Trial Outcomes & Findings for Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function (NCT NCT01035788)
NCT ID: NCT01035788
Last Updated: 2018-11-01
Results Overview
The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.
COMPLETED
NA
92 participants
treatment end (approximately 10 weeks after session 1 of the interventions)
2018-11-01
Participant Flow
88 couples (88 Veterans \& their 88 intimate partners) were consented \& 78 couples completed eligibility screening. 32 couples were excluded (not meeting inclusion/exclusion criteria; met criteria but declined to proceed, or unable to attend required retreat weekend. The remaining 46 couples were randomized (46 Veterans \& 46 partners).
Participant milestones
| Measure |
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
|
Cognitive Behavioral Conjoint Therapy Communication Skills
Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
17
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy
n=23 Participants
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses.
|
Cognitive Behavioral Conjoint Therapy Communication Skills
n=23 Participants
Psychoeducational Intervention
Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Dyadic Adjustment Scale (DAS)
|
99.7 units on a scale
STANDARD_DEVIATION 19.2 • n=5 Participants
|
96.0 units on a scale
STANDARD_DEVIATION 25.0 • n=7 Participants
|
97.9 units on a scale
STANDARD_DEVIATION 22.1 • n=5 Participants
|
|
Beck Depression Inventory II (BDI)
|
25.6 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 9.6 • n=7 Participants
|
26.2 units on a scale
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Clinician Administered PTSD Scale (CAPS)
|
71.1 units on a scale
STANDARD_DEVIATION 12.4 • n=5 Participants
|
70.4 units on a scale
STANDARD_DEVIATION 13.9 • n=7 Participants
|
70.7 units on a scale
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
PTSD Checklist (PCL)
|
57.6 units on a scale
STANDARD_DEVIATION 7.8 • n=5 Participants
|
57.2 units on a scale
STANDARD_DEVIATION 10.5 • n=7 Participants
|
57.4 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
State-Trait Anxiety Inventory State Subscale
|
51.9 units on a scale
STANDARD_DEVIATION 8.3 • n=5 Participants
|
49.8 units on a scale
STANDARD_DEVIATION 12.7 • n=7 Participants
|
50.9 units on a scale
STANDARD_DEVIATION 10.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: treatment end (approximately 10 weeks after session 1 of the interventions)Population: This analysis was intention to treat and included the 30 participants of the original 34 who completed the CAPS interview at treatment end.
The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.
Outcome measures
| Measure |
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy
n=19 Participants
Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD
This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses.
|
Cognitive Behavioral Conjoint Therapy Communication Skills
n=11 Participants
Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills
This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD.
|
|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
45.5 units on a scale
Interval 36.6 to 54.5
|
46.2 units on a scale
Interval 34.9 to 57.5
|
Adverse Events
Mindfulness-Based Cognitive-Behavioral Conjoint Therapy
Cognitive Behavioral Conjoint Therapy Communication Skills
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place