Alcohol Dependence, Posttraumatic Stress Disorder
Conditions
Brief 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.
Interventions
BEHAVIORALTrauma-focused exposure therapy
cognitive behavioral therapy for PTSD
BEHAVIORALMotivational enhancement + trauma-focused exposure therapy
Cognitive behavioral therapy for PTSD
BEHAVIORALHealthy lifestyles sessions
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Current PTSD * Current Alcohol Dependence * at least one heavy drinking day in the past 60 days
Exclusion criteria
* Psychotic disorder * Untreated bi-polar disorder * benzodiazepine use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Event Scale-Revised | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred at a residential substance abuse treatment facility between July 2008 and June 2011.
Pre-assignment details
222 assessed; 96 ineligible. 53 did not have current PTSD, 6 did not have current alcohol dependence (AD), and 2 did not have either current PTSD or AD. 35 participants were ineligible for other reasons (e.g., current mania, current psychosis, etc.).
Participants by arm
| Arm | Count |
|---|---|
| Healthy Lifestyles Sessions HLS 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. | 41 |
| Trauma-focused Exposure Therapy EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided. | 45 |
| Motivational Enhancement + Trauma-focused Exposure Therapy A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided. | 40 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 17 | 16 |
Baseline characteristics
| Characteristic | Trauma-focused Exposure Therapy | Motivational Enhancement + Trauma-focused Exposure Therapy | Healthy Lifestyles Sessions | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 40 Participants | 41 Participants | 126 Participants |
| Age, Continuous | 34.67 years STANDARD_DEVIATION 10.33 | 34.40 years STANDARD_DEVIATION 10.65 | 32.85 years STANDARD_DEVIATION 10.67 | 33.72 years STANDARD_DEVIATION 10.25 |
| Region of Enrollment United States | 45 participants | 40 participants | 41 participants | 126 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 21 Participants | 58 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 20 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 82 |
| serious Total, serious adverse events | 0 / 38 | 0 / 82 |
Outcome results
Primary
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.
Time frame: 3-months posttreatment
Population: All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Lifestyles Sessions | Impact of Event Scale-Revised | 26.00 units on a scale | Standard Error 2.98 |
| Trauma-focused Exposure Therapy | Impact of Event Scale-Revised | 19.10 units on a scale | Standard Error 3.1 |
| Motivational Enhancement + Trauma-focused Exposure Therapy | Impact of Event Scale-Revised | 14.11 units on a scale | Standard Error 2.95 |
Comparison: Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.p-value: =0.068Mixed Models Analysis
Primary
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.
Time frame: 3-months posttreatment
Population: All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Lifestyles Sessions | Timeline Follow Back | 97.95 percentage of days abstinent | Standard Error 4.25 |
| Trauma-focused Exposure Therapy | Timeline Follow Back | 97.83 percentage of days abstinent | Standard Error 4.3 |
| Motivational Enhancement + Trauma-focused Exposure Therapy | Timeline Follow Back | 92.12 percentage of days abstinent | Standard Error 4.38 |
Comparison: Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.p-value: =0.39Mixed Models Analysis