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Expressive Writing for Co-Occurring Depression and Alcohol Misuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818636
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : January 27, 2015
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Carrie Dodrill, Baylor College of Medicine

Tracking Information
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
 (submitted: January 6, 2009)
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
 (submitted: January 6, 2009)
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.

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
Condition  ICMJE
  • Depression
  • Alcohol, Drinking
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.
Study Arms  ICMJE
  • Experimental: Expressive Writing
    In addition to attending group therapy as usual, participants write about their feelings about an issue of their choosing three times during a two week period for at least 20 minutes each time.
    Intervention: Behavioral: Expressive writing (in addition to group therapy as usual).
  • Active Comparator: Treatment as Usual
    Participants attend group therapy as usual only.
    Intervention: Behavioral: Expressive writing (in addition to group therapy as usual).
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2015)
89
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)
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:

  • Enrolled in group therapy program at Career and Recovery Resources, Inc.
  • Must be at least 18.
  • Willing and able to participate in the study through the one month follow up.
  • Able to provide the contact information of at least two people who can generally locate their whereabouts.
  • Speak English fluently.

Exclusion Criteria:

  • Inability to read, write, speak English.
  • History of bipolar or psychotic disorders.
  • Severe medical, cognitive and /or psychiatric impairment that precludes cooperation with study protocol.
  • Substance withdrawal symptoms requiring medical attention.
  • Currently receiving other individual psychosocial therapy outside of C&R for substance abuse or other psychiatric conditions with the exception of AA, NA or CA.
  • Impending incarceration or other factor that would create inability or unwillingness to participate in the 6 week long study period (e.g., halfway house or other aftercare program restrictions).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Carrie L Dodrill, Ph.D. The University of Texas Health Science Center at Houston- ** This contact information should not be used for counseling or informational purposes**
Study Chair: Angela L Stotts, Ph.D. The University of Texas Health Science Center at Houston- ** This contact information should not be used for counseling or informational purposes**
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