Expressive Writing for Co-Occurring Depression and Alcohol Misuse
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ClinicalTrials.gov Identifier: NCT00818636 |
Recruitment Status :
Completed
First Posted : January 8, 2009
Last Update Posted : January 27, 2015
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 6, 2009 | ||||||
First Posted Date ICMJE | January 8, 2009 | ||||||
Last Update Posted Date | January 27, 2015 | ||||||
Study Start Date ICMJE | August 2008 | ||||||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Beck Depression Inventory, Second Edition [ Time Frame: Baseline, Post-writing (2 weeks post-baseline), and One Month Follow-Up (Six weeks post-baseline) ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Number of Alcoholic Drinks Consumed [ Time Frame: 30 days pre-baseline compared to 30 days post-intervention ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Expressive Writing for Co-Occurring Depression and Alcohol Misuse | ||||||
Official Title ICMJE | Expressive Writing for Co-Occurring Depression and Alcohol Misuse | ||||||
Brief Summary | ***Please note that this study does not offer comprehensive treatment program for alcohol abuse or depression. Please do not contact the study staff if you are seeking psychological treatment. Further, this study is only enrolling people who are clients at Career and Recovery Resources, Inc., in Houston. The hypothesis is that writing about feelings and thoughts will help people who are in group treatment feel less depressed and abuse alcohol less. |
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Detailed Description | Expressive writing applied to a variety of populations (e.g., HIV, cancer, PTSD, depression) has been associated with health improvements, reductions in symptoms of emotional distress, and one preliminary study found reductions in alcohol misuse among college students. Data suggest that expressive writing is a technique to facilitate emotional processing that can influence a number of clinical outcomes by facilitating cognitive restructuring (Hunt, 1998; Pennebaker, 2004). In addition to examining cognitive content change following expressive writing, we believe the effects of emotional writing on mood and drinking may involve two additional processes that have been found significant for both depression and alcohol misuse, namely experiential avoidance and ruminative thinking. We hypothesize that expressive writing will lead to less drinking and enhanced mood by reducing: (1) negative thought content, (2) experiential avoidance of unpleasant private events (e.g., negative thoughts, feelings, bodily sensations), and (3) ruminative thinking. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Expressive writing (in addition to group therapy as usual).
Participants in the expressive writing condition write about their feelings about an issue of their choosing three times, for at least 20 minutes each time, during a two week period.
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Study Arms ICMJE |
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Publications * | Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
89 | ||||||
Original Estimated Enrollment ICMJE |
160 | ||||||
Actual Study Completion Date ICMJE | December 2011 | ||||||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | ***Please note that this study does not offer comprehensive treatment program for alcohol abuse or depression. Please do not contact the study staff if you are seeking psychological treatment. Further, this study is only enrolling people who are clients at Career and Recovery Resources, Inc., in Houston. Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00818636 | ||||||
Other Study ID Numbers ICMJE | 1R03AA016819-01A1( U.S. NIH Grant/Contract ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Carrie Dodrill, Baylor College of Medicine | ||||||
Study Sponsor ICMJE | Baylor College of Medicine | ||||||
Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||||||
Investigators ICMJE |
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PRS Account | Baylor College of Medicine | ||||||
Verification Date | January 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |