PTSD
Conditions
Keywords
PTSD, mindfulness meditation, cognitive behavior therapy, relationship function, couple therapy
Brief summary
The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with PTSD and their intimate partners by (1) reducing the overall length of treatment from 15 weeks to 10 weeks through the use of a weekend couple retreat to deliver the first two of three phases of the three-phase protocol; and (2) by integrating mindfulness interventions as a way to mitigate the short, more condensed treatment. Secondly, this study will examine the effects of this adapted Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD symptoms and intimate relationship functioning.
Detailed description
Between 5 and 15 percent of Veterans return from deployment in Iraq and Afghanistan with PTSD and the symptoms adversely affect many aspects of their lives, including intimate relationships. Although research findings consistently suggest that the degree of intimate relationship dysfunction correlates with the severity of Veteran's PTSD symptoms, few couples interventions have been developed and systematically evaluated. Cognitive Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) is an intervention developed to treat both PTSD and relationship dysfunction that has shown promising preliminary results. However, the literature suggests that OEF-OIF Veterans prefer shorter time-limited treatments and CBCT for PTSD requires as many as 15 sessions. CBCT for PTSD lacks specific interventions that train meta-awareness, such as those taught in mindfulness-based stress reduction (MBSR). Mindfulness practices have an emerging evidence base for improving both PTSD and relationship functioning in several important ways. First, practicing mindfulness promotes the relaxation response which counters hyperarousal and results in a calmer approach to difficulties and challenges. Second, avoidance and numbing are countered by mindfully allowing one's experience to be as it is while suspending judgment, which is associated with increased compassion and empathy. Lastly, mindfulness supports a way of being with all life experiences rather than providing techniques just for coping with specific difficulties, which enables individuals to access inner strengths that are already available to them. Just as many physical conditions require more than one rehabilitation approach, there may be a synergy between CBCT for PTSD and mindfulness interventions. Mindfulness skills may assist individuals in tolerating painful emotional reactions to their experiences which may in turn enhance their awareness of associated feelings and thoughts. With enhanced meta-awareness the beliefs that may maintain PTSD symptoms and relationship dysfunction become more amenable to cognitive restructuring. Therefore, the goal of this study is to examine the effects of a Mindfulness-Based adaptation of CBCT for PTSD. The study involves two phases over the course of four years. In Phase 1, mindfulness interventions will be integrated within the Cognitive Behavioral Conjoint Therapy for PTSD treatment manual and the content of the first 7 sessions of CBCT will be adapted to be delivered during a weekend retreat. The integrated intervention, MB-CBCT for PTSD, will be delivered to 10 OIF-OEF Veterans and each of their intimate partners in order to develop and test procedures to train and monitor therapists. During Phase 2, 40 OEF-OIF Veterans and each of their intimate partners will be consented and a randomized controlled trial with be conducted comparing the MB-CBCT for PTSD with a control condition that teaches communication skills drawn from the first 7 sessions of the CBCT manual. We hypothesize that MB-CBCT for PTSD will lead to greater improvement in: 1) Veterans' PTSD symptoms as measured by the Clinician Administered PTSD Scale (primary outcome) and PTSD Checklist (secondary outcome); 2) Veterans' and partners' relationship functioning (secondary outcome); and 3) anxiety and depression symptoms (secondary outcomes). PTSD constitutes a substantial proportion of the burden of illness among Veterans. The longer term goals of this project are to conduct a fully-powered randomized controlled clinical trial of MB-CBCT to determine its effectiveness and to finalize the treatment manual.
Interventions
BEHAVIORALMindfulness Based Cognitive Behavioral Conjoint Therapy
This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication 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.
BEHAVIORALCBCT for PTSD - Communication Skills
This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veteran must: * be enrolled in outpatient treatment * have a confirmed diagnosis of PTSD * have no major change in psychiatric medication for at least 1 month * have a partner mutually committed to maintaining the relationship for the duration of the intervention * willing to forgo initiating psychotherapy for PTSD or other conditions during the study
Exclusion criteria
* severe physical or sexual relationship aggression in the past year * current suicidal/homicidal intent (Veteran or partner) * cognitive impairment that precludes understanding session content (either Veteran or partner) * current substance dependence of Veteran or partner * uncontrolled psychotic or bipolar disorder in Veteran or partner * PTSD diagnosis in the partner * self-mutilation or self-injury within the previous 6 months by Veteran or partner * unwilling to have therapy or CAPS sessions video or audio recorded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | treatment end (approximately 10 weeks after session 1 of the interventions) | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Cognitive-Behavioral Conjoint Therapy 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. | 23 |
| Cognitive Behavioral Conjoint Therapy Communication Skills 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. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Conjoint Therapy Communication Skills | Mindfulness-Based Cognitive-Behavioral Conjoint Therapy | Total |
|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 11.3 | 38.9 years STANDARD_DEVIATION 9.2 | 39.9 years STANDARD_DEVIATION 10.3 |
| Beck Depression Inventory II (BDI) | 26.8 units on a scale STANDARD_DEVIATION 9.6 | 25.6 units on a scale STANDARD_DEVIATION 9.5 | 26.2 units on a scale STANDARD_DEVIATION 9.5 |
| Clinician Administered PTSD Scale (CAPS) | 70.4 units on a scale STANDARD_DEVIATION 13.9 | 71.1 units on a scale STANDARD_DEVIATION 12.4 | 70.7 units on a scale STANDARD_DEVIATION 13.1 |
| Dyadic Adjustment Scale (DAS) | 96.0 units on a scale STANDARD_DEVIATION 25 | 99.7 units on a scale STANDARD_DEVIATION 19.2 | 97.9 units on a scale STANDARD_DEVIATION 22.1 |
| PTSD Checklist (PCL) | 57.2 units on a scale STANDARD_DEVIATION 10.5 | 57.6 units on a scale STANDARD_DEVIATION 7.8 | 57.4 units on a scale STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
| State-Trait Anxiety Inventory State Subscale | 49.8 units on a scale STANDARD_DEVIATION 12.7 | 51.9 units on a scale STANDARD_DEVIATION 8.3 | 50.9 units on a scale STANDARD_DEVIATION 10.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
Clinician-Administered PTSD Scale (CAPS)
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Mindfulness-Based Cognitive-Behavioral Conjoint Therapy | Clinician-Administered PTSD Scale (CAPS) | 45.5 units on a scale |
| Cognitive Behavioral Conjoint Therapy Communication Skills | Clinician-Administered PTSD Scale (CAPS) | 46.2 units on a scale |
Comparison: We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.p-value: 0.84995% CI: [-1.39, 13.2]Mixed Models Analysis