NCT00018655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

9.4 years

First QC Date

July 3, 2001

Last Update Submit

April 17, 2019

Conditions

Substance-Related DisordersDepressive Disorder

Keywords

Mood DisordersSubstance-Related Disorders

Outcome Measures

Primary Outcomes (1)

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

    18 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Twelve Step Facilitation

Behavioral: Twelve Step Facilitation

Arm 2

EXPERIMENTAL

Integrated Cognitive Behavioral Treatment

Behavioral: Integrated Cognitive Behavioral Treatment

Interventions

Twelve Step FacilitationBEHAVIORAL

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

Arm 1
Integrated Cognitive Behavioral TreatmentBEHAVIORAL

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

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychotic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Publications (13)

  • 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.

    PMID: 17373561BACKGROUND

  • 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.

    PMID: 18295436RESULT

  • 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.

    PMID: 17690799RESULT

  • 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.

    PMID: 20853931RESULT

  • 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.

    PMID: 21517712RESULT

  • 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.

    PMID: 21679267RESULT

  • 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.

    PMID: 22406052RESULT

  • 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.

    PMID: 20598832RESULT

  • 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.

    PMID: 21815915RESULT

  • 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.

    PMID: 22578037RESULT

  • 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.

    PMID: 23327503RESULT

  • 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.

    PMID: 24223036RESULT

  • 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.

    PMID: 24588403DERIVED

MeSH Terms

Conditions

Substance-Related DisordersDepressive DisorderMood Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Susan Tate, PhD

    VA San Diego Healthcare System, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

April 1, 2000

Primary Completion

September 1, 2009

Study Completion

September 1, 2012

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

US(1)