DepressionNCT00818636
Expressive Writing for Co-Occurring Depression and Alcohol Misuse
A study testing Expressive writing (in addition to group therapy as usual). in people with Depression and Alcohol, Drinking, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Alcohol, Drinking
- What is being tested?
- Expressive writing (in addition to group therapy as usual).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Career and Recovery Resources, Inc.
Houston, Texas, 77004
About this study
***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.
Read the 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.
- Conditions
- Depression, Alcohol, Drinking
- Being tested
- Expressive writing (in addition to group therapy as usual).
- Keywords
- expressive writing, ruminating, ruminative thinking, experiential avoidance, depression, alcohol, drinking, emotional processing
- Medical subject headings
- Depression, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writing (in addition to group therapy as usual).Behavioural
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 group | Role | What they receive |
|---|---|---|
| Expressive Writing | Experimental | 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. Receives: Behavioral: Expressive writing (in addition to group therapy as usual). |
| Treatment as Usual | Active comparator | Participants attend group therapy as usual only. Receives: Behavioral: Expressive writing (in addition to group therapy as usual). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory, Second Edition
Measured: Baseline, Post-writing (2 weeks post-baseline), and One Month Follow-Up (Six weeks post-baseline)
Secondary outcomes (1)
Number of Alcoholic Drinks Consumed
Measured: 30 days pre-baseline compared to 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Carrie Dodrill, Baylor College of Medicine
- Investigators
- Carrie L Dodrill, Ph.D., Principal investigator, The University of Texas Health Science Center at Houston- ** This contact information should not be used for counseling or informational purposes**Angela L Stotts, Ph.D., Study chair, The University of Texas Health Science Center at Houston- ** This contact information should not be used for counseling or informational purposes**
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818636
- Sponsor's protocol ID
- 1R03AA016819-01A1
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2009
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.
PubMed 17073523
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing for Co-Occurring Depression and Alcohol Misuse
- ClinicalTrials.gov ID
- NCT00818636
- Acronym / sponsor ID
- 1R03AA016819-01A1
- Conditions
- Depression, Alcohol, Drinking
- Keywords
- expressive writing, ruminating, ruminative thinking, experiential avoidance, depression, alcohol, drinking, emotional processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
***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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing | Experimental | Behavioral: Expressive writing (in addition to group therapy as usual).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. |
| Treatment as Usual | Active comparator | Behavioral: Expressive writing (in addition to group therapy as usual).Participants attend group therapy as usual only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | Expressive Writing, Treatment as Usual |
Primary outcome
Beck Depression Inventory, Second Edition
Time frame: Baseline, Post-writing (2 weeks post-baseline), and One Month Follow-Up (Six weeks post-baseline)
1 secondary outcome
Number of Alcoholic Drinks Consumed
Time frame: 30 days pre-baseline compared to 30 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Background: PubMed 17073523Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.
- 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. This study is only enrolling people at Career and Recovery.Link provided by the sponsor.
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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.
Carrie L Dodrill, Ph.D. principal investigator
The University of Texas Health Science Center at Houston- ** This contact information should not be used for counseling or informational purposes**
Angela L Stotts, Ph.D. study chair
The University of Texas Health Science Center at Houston- ** This contact information should not be used for counseling or informational purposes**
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing (in addition to group therapy as usual). in people with Depression and Alcohol, Drinking, run by Baylor College of Medicine 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 5 inclusion and 6 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 27 Jan 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Beck Depression Inventory, Second Edition (time frame: Baseline, Post-writing (2 weeks post-baseline), and One Month Follow-Up (Six weeks post-baseline)). 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 NCT00818636, which also lists 1 linked publication.
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 27 Jan 2015.