The Effectiveness of Online Revised Written Exposure Therapy for PTSD

PTSD Clinical Trial

Official title:

The Effectiveness of Online Revised Written Exposure Therapy for PTSD: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421494
• Other study ID #: WET-R for PTSD
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 10, 2024

Study information

• Verified date: July 2022
• Source: Peking University
• Contact: Yinyin Zang, PhD
• Phone: +86 15553201610
• Email: yinyin.zang[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to examine the effectiveness of the online revised written exposure therapy (WET-R) for PTSD and subclinical PTSD among Chinese adults with a randomized controlled trial. The study will recruit 90 participants, with 60 randomized to the online WET-R group, and 30 randomized to the minimal contact control (MCC) group. The WET-R intervention consists of 5-7 one to one sessions. The primary outcome PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 10, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Adult male and female (aged between 18-65 years old)

2. A diagnosis of PTSD or subclinical PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5), meeting the following criteria: Meeting full criteria for re-experiencing and at least 2 of 3 other symptom clusters (i.e., avoidance, negative cognitions, or hyperarousal)

3. If currently taking psychotropic medication, taking a stable one for at least 4 weeks

4. Having the ability to write and comprehend the writing guidelines

Exclusion Criteria:

1. A diagnosis of bipolar disorder or psychotic disorder

2. Current substance dependence

3. Evidence of a moderate or severe traumatic brain injury (as determined by the obstacle to comprehending the screening questionnaires)

4. Serious suicidal ideation (as determined by the MINI interview)

5. Taking psychotherapy for PTSD currently

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• written exposure therapy-revised version
WET-R is a manualized exposure-based therapy program consisting of 5-7 sequential individual sessions. The interval between every 2 consecutive sessions is 0-3 days. There will be 5-7 one to one online sessions in total (only one index trauma will be discussed), and 1-3 weeks to complete. Sessions are scheduled to last for 1 hour in the first session and 50 minutes in other sessions.
• minimal contact control
Participants assigned to MCC will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the 3-week MCC period. They will be video-called once per week by a therapist to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MCC participants will also be given contact information to use in case of worsening symptoms or increasing distress.

Locations

Country	Name	City	State
China	Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at Posttreatment	The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).	3 weeks
Primary	Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the First Follow-Up	The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).	7 weeks
Primary	Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the Second Follow-Up	The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).	15 weeks
Primary	Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the Third Follow-Up	The PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5), a 24-item clinician-administered interview, will be used for PTSD diagnosis and measure PTSD symptom severity. The PSSI-5 rates the frequency and severity of PTSD symptoms in the past 4 weeks on a 5-point Likert scale from 0 (not at all) to 4 (very much). The PSSI-5 has demonstrated excellent reliability and validity but takes less time than the gold standard mostly used, the Clinician-Administered PTSD Scale for DSM-5 (CAPS5).	27 weeks