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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00018655
Other study ID # MHBS-041-99S
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2000
Est. completion date September 2012

Study information

Verified date April 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 Facilitation (AA/NA model) group treatment plus medications.


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.


Recruitment information / eligibility

Status Completed
Enrollment 276
Est. completion date September 2012
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Psychotic disorders

Study Design


Intervention

Behavioral:
Twelve Step Facilitation
Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.
Integrated Cognitive Behavioral Treatment
Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.

Locations

Country Name City State
United States VA San Diego Healthcare System, San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 Thre — View Citation

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 — View Citation

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). doi: 10.1080/15504263.2013.806111. — View Citation

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. E — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Scale, Timeline Follow-back (substance measure) 18 months
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