CTAP: Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00946322
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and test a couple-based treatment for Veterans with an alcohol use disorder and post-traumatic stress disorder.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-related Disorders; Post-traumatic Stress Disorder	Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Couple-Based Treatment for Alcohol Use Disorders and PTSD
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: CTAP Couple-Based Treatment for Alcohol Use Disorders and PTSD	Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD; This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.; Other Names: CTAP

Outcome Measures

Primary Outcome Measures

1. Clinician-administered PTSD Scale (CAPS) [Pre- to post-treatment (~20 weeks)]

   Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.

2. Percentage Days of Heavy Drinking [Pre- to post-treatment (~20 weeks)]

   Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans' drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.

3. Patient-reported PTSD Checklist [Pre- to post-treatment (~20 weeks)]

   Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.

4. Partner-reported PTSD Checklist [Pre- to post-treatment (~20 weeks)]

   Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.

Secondary Outcome Measures

1. Patient-reported Beck Depression Inventory - II (BDI-II) [Pre- to post-treatment]

   Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.

2. Patient-reported Dyadic Adjustment Scale [Pre- to post-treatment (~20 weeks)]

   Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.

3. Partner-reported Beck Depression Inventory - II [Pre- to post-treatment (~20 weeks)]

   Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.

4. Partner-reported Dyadic Adjustment Scale [Pre- to post-treatment (~20 weeks)]

   Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veteran must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for current (past 12 months) alcohol abuse or dependence and alcohol must be the Veteran's primary substance of abuse as determined by a clinical algorithm (Fals-Stewart, Stappenbeck et al, 2004);

• Veteran must meet DSM-IV criteria for current (past month) PTSD;

• Veteran consumed alcohol in the past 90 days;

• couple must be married to or living with their current partner for at least 1 year;

• Veteran agrees to a goal of abstinence from drugs at least for the duration of the 15-week study-based treatment;

• Veteran agrees to the goal of abstaining from alcohol or consuming alcohol within low risk drinking guidelines during the duration of the 15-week study-based counseling;

• Veteran agrees to forego other treatment for alcohol-related disorders except for self help meetings (e.g., AA) or treatment required for a clinical emergency or clinical deterioration for the duration of the 15-week study based treatment;

• Veteran agrees to forgo other PTSD treatment except for treatment required for a clinical emergency or clinical deterioration for the duration of the 15-week study based treatment;

• couple agrees to forgo other couple-based counseling for the duration of the 15-week study based treatment except for treatment required for a clinical emergency or clinical deterioration;

• partner does not meet DSM-IV criteria for current (past 12 month) substance use disorder (other than nicotine)

• partner does not meet DSM-IV criteria for current (past month) PTSD.

Exclusion Criteria:

• Veteran has dependence on alcohol or other drugs that requires inpatient treatment or medical detoxification (as indicated by daily heavy use or use to prevent or deal with withdrawal symptoms) - after completing detoxification, Veteran may be eligible for the study;

• Veteran or partner are at immediate risk for suicide or homicide (current plan or intent);

• Veteran or partner exhibit a history of suicide or homicide attempt in the past year;

• Veteran is participating in a methadone maintenance or suboxone maintenance program and is seeking treatment for adjunctive outpatient services;

• Veteran or partner meets DSM-IV criteria for a current organic mental disorder, schizophrenia, delusional (paranoid) disorder, or any of the other psychotic disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati VA Medical Center, Cincinnati, OH	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Jeremiah A. Schumm, PhD, Cincinnati VA Medical Center, Cincinnati, OH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00946322
• Other Study ID Numbers: CDA-2-019-09S
• First Posted: Jul 27, 2009
• Last Update Posted: Feb 8, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by VA Office of Research and Development: post-traumatic stress disorder; alcohol-related disorders; substance use disorders; couple therapy
• Additional relevant MeSH terms: Disease; Alcoholism; Alcohol-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Pre-assignment Detail	1 couple was excluded due to discovery that they did not meet eligibility requirements

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Period Title: Pre-treatment
STARTED	12
COMPLETED	11
NOT COMPLETED	1
Period Title: Pre-treatment
STARTED	11
COMPLETED	9
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.22 (16.14)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	12 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 25%
White	9 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Clinician-administered PTSD Scale (CAPS)
Description	Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing both pre- and post-treatment assessments were analyzed.

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	9
Pre-treatment	58.89 (17.57)
Post-treatment	40.22 (24.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.028
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Percentage Days of Heavy Drinking
Description	Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans' drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing pre- and post-treatment assessments were analyzed

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	9
Pre-treatment	29.01 (39.16)
Post-treatment	16.19 (29.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.022
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Patient-reported Beck Depression Inventory - II (BDI-II)
Description	Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.
Time Frame	Pre- to post-treatment

Outcome Measure Data

Analysis Population Description

Participants completing the BDI-II at pre- and post-treatment were analyzed

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	7
Pre-treatment	27.81 (13.89)
Post-treatment	17.62 (15.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.043
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Patient-reported Dyadic Adjustment Scale
Description	Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing pre- and post-treatment assessment were analyzed

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	9
Pre-treatment	96.12 (25.04)
Post-treatment	100.76 (24.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.482
	Comments
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Patient-reported PTSD Checklist
Description	Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing pre- and post-treatment assessments were included.

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	9
Pre-treatment	57.72 (13.18)
Post-treatment	43.78 (17.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.009
	Comments
	Method	t-test, 2 sided
	Comments

6. Primary Outcome

Title	Partner-reported PTSD Checklist
Description	Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing pre- and post-treatment assessment

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	9
Pre-treatment	54.89 (14.31)
Post-treatment	35.67 (14.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Partner-reported Beck Depression Inventory - II
Description	Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing the pre- and post-treatment assessment were included

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	7
Pre-treatment	12.63 (9.15)
Post-treatment	6.41 (9.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.027
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Partner-reported Dyadic Adjustment Scale
Description	Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.
Time Frame	Pre- to post-treatment (~20 weeks)

Outcome Measure Data

Analysis Population Description

Participants completing pre- and post-treatment assessment were analyzed.

Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Measure Participants	9
Pre-treatment	92.85 (30.08)
Post-treatment	101.49 (21.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: CTAP
	Comments	Paired sample t-test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.177
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	During duration of treatment and through post-treatment assessment (~20 weeks)
Arm/Group Title	Arm 1: CTAP
Arm/Group Description	Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
All Cause Mortality
	Arm 1: CTAP
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm 1: CTAP
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1: CTAP
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

Study was an initial open-trial pilot study. A causal relationship cannot be determined between study interventions and outcomes due to lack of a comparison condition.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.