Trial Outcomes & Findings for Integrated Alcohol Disorder and PTSD Treatment (NCT NCT01601067)
NCT ID: NCT01601067
Last Updated: 2019-08-08
Results Overview
The CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
baseline through 6 month follow-up
Results posted on
2019-08-08
Participant Flow
Participants contacted our study in response to 1) flyers posted in VA mental health, primary care, and alcohol and substance use treatment programs; 2) from advertisements in print and web-based media; and 3) by VA primary care, SAMI, PTSD, and other psychiatry clinics
Enrolled participants were excluded from the study for the following reasons: 27 did not meet inclusion criteria; 15 did not complete intake or did not return for intake following informed consent;5 refused research after consent; 2 had travel or logistical constrains.
Participant milestones
| Measure |
Arm 1: Integrated Prolonged Exposure Therapy
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
|
Arm 2: Seeking Safety
Seeking Safety
Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
56
|
|
Overall Study
COMPLETED
|
30
|
34
|
|
Overall Study
NOT COMPLETED
|
33
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Alcohol Disorder and PTSD Treatment
Baseline characteristics by cohort
| Measure |
Arm 1: Integrated Prolonged Exposure Therapy
n=63 Participants
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
|
Arm 2: Seeking Safety
n=56 Participants
Seeking Safety
Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unavailable
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through 6 month follow-upThe CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.
Outcome measures
| Measure |
Arm 1: Integrated Prolonged Exposure Therapy
n=63 Participants
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
|
Arm 2: Seeking Safety
n=56 Participants
Seeking Safety
Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
Baseline
|
43.2 score on a scale
Interval 40.0 to 46.4
|
42.1 score on a scale
Interval 38.7 to 45.5
|
|
Clinician Administered PTSD Scale (CAPS)
After Treatment
|
25.8 score on a scale
Interval 22.1 to 29.6
|
32.9 score on a scale
Interval 29.3 to 36.6
|
|
Clinician Administered PTSD Scale (CAPS)
3 month follow-up
|
26.4 score on a scale
Interval 22.6 to 30.3
|
31.0 score on a scale
Interval 27.0 to 35.1
|
|
Clinician Administered PTSD Scale (CAPS)
6 month follow-up
|
22.5 score on a scale
Interval 18.2 to 26.8
|
29.8 score on a scale
Interval 25.6 to 33.9
|
SECONDARY outcome
Timeframe: baseline to 6-month follow-upFrequency and quantity of alcohol use were assessed using the Timeline Follow-Back, a calendar-assisted structured clinical interview that displays good psychometric properties. The PHDD was calculated by dividing the number of days in which 5 or more drinks for men or 4 or more drinks for women were consumed by the total number of days in the reference period.
Outcome measures
| Measure |
Arm 1: Integrated Prolonged Exposure Therapy
n=63 Participants
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
|
Arm 2: Seeking Safety
n=56 Participants
Seeking Safety
Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
|
|---|---|---|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days heavy drinking - baseline
|
52.5 percentage of days
Interval 46.5 to 58.6
|
50.4 percentage of days
Interval 44.1 to 56.7
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days heavy drinking -After treatment
|
21.0 percentage of days
Interval 13.4 to 28.6
|
17.4 percentage of days
Interval 10.4 to 24.5
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days heavy drinking - 3 month follow up
|
14.2 percentage of days
Interval 6.9 to 21.4
|
15.0 percentage of days
Interval 7.1 to 22.8
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days heavy drinking - 6-month follow-up
|
20.2 percentage of days
Interval 11.9 to 28.5
|
19.9 percentage of days
Interval 12.1 to 27.6
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days abstinent - baseline
|
34.3 percentage of days
Interval 27.1 to 41.6
|
31.2 percentage of days
Interval 23.5 to 38.8
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days abstinent - After treatment
|
67.5 percentage of days
Interval 58.9 to 76.1
|
63.1 percentage of days
Interval 54.9 to 71.4
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days abstinent - 3-month follow up
|
65.6 percentage of days
Interval 57.0 to 74.2
|
68.4 percentage of days
Interval 59.3 to 77.4
|
|
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
% Days abstinent - 6-month follow-up
|
66.2 percentage of days
Interval 56.5 to 75.9
|
64.0 percentage of days
Interval 54.8 to 73.3
|
Adverse Events
Arm 1: Integrated Prolonged Exposure Therapy
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Seeking Safety
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Integrated Prolonged Exposure Therapy
n=63 participants at risk
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
|
Arm 2: Seeking Safety
n=56 participants at risk
Seeking Safety
Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
|
|---|---|---|
|
Psychiatric disorders
hospitalization for alcohol intoxication and mood stabilization
|
3.2%
2/63 • Number of events 2 • Four years and seven months
|
0.00%
0/56 • Four years and seven months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place