Alcohol-related Disorders, Post-traumatic Stress Disorder
Conditions
Keywords
post-traumatic stress disorder, alcohol-related disorders, substance use disorders, couple therapy
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.
Interventions
BEHAVIORALCouple-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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
1 couple was excluded due to discovery that they did not meet eligibility requirements
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Post-treatment | participant failure to follow up | 2 |
| Pre-treatment | participant failure to follow up | 1 |
Baseline characteristics
| Characteristic | Arm 1: CTAP |
|---|---|
| Age, Continuous | 42.22 years STANDARD_DEVIATION 16.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Clinician-administered PTSD Scale (CAPS)
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)
Population: Participants completing both pre- and post-treatment assessments were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Clinician-administered PTSD Scale (CAPS) | Pre-treatment | 58.89 units on a scale | Standard Deviation 17.57 |
| Arm 1: CTAP | Clinician-administered PTSD Scale (CAPS) | Post-treatment | 40.22 units on a scale | Standard Deviation 24.3 |
Comparison: Paired sample t-testp-value: 0.028t-test, 2 sided
Primary
Partner-reported PTSD Checklist
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)
Population: Participants completing pre- and post-treatment assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Partner-reported PTSD Checklist | Pre-treatment | 54.89 units on a scale | Standard Deviation 14.31 |
| Arm 1: CTAP | Partner-reported PTSD Checklist | Post-treatment | 35.67 units on a scale | Standard Deviation 14.67 |
Comparison: Paired sample t-testp-value: 0.001t-test, 2 sided
Primary
Patient-reported PTSD Checklist
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)
Population: Participants completing pre- and post-treatment assessments were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Patient-reported PTSD Checklist | Pre-treatment | 57.72 units on a scale | Standard Deviation 13.18 |
| Arm 1: CTAP | Patient-reported PTSD Checklist | Post-treatment | 43.78 units on a scale | Standard Deviation 17.26 |
Comparison: Paired sample t-testp-value: 0.009t-test, 2 sided
Primary
Percentage Days of Heavy Drinking
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)
Population: Participants completing pre- and post-treatment assessments were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Percentage Days of Heavy Drinking | Pre-treatment | 29.01 percentage of days of heavy drinking | Standard Deviation 39.16 |
| Arm 1: CTAP | Percentage Days of Heavy Drinking | Post-treatment | 16.19 percentage of days of heavy drinking | Standard Deviation 29.74 |
Comparison: Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.p-value: 0.022t-test, 2 sided
Secondary
Partner-reported Beck Depression Inventory - II
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)
Population: Participants completing the pre- and post-treatment assessment were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Partner-reported Beck Depression Inventory - II | Pre-treatment | 12.63 units on a scale | Standard Deviation 9.15 |
| Arm 1: CTAP | Partner-reported Beck Depression Inventory - II | Post-treatment | 6.41 units on a scale | Standard Deviation 9.87 |
Comparison: Paired sample t-testp-value: 0.027t-test, 2 sided
Secondary
Partner-reported Dyadic Adjustment Scale
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)
Population: Participants completing pre- and post-treatment assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Partner-reported Dyadic Adjustment Scale | Pre-treatment | 92.85 units on a scale | Standard Deviation 30.08 |
| Arm 1: CTAP | Partner-reported Dyadic Adjustment Scale | Post-treatment | 101.49 units on a scale | Standard Deviation 21.54 |
Comparison: Paired sample t-testp-value: 0.177t-test, 2 sided
Secondary
Patient-reported Beck Depression Inventory - II (BDI-II)
Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.
Time frame: Pre- to post-treatment
Population: Participants completing the BDI-II at pre- and post-treatment were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Patient-reported Beck Depression Inventory - II (BDI-II) | Pre-treatment | 27.81 units on a scale | Standard Deviation 13.89 |
| Arm 1: CTAP | Patient-reported Beck Depression Inventory - II (BDI-II) | Post-treatment | 17.62 units on a scale | Standard Deviation 15.18 |
Comparison: Paired sample t-testp-value: 0.043t-test, 2 sided
Secondary
Patient-reported Dyadic Adjustment Scale
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)
Population: Participants completing pre- and post-treatment assessment were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: CTAP | Patient-reported Dyadic Adjustment Scale | Pre-treatment | 96.12 units on a scale | Standard Deviation 25.04 |
| Arm 1: CTAP | Patient-reported Dyadic Adjustment Scale | Post-treatment | 100.76 units on a scale | Standard Deviation 24.1 |
Comparison: Paired sample t-testp-value: 0.482t-test, 2 sided