Alcohol DependenceNCT01409707
Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
A study testing Trauma-focused exposure therapy, Motivational enhancement + trauma-focused exposure therapy and Healthy lifestyles sessions in people with Alcohol Dependence and Posttraumatic Stress Disorder, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Dependence, Posttraumatic Stress Disorder
- What is being tested?
- Trauma-focused exposure therapy, Motivational enhancement + trauma-focused exposure therapy and Healthy lifestyles sessions
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2013
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current PTSD
- Current Alcohol Dependence
- at least one heavy drinking day in the past 60 days
Who cannot join
- Psychotic disorder
- Untreated bi-polar disorder
- benzodiazepine use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD
The purpose of this study is to test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.
- Conditions
- Alcohol Dependence, Posttraumatic Stress Disorder
- Being tested
- Trauma-focused exposure therapy, Motivational enhancement + trauma-focused exposure therapy, Healthy lifestyles sessions
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused exposure therapyBehavioural
Also called Prolonged exposure
cognitive behavioral therapy for PTSD
Motivational enhancement + trauma-focused exposure therapyBehavioural
Also called Trauma-focused motivational enhancement therapy, Prolonged Exposure, Motivational Interviewing
Cognitive behavioral therapy for PTSD
Healthy lifestyles sessionsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Healthy lifestyles sessions | Experimental | Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided. Receives: Behavioral: Healthy lifestyles sessions |
| Trauma-focused exposure therapy | Experimental | Trauma focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided. Receives: Behavioral: Trauma-focused exposure therapy |
| Motivational enhancement + trauma-focused exposure therapy | Experimental | A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. Trauma focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided. Receives: Behavioral: Motivational enhancement + trauma-focused exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale-Revised
The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.
Measured: 3-months posttreatment
Timeline Follow Back
The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.
Measured: 3-months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJul 2008
- Primary completionJan 2012
- Study completionMay 2013
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 DependenceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Scott F. Coffey, University of Mississippi Medical Center
- Investigators
- Scott F. Coffey, Ph.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409707
- Sponsor's protocol ID
- 2007-0071
- Other IDs
- R01AA016816
- Status last verified
- Jan 2014
- First submitted
- 2 Aug 2011
- Last updated
- 10 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Change, Motivation, and Treatment Outcome in AD-PTSD
- ClinicalTrials.gov ID
- NCT01409707
- Acronym / sponsor ID
- 2007-0071
- Conditions
- Alcohol Dependence, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Posted 10 Mar 2014
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 test if provision of an effective psychotherapy for Post-traumatic Stress Disorder (PTSD), prolonged exposure, can be tolerated in alcohol dependent patients with PTSD and if it is associated with better treatment outcomes compared to an active control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy lifestyles sessions | Experimental | Behavioral: Healthy lifestyles sessionsHealthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided. |
| Trauma-focused exposure therapy | Experimental | Behavioral: Trauma-focused exposure therapyTrauma focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided. |
| Motivational enhancement + trauma-focused exposure therapy | Experimental | Behavioral: Motivational enhancement + trauma-focused exposure therapyA one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. Trauma focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Current PTSD
- Current Alcohol Dependence
- at least one heavy drinking day in the past 60 days
Key exclusion criteria (3 listed)
- Psychotic disorder
- Untreated bi-polar disorder
- benzodiazepine use
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 |
|---|---|---|
| Trauma-focused exposure therapyAlso: Prolonged exposurecognitive behavioral therapy for PTSD | Behavioural | Trauma-focused exposure therapy |
| Motivational enhancement + trauma-focused exposure therapyAlso: Trauma-focused motivational enhancement therapy, Prolonged Exposure, Motivational InterviewingCognitive behavioral therapy for PTSD | Behavioural | Motivational enhancement + trauma-focused exposure therapy |
| Healthy lifestyles sessions | Behavioural | Healthy lifestyles sessions |
Primary outcome
Impact of Event Scale-Revised
Time frame: 3-months posttreatment
The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.
Timeline Follow Back
Time frame: 3-months posttreatment
The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
- 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.
Scott F. Coffey, Ph.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused exposure therapy, Motivational enhancement + trauma-focused exposure therapy and Healthy lifestyles sessions in people with Alcohol Dependence and Posttraumatic Stress Disorder, run by University of Mississippi Medical Center at 1 site in United States.
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 3 inclusion and 3 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 10 Mar 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2014). 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?
Impact of Event Scale-Revised (time frame: 3-months posttreatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2014.