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Substance-Related DisordersPhase 2NCT00018655

Integrated Intervention for Substance Abusers With Depressive Disorders

A Phase 2 study testing Twelve Step Facilitation and Integrated Cognitive Behavioral Treatment in people with Substance-Related Disorders and Depressive Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Twelve Step Facilitation and Integrated Cognitive Behavioral Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteUnited States
Study dates
Apr 2000to Sep 2012
Phase
Phase 2
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veterans age 18 and older with alcohol, cannabinol, and/or stimulant dependence and independent mood disorders will be included.

Who cannot join

  • Psychotic disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA San Diego Healthcare System, San Diego

    San Diego, California, 92161

Other trials in United States

About this study

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications.

Read the detailed description

This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. Follow-up assessments were conducted at quarterly intervals for one year following treatment.

Being tested
Twelve Step Facilitation, Integrated Cognitive Behavioral Treatment
Keywords
Mood Disorders, Substance-Related Disorders
Medical subject headings
Substance-Related Disorders, Depressive Disorder, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Twelve Step FacilitationBehavioural

    Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.

  • Integrated Cognitive Behavioral TreatmentBehavioural

    Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.

Study groups in NCT00018655
Study groupRoleWhat they receive
Arm 1ExperimentalTwelve Step Facilitation
Receives: Behavioral: Twelve Step Facilitation
Arm 2ExperimentalIntegrated Cognitive Behavioral Treatment
Receives: Behavioral: Integrated Cognitive Behavioral Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Scale, Timeline Follow-back (substance measure)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2001 (estimated)
  2. Study startApr 2000
  3. Primary completionSep 2009
  4. Study completionSep 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00018655
Sponsor's protocol ID
MHBS-041-99S
Status last verified
Apr 2019
First submitted
3 Jul 2001
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Brown SA, Glasner-Edwards SV, Tate SR, McQuaid JR, Chalekian J, Granholm E. Integrated cognitive behavioral therapy versus twelve-step facilitation therapy for substance-dependent adults with depressive disorders. J Psychoactive Drugs. 2006 Dec;38(4):449-60. doi: 10.1080/02791072.2006.10400584.

    PubMed 17373561

  • Drapkin ML, Tate SR, McQuaid JR, Brown SA. Does initial treatment focus influence outcomes for depressed substance abusers? J Subst Abuse Treat. 2008 Oct;35(3):343-50. doi: 10.1016/j.jsat.2007.12.005. Epub 2008 Mar 4.

    PubMed 18295436

  • Glasner-Edwards S, Tate SR, McQuaid JR, Cummins K, Granholm E, Brown SA. Mechanisms of action in integrated cognitive-behavioral treatment versus twelve-step facilitation for substance-dependent adults with comorbid major depression. J Stud Alcohol Drugs. 2007 Sep;68(5):663-72. doi: 10.15288/jsad.2007.68.663.

    PubMed 17690799

  • Lydecker KP, Tate SR, Cummins KM, McQuaid J, Granholm E, Brown SA. Clinical outcomes of an integrated treatment for depression and substance use disorders. Psychol Addict Behav. 2010 Sep;24(3):453-65. doi: 10.1037/a0019943.

    PubMed 20853931

  • Granholm E, Tate SR, Link PC, Lydecker KP, Cummins KM, McQuaid J, Shriver C, Brown SA. Neuropsychological functioning and outcomes of treatment for co-occurring depression and substance use disorders. Am J Drug Alcohol Abuse. 2011 Jul;37(4):240-9. doi: 10.3109/00952990.2011.570829. Epub 2011 Apr 26.

    PubMed 21517712

  • Tate SR, Mrnak-Meyer J, Shriver CL, Atkinson JH, Robinson SK, Brown SA. Predictors of treatment retention for substance-dependent adults with co-occurring depression. Am J Addict. 2011 Jul-Aug;20(4):357-65. doi: 10.1111/j.1521-0391.2011.00137.x. Epub 2011 May 31.

    PubMed 21679267

  • Worley MJ, Trim RS, Roesch SC, Mrnak-Meyer J, Tate SR, Brown SA. Comorbid depression and substance use disorder: longitudinal associations between symptoms in a controlled trial. J Subst Abuse Treat. 2012 Oct;43(3):291-302. doi: 10.1016/j.jsat.2011.12.010. Epub 2012 Mar 8.

    PubMed 22406052

  • Worley MJ, Trim RS, Tate SR, Hall JE, Brown SA. Service utilization during and after outpatient treatment for comorbid substance use disorder and depression. J Subst Abuse Treat. 2010 Sep;39(2):124-31. doi: 10.1016/j.jsat.2010.05.009. Epub 2010 Jul 3.

    PubMed 20598832

  • Mrnak-Meyer J, Tate SR, Tripp JC, Worley MJ, Jajodia A, McQuaid JR. Predictors of suicide-related hospitalization among U.S. veterans receiving treatment for comorbid depression and substance dependence: who is the riskiest of the risky? Suicide Life Threat Behav. 2011 Oct;41(5):532-42. doi: 10.1111/j.1943-278X.2011.00051.x. Epub 2011 Aug 4.

    PubMed 21815915

  • Worley 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

  • Worley 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 23327503

  • Tripp 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 24223036

  • 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 24588403

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Twelve Step Facilitation and Integrated Cognitive Behavioral Treatment in people with Substance-Related Disorders and Depressive Disorder, run by VA Office of Research and Development 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 1 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 19 Apr 2019. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Hamilton Depression Scale, Timeline Follow-back (substance measure) (time frame: 18 months). 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 NCT00018655, which also lists 13 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 19 Apr 2019.

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