AlcoholismCOPENCT00760994
Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
A study testing Experiential acceptance and Cognitive restructuring in people with Alcoholism and Stress Disorders, Post-Traumatic, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Stress Disorders, Post-Traumatic
- What is being tested?
- Experiential acceptance and Cognitive restructuring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age at least 18 years
- current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month
- current DSM-IV diagnosis of post-traumatic stress disorder (PTSD)
- capacity to provide informed consent
- English fluency
- no planned absences that they would be unable to complete 6 weeks of daily monitoring and study sessions
- access to a telephone
- desire to decrease or stop alcohol drinking behavior
Who cannot join
- a history of delirium tremens
- seizures, in order to ensure that participants will be medically safe to decrease alcohol use
- opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month
- currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use)
- exhibits signs or symptoms of alcohol withdrawal at the time of initial consent
- acutely suicidal with intent/plan or present an imminent danger to others
- a current psychotic disorder
- For 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance
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.
Read the detailed description
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).
Many 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.
- Conditions
- Alcoholism, Stress Disorders, Post-Traumatic
- Being tested
- Experiential acceptance, Cognitive restructuring, No-intervention control: Nutrition information
- Keywords
- Alcohol, Alcoholic, Alcoholism, Post-traumatic stress disorder, PTSD, Experiential acceptance, Mindfulness, Meditation, Meditate, Cognitive restructuring, Cognitive, Behavioral, Therapy, Treatment, Study, Intervention
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential acceptanceBehavioural
Also called Mindfulness meditation
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).
Cognitive restructuringBehavioural
Also called Cognitive-behavioral therapy
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).
No-intervention control: Nutrition informationOther
Also called Plate method, Food, Nutrition guidelines, Diet
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Experiential Accepatance | Experimental | Experiential acceptance Receives: Behavioral: Experiential acceptance |
| 2 - Cognitive Restructuring | Active comparator | Cognitive restructuring Receives: Behavioral: Cognitive restructuring |
| 3 - Control | Placebo comparator | No-intervention control: Nutrition information Receives: Other: No-intervention control: Nutrition information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)
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.
Measured: 5 weeks
Secondary outcomes (1)
Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Puget Sound Health Care System, University of Washington
- Responsible party
- Sponsor
- Investigators
- Tracy L Simpson, Ph.D., Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760994
- Sponsor's protocol ID
- 1R21AA017130-01
- Other IDs
- R21AA017130
- Acronym
- COPE
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2008
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 2343787Brownell 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.
PubMed 3527003Cooney 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.
PubMed 9131844Coffey 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.
PubMed 11772473Cooper ML, Frone MR, Russell M, Mudar P. Drinking to regulate positive and negative emotions: a motivational model of alcohol use. J Pers Soc Psychol. 1995 Nov;69(5):990-1005. doi: 10.1037//0022-3514.69.5.990.
PubMed 7473043Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
PubMed 8279933Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.
PubMed 9107147Longabaugh R, Donovan DM, Karno MP, McCrady BS, Morgenstern J, Tonigan JS. Active ingredients: how and why evidence-based alcohol behavioral treatment interventions work. Alcohol Clin Exp Res. 2005 Feb;29(2):235-47. doi: 10.1097/01.alc.0000153541.78005.1f.
PubMed 15714046Miller WR, Wilbourne PL. Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction. 2002 Mar;97(3):265-77. doi: 10.1046/j.1360-0443.2002.00019.x.
PubMed 11964100Morgenstern J, Longabaugh R. Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. Addiction. 2000 Oct;95(10):1475-90. doi: 10.1046/j.1360-0443.2000.951014753.x.
PubMed 11070524Regier DA, Farmer ME, Rae DS, Locke BZ, Keith SJ, Judd LL, Goodwin FK. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA. 1990 Nov 21;264(19):2511-8.
PubMed 2232018Rubonis 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.
PubMed 7934057Simpson 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.
PubMed 12625430Tate 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.
PubMed 15530716Eifert, 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance
- ClinicalTrials.gov ID
- NCT00760994
- Acronym / sponsor ID
- COPE / 1R21AA017130-01
- Conditions
- Alcoholism, Stress Disorders, Post-Traumatic
- Keywords
- Alcohol, Alcoholic, Alcoholism, Post-traumatic stress disorder, PTSD, Experiential acceptance, Mindfulness, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), VA Puget Sound Health Care System, University of Washington
- Study start
- Jan 2009 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 10 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Many 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Experiential Accepatance | Experimental | Behavioral: Experiential acceptanceExperiential acceptance |
| 2 - Cognitive Restructuring | Active comparator | Behavioral: Cognitive restructuringCognitive restructuring |
| 3 - Control | Placebo comparator | Other: No-intervention control: Nutrition informationNo-intervention control: Nutrition information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age at least 18 years
- current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month
- current DSM-IV diagnosis of post-traumatic stress disorder (PTSD)
- capacity to provide informed consent
- English fluency
Key exclusion criteria (8 listed)
- a history of delirium tremens
- seizures, in order to ensure that participants will be medically safe to decrease alcohol use
- opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month
- currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use)
- exhibits signs or symptoms of alcohol withdrawal at the time of initial consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiential acceptanceAlso: Mindfulness meditationThe 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). | Behavioural | 1 - Experiential Accepatance |
| Cognitive restructuringAlso: Cognitive-behavioral therapyThe 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). | Behavioural | 2 - Cognitive Restructuring |
| No-intervention control: Nutrition informationAlso: Plate method, Food, Nutrition guidelines, DietThe 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. | Other | 3 - Control |
Primary outcome
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)
Time frame: 5 weeks
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.
1 secondary outcome
Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2343787Litt 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.
- Background: PubMed 3527003Brownell 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.
- Background: PubMed 9131844Cooney 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.
- Background: PubMed 11772473Coffey 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.
- Background: PubMed 7473043Cooper ML, Frone MR, Russell M, Mudar P. Drinking to regulate positive and negative emotions: a motivational model of alcohol use. J Pers Soc Psychol. 1995 Nov;69(5):990-1005. doi: 10.1037//0022-3514.69.5.990.
- Background: PubMed 8279933Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS. Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States. Results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994 Jan;51(1):8-19. doi: 10.1001/archpsyc.1994.03950010008002.
- Background: PubMed 9107147Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.
- Background: PubMed 15714046Longabaugh R, Donovan DM, Karno MP, McCrady BS, Morgenstern J, Tonigan JS. Active ingredients: how and why evidence-based alcohol behavioral treatment interventions work. Alcohol Clin Exp Res. 2005 Feb;29(2):235-47. doi: 10.1097/01.alc.0000153541.78005.1f.
- Background: PubMed 11964100Miller WR, Wilbourne PL. Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction. 2002 Mar;97(3):265-77. doi: 10.1046/j.1360-0443.2002.00019.x.
- Background: PubMed 11070524Morgenstern J, Longabaugh R. Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. Addiction. 2000 Oct;95(10):1475-90. doi: 10.1046/j.1360-0443.2000.951014753.x.
- Background: PubMed 2232018Regier DA, Farmer ME, Rae DS, Locke BZ, Keith SJ, Judd LL, Goodwin FK. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA. 1990 Nov 21;264(19):2511-8.
- Background: PubMed 7934057Rubonis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy L Simpson, Ph.D. principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiential acceptance and Cognitive restructuring in people with Alcoholism and Stress Disorders, Post-Traumatic, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760994, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.