Alcohol AbuseNCT00108407
Study Comparing Two Types of Psychotherapy for Treating Depression and Substance Abuse
A study testing Integrated Cognitive Behavioral Therapy and Twelve Step Facilitation Therapy in people with Alcohol Abuse and Cannabis Abuse, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Abuse, Cannabis Abuse, Major Depressive Disorder
- What is being tested?
- Integrated Cognitive Behavioral Therapy and Twelve Step Facilitation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to not given
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with one or more substance use disorders (alcohol, cannabis, and or stimulant abuse/dependence) and an independent co-occurring depressive disorder (major depression or dysthymia) will be included.
Who cannot join
- Individuals with substance induced mood disorders and individuals experiencing persistent psychotic symptoms.
- Those with life threatening or unstable medical illness, neurological disorders, or inability to read will be excluded.
- Individuals currently prescribed steroids, disulfiram, or long acting benzodiazepines will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
About this study
Official title: Integrated CBT for Substance Use and Depressive Disorders
The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders.
Read the detailed description
Depression is the most frequent co-occuring mental health disorder among adults with substance use disorders, and such comorbidity is often associated with poorer treatment outcomes. Although there is an urgent need for effective treatments specific for dual-diagnosis adults, few studies have been conducted to address this need.
Comparison: This study will compare substance use and depression symptoms of individuals in two different psychotherapy groups: Integrated Cognitive Behavioral Therapy and Twelve Step Facilitation Therapy. Symptoms and substance use will be compared during the active treatment phase (24 weeks) and for one year following the end of the active treatment.
- Being tested
- Integrated Cognitive Behavioral Therapy, Twelve Step Facilitation Therapy
- Keywords
- Alcohol Abuse/Dependence, Alcohol Use Disorders, Cannabis Abuse/Dependence, Depression, Dual diagnosis, Dysthymia, Stimulant Abuse/Dependence, Substance Use Disorders
- Medical subject headings
- Alcoholism, Marijuana Abuse, Depressive Disorder, Major, Substance-Related Disorders, Depression, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cognitive Behavioral TherapyBehavioural
Twelve Step Facilitation TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Integrated Cognitive Behavioral Therapy Receives: Behavioral: Integrated Cognitive Behavioral Therapy |
| 2 | Experimental | Twelve Step Facilitation Therapy Receives: Behavioral: Twelve Step Facilitation Therapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Sandra Brown, PhD, Principal investigator, VA San Diego Healthcare System, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108407
- Sponsor's protocol ID
- MHBS-041-99Sa
- Status last verified
- Mar 2009
- First submitted
- 14 Apr 2005
- Last updated
- 6 Mar 2009
- Results posted
- No
Publications
Worley MJ, Tate SR, Granholm E, Brown SA. Mediated and moderated effects of neurocognitive impairment on outcomes of treatment for substance dependence and major depression. J Consult Clin Psychol. 2014 Jun;82(3):418-28. doi: 10.1037/a0036033. Epub 2014 Mar 3.
PubMed 24588403Tripp JC, Skidmore JR, Cui R, Tate SR. Impact of Physical Health on Treatment for Co-occurring Depression and Substance Dependence. J Dual Diagn. 2013;9(3):10.1080/15504263.2013.806111. doi: 10.1080/15504263.2013.806111.
PubMed 24223036Worley MJ, Tate SR, McQuaid JR, Granholm EL, Brown SA. 12-step affiliation and attendance following treatment for comorbid substance dependence and depression: a latent growth curve mediation model. Subst Abus. 2013;34(1):43-50. doi: 10.1080/08897077.2012.691451.
PubMed 23327503Worley MJ, Tate SR, Brown SA. Mediational relations between 12-Step attendance, depression and substance use in patients with comorbid substance dependence and major depression. Addiction. 2012 Nov;107(11):1974-83. doi: 10.1111/j.1360-0443.2012.03943.x. Epub 2012 Aug 10.
PubMed 22578037
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated CBT for Substance Use and Depressive Disorders
- ClinicalTrials.gov ID
- NCT00108407
- Acronym / sponsor ID
- MHBS-041-99Sa
- Keywords
- Alcohol Abuse/Dependence, Alcohol Use Disorders, Cannabis Abuse/Dependence, Depression, Dual diagnosis, Dysthymia, Stimulant Abuse/Dependence, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2004
- First posted
- 15 Apr 2005 (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.
The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders.
Detailed description
Depression is the most frequent co-occuring mental health disorder among adults with substance use disorders, and such comorbidity is often associated with poorer treatment outcomes. Although there is an urgent need for effective treatments specific for dual-diagnosis adults, few studies have been conducted to address this need.
Comparison: This study will compare substance use and depression symptoms of individuals in two different psychotherapy groups: Integrated Cognitive Behavioral Therapy and Twelve Step Facilitation Therapy. Symptoms and substance use will be compared during the active treatment phase (24 weeks) and for one year following the end of the active treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Integrated Cognitive Behavioral TherapyIntegrated Cognitive Behavioral Therapy |
| 2 | Experimental | Behavioral: Twelve Step Facilitation TherapyTwelve Step Facilitation Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with one or more substance use disorders (alcohol, cannabis, and or stimulant abuse/dependence) and an independent co-occurring depressive disorder (major depression or dysthymia) will be included.
Key exclusion criteria (3 listed)
- Individuals with substance induced mood disorders and individuals experiencing persistent psychotic symptoms.
- Those with life threatening or unstable medical illness, neurological disorders, or inability to read will be excluded.
- Individuals currently prescribed steroids, disulfiram, or long acting benzodiazepines will be excluded.
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 |
|---|---|---|
| Integrated Cognitive Behavioral Therapy | Behavioural | 1 |
| Twelve Step Facilitation Therapy | Behavioural | 2 |
Primary outcome
Not reported in the source record.
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 6 Mar 2009.
- Derived from this study: PubMed 24588403Worley MJ, Tate SR, Granholm E, Brown SA. Mediated and moderated effects of neurocognitive impairment on outcomes of treatment for substance dependence and major depression. J Consult Clin Psychol. 2014 Jun;82(3):418-28. doi: 10.1037/a0036033. Epub 2014 Mar 3.
- Derived from this study: PubMed 24223036Tripp JC, Skidmore JR, Cui R, Tate SR. Impact of Physical Health on Treatment for Co-occurring Depression and Substance Dependence. J Dual Diagn. 2013;9(3):10.1080/15504263.2013.806111. doi: 10.1080/15504263.2013.806111.
- Derived from this study: PubMed 23327503Worley MJ, Tate SR, McQuaid JR, Granholm EL, Brown SA. 12-step affiliation and attendance following treatment for comorbid substance dependence and depression: a latent growth curve mediation model. Subst Abus. 2013;34(1):43-50. doi: 10.1080/08897077.2012.691451.
- Derived from this study: PubMed 22578037Worley MJ, Tate SR, Brown SA. Mediational relations between 12-Step attendance, depression and substance use in patients with comorbid substance dependence and major depression. Addiction. 2012 Nov;107(11):1974-83. doi: 10.1111/j.1360-0443.2012.03943.x. Epub 2012 Aug 10.
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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.
Sandra Brown, PhD principal investigator
VA San Diego Healthcare System, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Cognitive Behavioral Therapy and Twelve Step Facilitation Therapy in people with Alcohol Abuse and Cannabis Abuse, run by US Department of Veterans Affairs 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 1 inclusion and 3 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 6 Mar 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108407, which also lists 4 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 6 Mar 2009.