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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: CTAP | Experimental | Couple-Based Treatment for Alcohol Use Disorders and PTSD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Couple-Based Treatment for Alcohol Use Disorders and PTSD | Behavioral | This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-administered PTSD Scale (CAPS) | Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135. | Pre- to post-treatment (~20 weeks) |
| 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. | Pre- to post-treatment (~20 weeks) |
| 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. | Pre- to post-treatment (~20 weeks) |
| 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. | Pre- to post-treatment (~20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- to post-treatment |
| Patient-reported Dyadic Adjustment Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremiah A. Schumm, PhD | Cincinnati VA Medical Center, Cincinnati, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220 | United States |
1 couple was excluded due to discovery that they did not meet eligibility requirements
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-treatment |
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| Post-treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician-administered PTSD Scale (CAPS) | Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135. | Participants completing both pre- and post-treatment assessments were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment (~20 weeks) |
|
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During duration of treatment and through post-treatment assessment (~20 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremiah A. Schumm, PhD, Associate Director | Trauma Recovery Center, Cincinnati VA Medical Center | 859-572-6717 | Jeremiah.Schumm@va.gov |
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| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.
| Pre- to post-treatment (~20 weeks) |
| Partner-reported Beck Depression Inventory - II | Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse. | Pre- to post-treatment (~20 weeks) |
| 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. | Pre- to post-treatment (~20 weeks) |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
|
| 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. | Participants completing pre- and post-treatment assessments were analyzed | Posted | Mean | Standard Deviation | percentage of days of heavy drinking | Pre- to post-treatment (~20 weeks) |
|
|
|
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| 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. | Participants completing the BDI-II at pre- and post-treatment were analyzed | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment |
|
|
|
|
| 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. | Participants completing pre- and post-treatment assessment were analyzed | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment (~20 weeks) |
|
|
|
|
| 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. | Participants completing pre- and post-treatment assessments were included. | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment (~20 weeks) |
|
|
|
|
| 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. | Participants completing pre- and post-treatment assessment | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment (~20 weeks) |
|
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|
|
| Secondary | Partner-reported Beck Depression Inventory - II | Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse. | Participants completing the pre- and post-treatment assessment were included | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment (~20 weeks) |
|
|
|
|
| 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. | Participants completing pre- and post-treatment assessment were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Pre- to post-treatment (~20 weeks) |
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| 0 |
| 12 |
| 0 |
| 12 |
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