Study protocol: A multimethod psychophysiological randomized controlled trial of a couple therapy for post-traumatic stress disorder

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Abstract

Posttraumatic stress disorder (PTSD) sequelae often have ripple effects on victims' families and spouses. Yet there has been a lag in the development and study of couple therapy for PTSD. To fill this gap, we present here a protocol for a study examining the efficacy of Cognitive Behavioral Conjoint Therapy (CBCT), a 15- session couple therapy protocol meant to alleviate PTSD and improve relationship satisfaction, in the Israeli context. The study will be a randomized controlled trial examining outcomes and processes of change via self-report questionnaires, qualitative interviews, and physiological measures (e.g., both partners' heart rate variability and electrodermal activity). We will employ a modified remote treatment protocol via video conferencing. The study will examine whether there is a reduction in couples' levels of symptomatic, emotional, and behavioral difficulties following CBCT and whether relationship satisfaction and couples' physiological synchrony increases. The study will also examine physiological and psychological change mechanisms in CBCT. Sixty Israeli couples (n = 120) will be randomly assigned to either a CBCT group or a wait-list control group. Outcomes will be assessed at four timepoints: before treatment, during treatment, post-treatment, and four months after treatment. The proposed study has the potential to shed light on the unique psychological and physiological mechanisms underlying CBCT and will be the first RCT study to employ this unique methodology in CBCT research, particularly in a video conferencing setting. This study may increase our ability to offer effective, cost-efficient, and attainable treatments for patients with PTSD and their spouses.

Original languageEnglish
Article number107280
JournalContemporary Clinical Trials
Volume132
DOIs
StatePublished - Sep 2023

Bibliographical note

Publisher Copyright:
© 2023 Elsevier Inc.

Funding

This study will be carried out in accordance with The Declaration of Helsinki. The study will be funded by the Israel Science Foundation (ISF), grant number 2326/20 and is registered with the National Institute of Health (NIH) (ID: NCT05045859 ). The participants will all sign an informed consent form and a confidentiality waiver. By signing these forms, the participants will be allowing for the recording of the therapy sessions for purposes of training and fidelity assessment. In the event of high psychological distress, immediate suicidal risk, psychosis, or significant relationship violence, an experienced staff member will talk to the couples to better understand the distress, refer them to an appropriate mental health provider, and ask to speak with the referring therapist if there is one, or the family doctor for updating.

FundersFunder number
National Institutes of HealthNCT05045859
Israel Science Foundation2326/20

    Keywords

    • #PTSD
    • Autonomic nervous system
    • Couples therapy
    • Physiological synchrony
    • Randomized controlled trial
    • Telepsychology

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