The Effectiveness of Online Revised Written Exposure Therapy for PTSD

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

written exposure therapy-revised version

minimal contact control

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, written exposure therapy, randomized controlled trial, online intervention, online psychotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Peking UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

WET-R

MCC

Arm Description

Outcomes

Primary Outcome Measures

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).

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).

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05421494

First Posted

June 9, 2022

Last Updated

July 13, 2022

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT05421494

Brief Title

The Effectiveness of Online Revised Written Exposure Therapy for PTSD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

November 10, 2023 (Anticipated)

Study Completion Date

April 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD, Subclinical PTSD

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WET-R

Arm Type

Experimental

Arm Title

MCC

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

written exposure therapy-revised version

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

minimal contact control

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at Posttreatment

Description

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).

Time Frame

3 weeks

Title

Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the First Follow-Up

Description

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).

Time Frame

7 weeks

Title

Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the Second Follow-Up

Description

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).

Time Frame

15 weeks

Title

Change from Baseline of PTSD Symptom Scale, Interview Version for DSM-5(PSSI-5) at the Third Follow-Up

Description

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).

Time Frame

27 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yinyin Zang, PhD

Phone

+86 15553201610

Email

yinyin.zang@pku.edu.cn

Facility Information:

Facility Name

Peking University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100871

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yinyin Zang

Phone

+86-010-62756953

Email

yinyin.zang@pku.edu.cn

First Name & Middle Initial & Last Name & Degree

Yinyin Zang, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

PTSD, Subclinical PTSD

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial