Trial Outcomes & Findings for Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder (NCT NCT00946322)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Pre- to post-treatment (~20 weeks)

Results posted on

2016-02-08

Participant Flow

1 couple was excluded due to discovery that they did not meet eligibility requirements

Participant milestones

Participant milestones
Measure	Arm 1: CTAP 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.
Pre-treatment STARTED	12
Pre-treatment COMPLETED	11
Pre-treatment NOT COMPLETED	1
Post-treatment STARTED	11
Post-treatment COMPLETED	9
Post-treatment NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: CTAP 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.
Pre-treatment participant failure to follow up	1
Post-treatment participant failure to follow up	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: CTAP n=12 Participants 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.
Age, Continuous	42.22 years STANDARD_DEVIATION 16.14 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

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

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=9 Participants 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.
Clinician-administered PTSD Scale (CAPS) Pre-treatment	58.89 units on a scale Standard Deviation 17.57
Clinician-administered PTSD Scale (CAPS) Post-treatment	40.22 units on a scale Standard Deviation 24.30

PRIMARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

Population: Participants completing pre- and post-treatment assessments were analyzed

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.

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=9 Participants 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.
Percentage Days of Heavy Drinking Pre-treatment	29.01 percentage of days of heavy drinking Standard Deviation 39.16
Percentage Days of Heavy Drinking Post-treatment	16.19 percentage of days of heavy drinking Standard Deviation 29.74

PRIMARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

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

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=9 Participants 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.
Patient-reported PTSD Checklist Pre-treatment	57.72 units on a scale Standard Deviation 13.18
Patient-reported PTSD Checklist Post-treatment	43.78 units on a scale Standard Deviation 17.26

PRIMARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

Population: Participants completing pre- and post-treatment assessment

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=9 Participants 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.
Partner-reported PTSD Checklist Pre-treatment	54.89 units on a scale Standard Deviation 14.31
Partner-reported PTSD Checklist Post-treatment	35.67 units on a scale Standard Deviation 14.67

SECONDARY outcome

Timeframe: Pre- to post-treatment

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

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=7 Participants 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.
Patient-reported Beck Depression Inventory - II (BDI-II) Pre-treatment	27.81 units on a scale Standard Deviation 13.89
Patient-reported Beck Depression Inventory - II (BDI-II) Post-treatment	17.62 units on a scale Standard Deviation 15.18

SECONDARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

Population: Participants completing pre- and post-treatment assessment were analyzed

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=9 Participants 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.
Patient-reported Dyadic Adjustment Scale Pre-treatment	96.12 units on a scale Standard Deviation 25.04
Patient-reported Dyadic Adjustment Scale Post-treatment	100.76 units on a scale Standard Deviation 24.10

SECONDARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

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

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=7 Participants 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.
Partner-reported Beck Depression Inventory - II Pre-treatment	12.63 units on a scale Standard Deviation 9.15
Partner-reported Beck Depression Inventory - II Post-treatment	6.41 units on a scale Standard Deviation 9.87

SECONDARY outcome

Timeframe: Pre- to post-treatment (~20 weeks)

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

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

Outcome measures

Outcome measures
Measure	Arm 1: CTAP n=9 Participants 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.
Partner-reported Dyadic Adjustment Scale Pre-treatment	92.85 units on a scale Standard Deviation 30.08
Partner-reported Dyadic Adjustment Scale Post-treatment	101.49 units on a scale Standard Deviation 21.54

Adverse Events

Arm 1: CTAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeremiah A. Schumm, PhD, Associate Director

Trauma Recovery Center, Cincinnati VA Medical Center

Phone: 859-572-6717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place