The Effectiveness of Written Exposure Therapy for PTSD

NCT05421494 | Recruiting

• 1 other identifier: WET-R for PTSD
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Study 1: The goal of this study is to use a pilot RCT to assess the effectiveness of Written Exposure Therapy (WET) and a mindfulness-based app (MBA) for managing PTSD and comorbid insomnia in China. The main questions it aims to answer are:

1. 1.Does WET alone reduce PTSD symptoms in Chinese patients with PTSD and subthreshold PTSD?
2. 2.Does the addition of MBA to WET lead to greater reductions in comorbid insomnia symptoms compared to WET alone?

Conditions

PTSD; Subclinical PTSD

Keywords

PTSD; written exposure therapy; randomized controlled trial; online intervention; online psychotherapy

Outcome Measures

Primary Outcomes (5)

• study 2: 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

• study 2: 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

• study 2: 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

• study 2: 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

• study 1: PTSD symptom severity

  The reduction in PTSD symptoms will be measured using the PTSD Symptom Scale, Interview Version for DSM-5 (PSSI-5). This clinician-administered interview assesses the frequency and severity of PTSD symptoms using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).

  Assessed at baseline, immediately post-treatment, and at 3-month follow-up periods.

Secondary Outcomes (1)

• study 1: Insomnia Severity

  Insomnia severity is assessed at baseline, weekly during the 5-week treatment period, and at the immediate post-treatment, and 3-month follow-up assessments.

Study Arms (5)

study2: WET-R

EXPERIMENTAL

Behavioral: written exposure therapy-revised version

study 2: MCC

PLACEBO COMPARATOR

Behavioral: minimal contact control

study 1: WET

EXPERIMENTAL

Written Exposure Therapy (WET) is a manualized exposure-based therapy involving five sequential weekly individual sessions. Each session lasts approximately 40 minutes except the first, which is one hour. In the initial session, the therapist explains the treatment rationale and guides the participant to write about their traumatic experience uninterrupted for 30 minutes. Subsequent sessions start with a brief discussion about the previous session's writing, followed by another 30-minute writing session, concluding with a short check-in. There is no homework between sessions.

Behavioral: written exposure therapy-revised version

study 1: WET+MBA

EXPERIMENTAL

WET + MBA combines the standard WET protocol with the addition of a mindfulness practice facilitated through a mobile app called "Now Meditation." This app is among the most downloaded mindfulness apps in China, used to help manage symptoms of insomnia commonly comorbid with PTSD. Participants are instructed to engage in daily mindfulness exercises according to the app's "7-Day Basic Meditation" program and continue practicing mindfulness throughout the duration of the therapy. This is intended to supplement the therapeutic effects of WET by providing tools to manage insomnia and potentially enhancing the therapeutic process by fostering greater mindfulness and relaxation.

Behavioral: written exposure therapy-revised version

study 1: MCC

PLACEBO COMPARATOR

MCC contains weekly phone calls from a study therapist to monitor their status and provide support as needed, without introducing any specific therapeutic interventions. These calls are brief, generally lasting between 10 to 15 minutes, and are strictly for the purpose of engagement and safety monitoring rather than therapeutic intervention.

Behavioral: minimal contact control

Interventions

written exposure therapy-revised version BEHAVIORAL

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.

study 1: WET; study 1: WET+MBA; study2: WET-R

minimal contact control BEHAVIORAL

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.

study 1: MCC; study 2: MCC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female aged between 18-65 years old; A diagnosis of PTSD or subthreshold PTSD (PTSD Symptom Scale, Interview Version for DSM-5, PSSI-5); If currently taking psychotropic medication, taking a stable one for at least 4 weeks; A smartphone owner and no obstacle to the Now Meditation App; Scoring 12 or more on Insomnia Severity Index (ISI; the symptoms appear after the diagnosis of full/subthreshold PTSD).

You may not qualify if:

• A diagnosis of bipolar disorder or psychotic disorder; Current substance dependence; Evidence of a moderate or severe traumatic brain injury (as determined by the obstacle to comprehending the baseline screening questionnaires); Serious suicidal ideation (as determined by the Scale for Suicidal Ideation); Other psychiatric disorders severe enough to warrant designation as the primary disorder; Taking psychotherapy for PTSD currently.
• Study 2:
• Adult male and female (aged between 18-65 years old)
• 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)
• If currently taking psychotropic medication, taking a stable one for at least 4 weeks
• Having the ability to write and comprehend the writing guidelines
• A diagnosis of bipolar disorder or psychotic disorder
• Current substance dependence
• Evidence of a moderate or severe traumatic brain injury (as determined by the obstacle to comprehending the screening questionnaires)
• Serious suicidal ideation (as determined by the MINI interview)
• Taking psychotherapy for PTSD currently

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Yinyin Zang, PhD

CONTACT

+86 15553201610; yinyin.zang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 16, 2022
• Study Start: June 15, 2022
• Primary Completion: June 10, 2024
• Study Completion: December 10, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

CN (1)