Alcohol-related DisordersPhase 1CTAPNCT00946322

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

A Phase 1 study testing Couple-Based Treatment for Alcohol Use Disorders and PTSD in people with Alcohol-related Disorders and Post-traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol-related Disorders, Post-traumatic Stress Disorder
What is being tested?: Couple-Based Treatment for Alcohol Use Disorders and PTSD
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Feb 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220

Other trials in United States

About this study

Official title: Couple-Based Treatment for Alcohol Use Disorders and PTSD

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.

Conditions: Alcohol-related Disorders, Post-traumatic Stress Disorder
Being tested: Couple-Based Treatment for Alcohol Use Disorders and PTSD
Keywords: post-traumatic stress disorder, alcohol-related disorders, substance use disorders, couple therapy
Medical subject headings: Alcohol-Related Disorders, Stress Disorders, Post-Traumatic, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Couple-Based Treatment for Alcohol Use Disorders and PTSDBehavioural
Also called CTAP
This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.

Study groups in NCT00946322
Study group	Role	What they receive
Arm 1: CTAP	Experimental	Couple-Based Treatment for Alcohol Use Disorders and PTSD Receives: Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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.
Measured: Pre- to post-treatment
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.
Measured: 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.
Measured: 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.
Measured: Pre- to post-treatment (~20 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Feb 2015

First posted27 Jul 2009 (estimated)
Study startAug 2010
Primary completionDec 2014
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol-related DisordersStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00946322
Sponsor's protocol ID: CDA-2-019-09S
Acronym: CTAP
Status last verified: Jan 2016
First submitted: 23 Jul 2009
Last updated: 8 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol-related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Couple-Based Treatment for Alcohol Use Disorders and PTSD
ClinicalTrials.gov ID: NCT00946322
Acronym / sponsor ID: CTAP / CDA-2-019-09S
Conditions: Alcohol-related Disorders, Post-traumatic Stress Disorder
Keywords: post-traumatic stress disorder, alcohol-related disorders, substance use disorders, couple therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Aug 2010
Primary completion: Dec 2014 (actual)
Study completion: Feb 2015 (actual)
First posted: 27 Jul 2009 (estimated)
Results: Posted 13 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm 1: CTAP	Experimental	Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSDCouple-Based Treatment for Alcohol Use Disorders and PTSD

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Couple-Based Treatment for Alcohol Use Disorders and PTSDAlso: CTAPThis intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.	Behavioural	Arm 1: CTAP

Primary outcome

Clinician-administered PTSD Scale (CAPS)
Time frame: 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
Time frame: 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
Time frame: 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.
Partner-reported PTSD Checklist
Time frame: 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.

4 secondary outcomes

Patient-reported Beck Depression Inventory - II (BDI-II)
Time frame: Pre- to post-treatment
Patient-reported Dyadic Adjustment Scale
Time frame: Pre- to post-treatment (~20 weeks)
Partner-reported Beck Depression Inventory - II
Time frame: Pre- to post-treatment (~20 weeks)
Partner-reported Dyadic Adjustment Scale
Time frame: Pre- to post-treatment (~20 weeks)

Results and safety

Results posted to the registry on 13 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: CTAP	12	11

Primary outcome: Clinician-administered PTSD Scale (CAPS)

Time frame: Pre- to post-treatment (~20 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1: CTAP n = 9
Pre-treatment	58.89 (17.57)
Post-treatment	40.22 (24.30)

Arm 1: CTAP: p = .028, t-test, 2 sided

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

Primary outcome: Percentage Days of Heavy Drinking

Time frame: Pre- to post-treatment (~20 weeks). Mean (Standard Deviation). Unit: percentage of days of heavy drinking

Measure	Arm 1: CTAP n = 9
Pre-treatment	29.01 (39.16)
Post-treatment	16.19 (29.74)

Arm 1: CTAP: p = .022, t-test, 2 sided

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

Primary outcome: Patient-reported PTSD Checklist

Time frame: Pre- to post-treatment (~20 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1: CTAP n = 9
Pre-treatment	57.72 (13.18)
Post-treatment	43.78 (17.26)

Arm 1: CTAP: p = .009, t-test, 2 sided

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

Primary outcome: Partner-reported PTSD Checklist

Time frame: Pre- to post-treatment (~20 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1: CTAP n = 9
Pre-treatment	54.89 (14.31)
Post-treatment	35.67 (14.67)

Arm 1: CTAP: p = .001, t-test, 2 sided

Population analysed: Participants completing pre- and post-treatment assessment

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During duration of treatment and through post-treatment assessment (~20 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: CTAP	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeremiah A. Schumm, PhD principal investigator

Cincinnati VA Medical Center, Cincinnati, OH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-administered PTSD Scale (CAPS) (time frame: Pre- to post-treatment (~20 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00946322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.