO, Gaupp L. Alcohol cue reactivity, negative-mood reactivity, and relapse in treated alcoholic men. J Abnorm Psychol. 1997 May;106(2):243-50. doi: 10.1037//0021-843x.106.2.243.'}, {'pmid': '11772473', 'type': 'BACKGROUND', 'citation': 'Coffey SF, Saladin ME, Drobes DJ, Brady KT, Dansky BS, Kilpatrick DG. Trauma and substance cue reactivity in individuals with comorbid posttraumatic stress disorder and cocaine or alcohol dependence. Drug Alcohol Depend. 2002 Jan 1;65(2):115-27. doi: 10.1016/s0376-8716(01)00157-0.'}, {'pmid': '7473043', 'type': 'BACKGROUND', 'citation': 'Cooper ML, Frone MR, Russell M, Mudar P. Drinking to regulate positive and negative emotions: a motivational model of alcohol use. 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JAMA. 1990 Nov 21;264(19):2511-8.'}, {'pmid': '7934057', 'type': 'BACKGROUND', 'citation': 'Rubonis AV, Colby SM, Monti PM, Rohsenow DJ, Gulliver SB, Sirota AD. Alcohol cue reactivity and mood induction in male and female alcoholics. J Stud Alcohol. 1994 Jul;55(4):487-94. doi: 10.15288/jsa.1994.55.487.'}, {'pmid': '12625430', 'type': 'BACKGROUND', 'citation': 'Simpson TL. Childhood sexual abuse, PTSD, and the functional roles of alcohol use among women drinkers. Subst Use Misuse. 2003 Jan;38(2):249-70. doi: 10.1081/ja-120017248.'}, {'pmid': '15530716', 'type': 'BACKGROUND', 'citation': 'Tate SR, Brown SA, Unrod M, Ramo DE. Context of relapse for substance-dependent adults with and without comorbid psychiatric disorders. Addict Behav. 2004 Dec;29(9):1707-24. doi: 10.1016/j.addbeh.2004.03.037.'}, {'type': 'BACKGROUND', 'citation': "Eifert, G.H., & Forsyth, J.P. (2005) Acceptance & commitment therapy for anxiety disorders: A practitioner's treatment guide to using mindfulness, acceptance, and values-based behavior change strategies. Oakland, CA: New Harbinger Publications."}, {'type': 'BACKGROUND', 'citation': 'Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change. New York: Guilford Press.'}, {'type': 'BACKGROUND', 'citation': 'Kadden, R. M., Carroll, K., Donovan, D., Cooney, N. L., Monti, P., Abrams, D., et al. (1992). Cognitive-behavioral coping skills therapy manual: A clinical research guide for therapists treating individuals with alcohol abuse and dependence (Vol. 3; Project MATCH Monograph, DHHS Publication No 92-1895). Washington, DC: U. S. Government Printing Office.'}, {'type': 'BACKGROUND', 'citation': 'Levitt, J. T., Brown, T. A., Orsillo, S. M., & Barlow, D. H. (2004). The effects of acceptance versus suppression of emotion on subjective and psychophysiological response to carbon dioxide challenge in patients with panic disorder. Behavior Therapy, 35, 747-766.'}, {'type': 'BACKGROUND', 'citation': 'Sharkansky, E. J., Brief, D. P., Peirce, J. M., Meehan, J. C., & Mannix, L. M. (1999). Substance abuse patients with posttraumatic stress disorder (PTSD): Identifying specific triggers of substance use and their associations with PTSD symptoms. Psychology of Addictive Behaviors, 13, 89-97.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post-traumatic stress disorder (PTSD) symptoms in individuals who suffer from PTSD.', 'detailedDescription': 'Alcohol dependence (AD) afflicts nearly 14% of the population (Kessler et al., 1994; Kessler et al., 1997; Regier et al., 1990), and has a chronic and relapsing course (Brownell, Marlatt, Litchenstein, \\& Wilson, 1986). Negative emotional states have consistently been found to maintain alcohol use disorders (AUDs; Cooney, Litt, Morse, Bauer, \\& Gaupp, 1997; Litt, Cooney, Kadden, \\& Gaupp, 1990; Rubonis et al., 1994) and increase the risk of relapse following AUD treatment (Cooney et al., 1997). This relationship is particularly robust among individuals with co-morbid psychiatric disorders, such as posttraumatic stress disorder (PTSD; Coffey et al., 2002; Sharkansy, Brief, Peirce, Meehan, \\& Mannix, 1999; Tate, Brown, Unrod, \\& Ramo, 2004; Waldrop, Back, Verduin, \\& Brady, in press). Likewise, alcohol use may be maintained by a desire to facilitate or prolong positive emotional states (Cooper, Frone, Russell, \\& Mudar, 1992; Simpson, 2003).\n\nMany psychological interventions for AUDs, most notably the majority of cognitive-behavioral treatment (CBT) packages, have thus focused on the development of coping skills to prevent relapse in response to such triggers, and have been demonstrated to be at least moderately effective in promoting abstinence (Miller \\& Wilbourne, 2002). However, attempts to specify the active ingredients of CBT for AD have been disappointing and most studies examining potential mechanisms of change have failed to find the expected relationships (Longabaugh et al., 2005; Morgenstern \\& Longabaugh, 2000). The lack of empirical evidence substantiating coping skills as a mechanism of change for CBT (Morgenstern \\& Longabaugh, 2000) may be due, in part, to the lack of specificity in coping skill interventions. Broadly speaking, two primary foci of coping skill interventions for AUD are 1) increasing cognitive techniques focused on challenging and changing thought patterns, or 2) increasing experiential acceptance by fostering an accepting stance towards internal states, such as through "urge surfing" (Kadden et al., 1992). These two coping skill approaches (cognitive restructuring and experiential acceptance) likely lead to reduced alcohol use through different pathways. Theoretically, experiential acceptance approaches suggest that the mechanism of change in decreasing alcohol use is increased willingness toward internal experience (e.g., emotions, thoughts, sensations), whereas cognitive restructuring approaches suggest that decreased alcohol use results from decreases in negative appraisals brought about by challenging and changing thought patterns. However, this has yet to be systematically evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age at least 18 years\n* current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month\n* current DSM-IV diagnosis of post-traumatic stress disorder (PTSD)\n* capacity to provide informed consent\n* English fluency\n* no planned absences that they would be unable to complete 6 weeks of daily monitoring and study sessions\n* access to a telephone\n* desire to decrease or stop alcohol drinking behavior\n\nExclusion Criteria:\n\n* a history of delirium tremens\n* seizures, in order to ensure that participants will be medically safe to decrease alcohol use\n* opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month\n* currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use)\n* exhibits signs or symptoms of alcohol withdrawal at the time of initial consent\n* acutely suicidal with intent/plan or present an imminent danger to others\n* a current psychotic disorder\n\nFor ethical reasons and because of the preliminary nature of this study, participants may be in ongoing substance abuse or mental health treatment (MH) or may initiate counseling or medications (other than those noted in exclusion criteria) during the course of the study. Mental health treatment involvement will be used as a covariate if it is related to study dependent variables.'}, 'identificationModule': {'nctId': 'NCT00760994', 'acronym': 'COPE', 'briefTitle': 'Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance', 'organization': {'class': 'OTHER', 'fullName': 'Seattle Institute for Biomedical and Clinical Research'}, 'officialTitle': 'Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance', 'orgStudyIdInfo': {'id': '1R21AA017130-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AA017130-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21AA017130', 'link': 'https://reporter.nih.gov/quickSearch/R21AA017130', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 - Experiential Accepatance', 'description': 'Experiential acceptance', 'interventionNames': ['Behavioral: Experiential acceptance']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 - Cognitive Restructuring', 'description': 'Cognitive restructuring', 'interventionNames': ['Behavioral: Cognitive restructuring']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3 - Control', 'description': 'No-intervention control: Nutrition information', 'interventionNames': ['Other: No-intervention control: Nutrition information']}], 'interventions': [{'name': 'Experiential acceptance', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness meditation'], 'description': "The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert \\& Forsyth, 2005; Hayes, Strosahl, \\& Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, \\& Barlow, 2004).", 'armGroupLabels': ['1 - Experiential Accepatance']}, {'name': 'Cognitive restructuring', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive-behavioral therapy'], 'description': "The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992).", 'armGroupLabels': ['2 - Cognitive Restructuring']}, {'name': 'No-intervention control: Nutrition information', 'type': 'OTHER', 'otherNames': ['Plate method', 'Food', 'Nutrition guidelines', 'Diet'], 'description': 'The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.', 'armGroupLabels': ['3 - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Tracy L Simpson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seattle Institute for Biomedical and Clinical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'VA Puget Sound Health Care System', 'class': 'FED'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}