Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD

February 7, 2023 updated by: Stefan G. Hofmann, Boston University Charles River Campus
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Center for Anxiety and Related Disorders at Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult outpatients ≥ 18 years of age, who have experienced a traumatic event such as sexual assault, physical assualt, a serious accident, or other event where they feared for their life or their safety, at least 3 months prior to intake, with a primary subclinical psychiatric diagnosis of post-traumatic stress disorder (PTSD) as measured by the CAPS-5 (structured clinical interview to assess for PTSD according to the DSM-5). Eligible participants will have a CAPS-5 score of mild or moderate.
  • Physical examination and laboratory findings within normal limits, as determined by the study nurse.
  • Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.
  • Potential subjects must have sufficient command of the English language.

Exclusion Criteria:

  • A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or organic brain syndrome; past history of reported or current seizures; use of Isoniazid (a particular antibiotic); cognitive dysfunction that can interfere with capacity to engage in therapy;
  • A history of substance or alcohol dependence (other than nicotine) in the last 6 months (or otherwise unable to commit to refraining from alcohol use during the acute period of study participation). The acute period of study participation is defined as during their visit and 24 hours before and after their visit.
  • Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  • Patients cannot be taking psychotropic medication during the study period. They have to be off psychotropic medication for three weeks.
  • Participating in ongoing exposure-based psychotherapy for PTSD or psychodynamic therapy focusing on exploring specific, dynamic causes of the traumatic symptomatology and providing management skills. General supportive therapy initiated > 3 months prior to study is acceptable.
  • Significant personality dysfunction likely to interfere with study participation. For example, overly aggressive behavior or disruptive behavior that might jeopardize safety of the staff or impairs providing the treatment.
  • Serious medical illness or instability for which hospitalization may be likely within the next year. For example, if people are currently in a treatment for cancer, or people that are waiting for organ donation. This decision would be determined by our medical staff during the eligibility screen.
  • Patients with a current or past history of epilepsy or seizures.
  • Patients who have experienced any cardiac event. Patients with clinically significant abnormalities in vital signs (e.g., systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg) at screening will be excluded from further study participation and referred for appropriate clinical management.
  • Pregnant women, lactating women, women who are breastfeeding and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, or implanted progesterone rods stabilized for at least 3 months).
  • Patients with a history of head trauma causing loss of consciousness, or ongoing cognitive impairment.
  • Patients who experienced multiple events of interpersonal trauma prior to the age of 14.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBT + ImRs + DCS pill
The experimental arm involves cognitive-behavioral therapy, imagery rescripting techniques and d-cycloserine medication (pill).
Behavioral: CBT + ImRs
Cognitive Behavioral Therapy with Imagery Rescripting
Other Names:
  • Experimental Group
Drug: D-Cycloserine
250 mg DCS (derived from Seromycin 250 mg capsules)
Other Names:
  • Experimental Group
ACTIVE_COMPARATOR: CBT + ImRs + placebo
The active comparator arm involves cognitive behavioral therapy, imagery rescripting techniques and placebo medication (pill).
Behavioral: CBT + ImRs
Cognitive Behavioral Therapy with Imagery Rescripting
Other Names:
  • Experimental Group
Drug: Placebo
polyethylene glycol 3350 powder
Other Names:
  • Active Comparison Group
  • Placebo Comparison Group
ACTIVE_COMPARATOR: CBT + I.E. + study pill
The placebo comparator involves cognitive behavioral therapy, imaginal exposure and study pill (DCS or placebo)
Behavioral: CBT + I.E.
Cognitive Behavioral Therapy with Imagery Exposure
Other Names:
  • Active Comparison Group
Drug: Study Pill
250 mg DCS (derived from Seromycin 250 mg capsules) or polyethylene glycol 3350 powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Clinician-Administered PTSD Scale (CAPS)
Time Frame: Change from baseline to 4 weeks (post-treatment)
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)
Change from baseline to 4 weeks (post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
The PCL-5 is a self-reported measure of PTSD symptom severity. It will also be administered every session during treatment (weeks
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)
Time Frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
The DASS is a self-reported measure of depression, anxiety and stress. It will also be administered before every therapy session.
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)
Time Frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
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.
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)
Time Frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1-month follow-up)
The PSQI measures various domains of sleep quality over the past month
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
Time Frame: Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1-month follow-up)
The Q-LES-Q measures various domains of quality of life and life satisfaction
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
Time Frame: Changes from baseline to 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)
The CAPS is a semi-structured interview that assesses PTSD symptom severity.
Changes from baseline to 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Collaborators

James S McDonnell Foundation

Investigators

  • Study Chair: Joseph K Carpenter, M.A., Boston University
  • Study Chair: Megan Pinaire, B.S., Boston Universtiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

July 12, 2017

First Posted (ACTUAL)

July 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PTSD

Clinical Trials on CBT + ImRs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe