This study aims to investigate the utility of d-cycloserine (DCS) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs), in adults with mild to moderate PTSD symptoms after experiencing a traumatic event such as sexual or physical assault, serious accident, etc. Participants will receive 4 sessions of either cognitive behavioral therapy with imagery rescripting or cognitive behavioral therapy with imaginal exposure and will receive study medication (DCS or Pill placebo) prior to Session 2 and Session 3.
The primary aim of this proof-of-concept-study is to investigate the utility of d-cycloserine (DCS; a partial N-methyl-D-aspartate receptor agonist) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs). ImRs is a therapeutic technique that has shown positive outcomes for people suffering from PTSD and as an adjunct to CBT for PTSD. Patients are asked to recall their memory of a specific traumatic experience, and then to imagine an intervention that changes the course and outcome of the event to produce a more satisfying result. It is hypothesized that reconsolidation of the trauma memory is the mechanism of ImRs. DCS augments exposure therapy but also appears to enhance reconsolidation of memory. We hypothesize that DCS will enhance the effect of ImRs by incorporating safety cues into the trauma memory. Sixty adults with PTSD symptoms due to a traumatic event at least three months prior to intake will receive 4 sessions of either: CBT + ImRs, or CBT + imaginal exposure (IE). In sessions 2 and 3, participants will be randomized to receive either DCS or placebo (PLA). We hypothesize that DCS + ImRs sessions will enhance treatment outcome by facilitating reconsolidation of the trauma memories incorporating new safety cues. We also hypothesize that ImRs + PLA will provide equal or better outcomes as the IE + PLA condition. The primary outcome measure will be improvements in PTSD symptoms, as assessed at baseline, post-treatment and at 1-month follow-up. Secondary outcome measures will be self-report questionnaires assessing depression symptoms, general psychological complaints, sleep quality, quality of life, and PTSD cognitions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Cognitive Behavioral Therapy with Imagery Rescripting
Cognitive Behavioral Therapy with Imagery Exposure
250 mg DCS (derived from Seromycin 250 mg capsules)
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, United States
The Clinician-Administered PTSD Scale (CAPS)
The CAPS is a semi-structured interview that assesses PTSD symptom severity. It will also be administered at 1-week and 4-week follow up (see secondary outcomes)
Time frame: Change from baseline to 4 weeks (post-treatment)
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-reported measure of PTSD symptom severity. It will also be administered every session during treatment (weeks
Time frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
Depression, Anxiety and Stress Scale (DASS-21)
The DASS is a self-reported measure of depression, anxiety and stress. It will also be administered before every therapy session.
Time frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
Posttraumatic Cognitions Inventory (PTCI)
The PTCI measures negative cognitions about the self, the world and self-blame related to trauma. It will also be administered at every therapy session.
Time frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI measures various domains of sleep quality over the past month
Time frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1-month follow-up)
Quality of Life Enjoyment and Satisfaction Questionnaire
The Q-LES-Q measures various domains of quality of life and life satisfaction
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polyethylene glycol 3350 powder
250 mg DCS (derived from Seromycin 250 mg capsules) or polyethylene glycol 3350 powder
Time frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1-month follow-up)
The Clinician-Administered PTSD Scale (CAPS) at follow-up
The CAPS is a semi-structured interview that assesses PTSD symptom severity.
Time frame: Changes from baseline to 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)