Trial Outcomes & Findings for Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder (NCT NCT01409707)
NCT ID: NCT01409707
Last Updated: 2014-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
3-months posttreatment
Results posted on
2014-03-10
Participant Flow
Recruitment occurred at a residential substance abuse treatment facility between July 2008 and June 2011.
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.).
Participant milestones
| Measure |
Healthy Lifestyles Sessions
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.
|
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 PTSD. Nine to 12 50-60 minutes sessions were provided.
|
Motivational Enhancement + Trauma-focused Exposure Therapy
A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. 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 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
45
|
40
|
|
Overall Study
COMPLETED
|
36
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
17
|
16
|
Reasons for withdrawal
| Measure |
Healthy Lifestyles Sessions
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.
|
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 PTSD. Nine to 12 50-60 minutes sessions were provided.
|
Motivational Enhancement + Trauma-focused Exposure Therapy
A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. 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 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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
17
|
16
|
Baseline Characteristics
Mechanisms of Change, Motivation, and Treatment Outcome in Alcohol Dependence - Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Healthy Lifestyles Sessions
n=41 Participants
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.
|
Trauma-focused Exposure Therapy
n=45 Participants
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.
|
Motivational Enhancement + Trauma-focused Exposure Therapy
n=40 Participants
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.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
32.85 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
34.67 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
34.40 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
33.72 years
STANDARD_DEVIATION 10.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
40 participants
n=5 Participants
|
126 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3-months posttreatmentPopulation: All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.
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.
Outcome measures
| Measure |
Healthy Lifestyles Sessions
n=41 Participants
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.
|
Trauma-focused Exposure Therapy
n=45 Participants
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.
|
Motivational Enhancement + Trauma-focused Exposure Therapy
n=40 Participants
One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused 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.
|
|---|---|---|---|
|
Impact of Event Scale-Revised
|
26.00 units on a scale
Standard Error 2.98
|
19.10 units on a scale
Standard Error 3.10
|
14.11 units on a scale
Standard Error 2.95
|
PRIMARY outcome
Timeframe: 3-months posttreatmentPopulation: All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.
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.
Outcome measures
| Measure |
Healthy Lifestyles Sessions
n=41 Participants
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.
|
Trauma-focused Exposure Therapy
n=45 Participants
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.
|
Motivational Enhancement + Trauma-focused Exposure Therapy
n=40 Participants
One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused 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.
|
|---|---|---|---|
|
Timeline Follow Back
|
97.95 percentage of days abstinent
Standard Error 4.25
|
97.83 percentage of days abstinent
Standard Error 4.30
|
92.12 percentage of days abstinent
Standard Error 4.38
|
Adverse Events
Healthy Lifestyles Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trauma-focused Exposure Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Scott Coffey
University of Mississippi Medical Center
Phone: 601-815-5588
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place