Adaptation and Randomized Controlled Trial of Written Exposure Therapy for Adolescents

NCT07498257 | Active Not Recruiting DMC

• 1 other identifier: Pro00149514
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Written Exposure Therapy (WET) is a five-session mental health therapy for posttraumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and formally tested in individual therapy with people aged 12 to 18. The present study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, interviews will be conducted with PTSD experts and people aged 12 to 18 to learn what changes would help to make WET more suitable for young people. Next, WET will be delivered to five people aged 12 to 18 (using the WET manual as it is written for people over the age of 18) to obtain feedback about what changes should be made to better meet the needs of this age group. In the next part of the study, 48 adolescents aged 12 to 18 who have symptoms of PTSD will be recruited from an integrated pediatric primary clinic (PPC). Youth and caregivers who agree to participate will be randomized (like the flip of a coin) to either receive the adapted version of WET or to receive our current, gold-standard PTSD treatment: Trauma-Focused Cognitive Behavior Therapy (TF-CBT). Participants assigned to receive adapted WET will take part in five to seven weekly therapy sessions. Participants assigned to receive TF-CBT will take part in 12 to 16 weekly therapy sessions. Participants assigned to both groups will complete five study visits: one before therapy and four follow up assessments at 6-weeks, 10-weeks, 20-weeks, and 30-weeks after starting therapy. The purpose of the study visits occurring over a 30-week time period is to better understand how mental health symptoms and diagnoses may change over time following therapy engagement. All therapy and study visits can be completed remotely or in person, per the participant's preference. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Ultimately, it is hoped that the results of the study will help inform efforts to increase access to treatment for posttraumatic stress disorder among young people.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Adolescents; Mental Health

Outcome Measures

Primary Outcomes (8)

• University of California- Los Angeles Posttraumatic Stress Disorder Reaction Index

  The University of California- Los Angeles Posttraumatic Stress Disorder Reaction Index (adolescent and caregiver versions), which are psychometrically strong tools to assess PTSD diagnosis among adolescents, will be administered. Total scores on this measure range from 0 to 108; scores of 35 or higher indicate high likelihood that individuals meet posttraumatic stress disorder (PTSD) diagnostic criteria. Higher scores indicate greater likelihood of meeting diagnostic criteria for PTSD.

  Baseline, 6-, 10-, 20-, and 30-week follow up.

• Child and Adolescent Trauma Screen 2.0

  The Child and Adolescent Trauma Screen (CATS) youth and caregiver reports (ages 7-17) assess exposure to 15 different types of potentially traumatic events followed by 20-items assessing PTSD symptoms. It is a widely used psychometrically validated tool and will be used to assess the adolescent's trauma exposure history and PTSD symptoms per self and caregiver report. Total scores on this measure range from 0 to 60; scores of 21 or higher indicate elevated symptoms of posttraumatic stress disorder (PTSD). Higher scores indicate greater PTSD symptoms.

  Baseline, 6-, 10-, 20-, and 30-week follow up

• Cognitive Emotion Regulation Questionnaire- Short (CERQ - Short)

  The Cognitive Emotion Regulation Questionnaire - Short is an 18-item psychometrically validated measure of emotion regulation strategies and has been used widely with trauma exposed adolescents. The rumination subscale of the CERQ will be used to examine changes in ruminative thinking, a proposed mechanism of WET's action to be tested in the study, over the course of treatment. Total scores on this measure range from 18 to 90. Several subscales are included on this measure: Self-blame, Other-blame, Rumination, Catastrophizing, Putting into perspective, Positive refocusing, Positive reappraisal, Acceptance, and Planning Higher scores indicate higher levels of experiencing each symptom area measured (e.g., higher scores on the self blame subscale indicate greater self-blame; higher scales on the positive re-focusing indicate greater ability to positively refocus).

  Baseline, 6-, 10-, 20-, and 30-week follow up

• Acceptability of Intervention Measure

  The Acceptability of Intervention Measure is a 4-item measure used to assess patient perceptions of new interventions, including whether they believe the new treatment is agreeable, palatable, or satisfactory on a five-point Likert scale. This measure will be administered to adolescents and their caregivers to gauge acceptability of the experimental intervention for meeting the needs of the adolescent population. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater acceptability of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).

  6-, 10-, 20-, and 30-week follow up

• Feasibility of Intervention Measure

  The Feasibility of Intervention Measure is a 4-item measure to assess perceptions of whether an intervention will be able to be successfully implemented within a given agency or setting to a certain population of interest. This measure will be administered to adolescents and caregivers to gauge perceptions of feasibility of WET for delivery with adolescents. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater perceived feasibility of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).

  6-, 10-, 20-, and 30-week follow up

• Client Satisfaction Questionnaire - 8 item

  The Client Satisfaction Questionnaire (8 item) measure examines satisfaction with treatment services on an 8-item Likert scale to assess perceptions of satisfaction following treatment services. It has been used among adolescent and caregiver populations and has strong psychometric properties. Total scores on this measure range from 8 to 32. Higher scores indicate greater satisfaction with the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).

  6-week follow up (WET condition) and 20-week follow up (TF-CBT condition)

• Subjective Units of Distress

  As part of WET, Subjective Units of Distress (SUDS) are verbally reported to examine current emotional arousal in response to exposure. Participants are prompted by the therapist to indicate level of emotional arousal on a scale of 0-100 before and following writing. Higher scores indicate greater levels of distress. Therapists will document reported SUDS weekly.

  Weekly Sessions

• Semi-Structured Interview

  Questions will include probes about how to enhance the intervention to elicit impressions of the un-adapted content (e.g., written prompt wording, relevance of psychoeducational content, helpfulness), areas in need of adaptation, gaps missing in the manual, and recommendations for adaptations (e.g., wording alterations, content adaptations). Interviews will also inquire about barriers and facilitators to traditional trauma-focused treatment and whether WET meets or does not meet priorities and needs of adolescents with PTSD and their caregivers.

  6 week follow up (WET condition only)

Secondary Outcomes (2)

• Mini-International Neuropsychiatric Interview for Children and Adolescents

  Baseline, 6-, 10-, 20-, and 30-week follow up

• Revised Children's Anxiety and Depression Scale

  Baseline, 6-, 10-, 20-, and 30-week follow up

Study Arms (2)

Experimental Group (Written Exposure Therapy)

EXPERIMENTAL

Behavioral: Written Exposure Therapy

Comparison Condition (Trauma-focused Cognitive Behavior Therapy)

ACTIVE COMPARATOR

Behavioral: Trauma-focused Cognitive Behavior Therapy

Interventions

Written Exposure Therapy BEHAVIORAL

Written Exposure Therapy (WET) is an evidence-based treatment (EBT) for PTSD among adults that involves five 45-60 minute sessions. WET is non-inferior to gold-standard EBTs including Cognitive Processing Therapy and Prolonged Exposure. Each session involves 30-minutes writing following focused prompts that include recalling details of the traumatic event as well as related cognitions and emotions. Session one also includes providing psychoeducation about posttraumatic stress disorder and the rationale for exposure. Between sessions, the therapist reads the writing and prepares feedback. The intervention will be delivered during five, consecutive weekly 45-60-minute sessions to participants assigned to the experimental WET condition.

Experimental Group (Written Exposure Therapy)

Trauma-focused Cognitive Behavior Therapy BEHAVIORAL

Trauma-focused cognitive behavior therapy (TF-CBT) is the gold-standard EBT for adolescents with PTSD and is comprised of three phases: safety and stabilization, gradual exposure, and consolidation/integration. The safety and stabilization phase includes psychoeducation, parenting skills training, and building coping skills. The gradual exposure phase involves helping the youth describe a detailed narrative of the traumatic event(s) and craft an in vivo hierarchy of trauma-related feared, but objectively safe, stimuli to face in a gradual fashion. During the final consolidation/integration phase, a conjoint caregiver-child session in which the child shares their trauma narrative with a caregiver occurs and youth are taught skills and education to enhance future safety. Youth randomized to TF-CBT will receive 12-16 consecutive 60-minute weekly sessions following the manual.

Comparison Condition (Trauma-focused Cognitive Behavior Therapy)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 12 through 18 years old. 18-year-old participants who turn 18 after the date in which they consent to participate may participate, but may not enroll in the study if already at the age of 19.
• Accompanying, consenting caregiver (exception, 18-year-olds can provide consent without accompanying caregiver)
• Exposure to one or more potentially traumatic event(s) on the NCVTRC clinic phone screen.
• Ability to comprehend English.
• A score of greater than or equal to 6 on the Child Trauma Screen (CTS)
• Residence in the state of South Carolina.

You may not qualify if:

• Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
• Active suicide risk with ideation, plan and intent.
• Active, ongoing violence, abuse, or other ongoing traumatic events that indicate immediate safety concerns.
• Children in foster care, kinship care, or with active Department of Social Services (DSS) investigations.
• History of pervasive developmental or intellectual disability.
• Any other medical or psychiatric condition that compromise the participant's ability to safely participate.
• Inability or unwillingness of the caregiver to consent for adolescent to participate (exception, 18-year-olds can provide consent without accompanying caregiver).
• Masters-level degree or higher in psychology or a related discipline (e.g., social work; counseling).
• Current provider of trauma-focused treatment to adolescents with PTSD in an outpatient setting for a minimum of one year.
• Ability to comprehend English.
• Consent to participate in a one time study visit.
• Masters-level degree or higher in psychology or a related discipline (e.g., social work; counseling).
• Current status as a mental health clinician housed in an integrated pediatric primary care setting.
• Ability to comprehend English.
• Consent to participate in a one-time study visit.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina National Crime Victims Research and Treatment Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor-Faculty

Model Details: Participants (n=48) in the Randomized Controlled Trial (RCT) will be randomized in a 2:1 fashion to either the experimental group (Written Exposure Therapy; n=32) or the comparison condition (Trauma-focused Cognitive Behavior Therapy; n = 16).

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)