The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Adolescents : a Pilot Study

NCT ID: NCT06403449

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2024-10-15

Brief Summary

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The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (G-WET) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 40 participants, with 20 randomized to the G-WET group and 20 randomized to the waiting list (WL) group. The G-WET intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.

Detailed Description

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Randomization was conducted by an independent research assistant, and the random sequence was concealed from the investigator until the process was completed.

Study Groups

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G-WET

Group Type EXPERIMENTAL

Group-delivered guided written exposure therapy-revised version

Intervention Type BEHAVIORAL

Group-Delivered guided WET-R (G-WET) is a manualized exposure-based therapy program consisting of 5-8 sequential sessions. The interval between every 2 consecutive sessions is 0-2 days. There will be 5-8 group-delivered sessions in total (only one index trauma will be discussed), and 1-2 weeks to complete.The first and last sessions are scheduled to last for 1.5 hours each, while the other sessions will be 50 minutes in duration.

Waiting-List (WL) condition

Group Type OTHER

Waiting-List (WL) condition

Intervention Type BEHAVIORAL

Participants assigned to WL will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the 2-week WL period. After the one-month follow-up of the WET-R group, they will receive the same treatment (Group-Delivered guided written exposure therapy-revised version).WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.

Interventions

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Group-delivered guided written exposure therapy-revised version

Group-Delivered guided WET-R (G-WET) is a manualized exposure-based therapy program consisting of 5-8 sequential sessions. The interval between every 2 consecutive sessions is 0-2 days. There will be 5-8 group-delivered sessions in total (only one index trauma will be discussed), and 1-2 weeks to complete.The first and last sessions are scheduled to last for 1.5 hours each, while the other sessions will be 50 minutes in duration.

Intervention Type BEHAVIORAL

Waiting-List (WL) condition

Participants assigned to WL will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the 2-week WL period. After the one-month follow-up of the WET-R group, they will receive the same treatment (Group-Delivered guided written exposure therapy-revised version).WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adolescents aged 10-18 years.
2. Meeting full or subthreshold PTSD (up to one symptom missing) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
4. Capable of writing and understanding written instructions.

Exclusion Criteria

1. Presence of severe psychopathology necessitating immediate medical attention
2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future)
3. Evidence of a moderate or severe traumatic brain injury
4. Currently undergoing psychotherapy specifically for PTSD.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Yinyin Zang, PhD

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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G-WET on Adolescents PTSD

Identifier Type: -

Identifier Source: org_study_id