Post-traumatic Stress Disorder Clinical Trial
Official title:
Cognitive-Behavioral Couples Therapy for Posttraumatic Stress Disorder
This study will evaluate the effectiveness of cognitive behavioral couples therapy designed for post-traumatic stress disorder in reducing symptoms of post-traumatic stress disorder and in improving relationship functioning.
Post-traumatic stress disorder (PTSD) is a highly prevalent and disabling disorder that
affects about 7.7 million adults in the United States. PTSD can develop after someone
experiences a particularly distressing event that may involve the threat of or actual
physical harm. Common symptoms of PTSD include avoidance of situations or cues that may act
as reminders of the event, reoccurring flashbacks of the event, loss of interest in
previously enjoyed activities, and numbing of emotions. Additionally, PTSD is often
associated with far-reaching and devastating interpersonal relationship problems that can
maintain or aggravate other PTSD symptoms. These interpersonal problems can also interfere
with successful treatment delivery, so addressing such problems is important for improving
treatment compliance, effectiveness, and long-term success. Cognitive behavioral therapy
(CBT) is a type of psychotherapy that teaches ways to modify thoughts and behaviors that
contribute to PTSD. CBT that is adapted for couples in which one partner has PTSD may be the
most effective means of decreasing individual PTSD symptoms and improving the couple's
relationship. This study will evaluate the effectiveness of cognitive behavioral couples
therapy (CBCT) for PTSD in reducing symptoms of PSTD and in improving relationship
functioning for couples in which one partner has PTSD.
Participation in this study will last 8 months. All participants will undergo baseline
assessments that will include an interview about exposure to traumatic events, PTSD
symptoms, mental health problems, and substance use; self-report questionnaires about mood,
social and leisure activities, and relationships; and a brief video-recorded communication
session as a couple. Eligible participants will then be assigned randomly to receive
immediate CBCT for PTSD or delayed CBCT for PTSD. Participants in the delayed treatment
group will receive active treatment after a 3-month waitlist period. CBCT for PTSD will
include fifteen 75-minute couples therapy sessions, occurring twice weekly for 3 weeks and
weekly for the remaining 9 weeks of treatment. Sessions will follow manual-based couples
therapy and will aim to both decrease individual PTSD symptoms and enhance dyadic
functioning. After each session, participants will also complete out-of-session practice
assignments that will include completing worksheets and practicing skills taught in therapy
sessions.
Participants receiving immediate CBCT for PTSD will undergo subsequent assessments at
mid-treatment, end of treatment, and 3 months after the end of treatment. Participants
receiving delayed treatment will undergo assessments 1 and 3 months into the wait-list
period and at the end of treatment. Assessments will include questions about PTSD and mental
health symptoms, alcohol and substance use, intimate relationship functioning, and family
and social activities. Participants will repeat the communication session after the end of
treatment for the group receiving immediate therapy and at the end of the wait-list period
for the delayed treatment group.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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