Efficacy of Internet-delivered Trauma-focused CBT for Young People With PTSD

NCT06185244 | Recruiting

• 1 other identifier: 2023-06501-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare therapist-guided internet delivered trauma-focused cognitive behavior therapy (CBT) to an active control condition comprising therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques and psychoeducation for young people with post-traumatic stress disorder regarding efficacy and cost effectiveness. Young people with post-traumatic stress disorder will be randomly assigned to receive either 12 weeks of therapist-guided internet delivered trauma-focused cognitive behavior therapy (iTF-CBT) or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation and psychoeducation.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; digital treatment; trauma-focused CBT; therapist-guided

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale Children and Adolescent version 5 (CAPS-5-CA)

  The CAPS-5-CA is a structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.

  Baseline, 1-month (primary endpoint), 6-month and 12-month after treatment completion

Secondary Outcomes (14)

• Change in self-rated symptoms of PTSD and complex PTSD measured by The Child and Adolescent Trauma Screen (CATS-2)

  Baseline, through the treatment period up to 12 weeks and 1-month, 6-month and 12-month after treatment completion

• Change in self-rated symptoms of depression as measured by Mood and Feelings Questionnaire (MFQ)

  Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion

• Change in psychosocial impairment measured by The Education, Work and Social Adjustment Scale, Youth and Parent (EWSAS)

  Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion

• Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)

  Baseline, immediately after treatment completion, and 1-month, 6-month and 12-month after treatment completion

• Adverse events related to treatment measured by the Negative effects questionnaire

  Immediately after treatment completion, 1-month, 6-month and 12-month after treatment completion

Other Outcomes (2)

• Differences in treatment credibility between arms

  After completion of the first treatment module (week 1 from baseline)

• Differences in experience of working alliance between arms

  After completion of the third module (week 3 from baseline)

Study Arms (2)

Therapist-supported internet delivered trauma-focused CBT

EXPERIMENTAL

Therapist-supported internet delivered trauma-focused CBT. The protocol mirrors the exact content of first-line treatment for children with PTSD but is delivered through a digital platform and will comprise of text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially. iTF-CBT will be therapist-assisted, and each participant will have a designated therapist to guide them through treatment. Treatment will span over 12 weeks and integrates cognitive, behavioral, interpersonal, and family therapy principles as well as trauma interventions. Parallel to the child's treatment, the caregivers are provided the same components and parenting practices, and joint child-parent activities are included. Participants will have access to a therapist that will guide them through treatment in a text based format.

Behavioral: Therapist-supported internet-delivered trauma-focused CBT

Therapist-supported psychoeducation and stress management

ACTIVE COMPARATOR

Therapist-supported CBT internet-delivered treatment comprising psychoeducation about PTSD, relaxation/stress management techniques and relapse prevention. The treatment will be delivered in a digital platform for twelve weeks. Participants will have access to a therapist that will guide them through treatment in a text-based material as well as audio files and video illustrations in an age-appropriate manner that the participant gains access to sequentially.

Behavioral: 12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.

Interventions

Therapist-supported internet-delivered trauma-focused CBT BEHAVIORAL

12 weeks of therapist-supported internet-delivered trauma-focused CBT for both the youth and the care giver.

Therapist-supported internet delivered trauma-focused CBT

12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver. BEHAVIORAL

12 weeks of therapist-supported internet-delivered psychoeducation and stress management/relaxation for both the youth and the care giver.

Therapist-supported psychoeducation and stress management

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years,
• Primary PTSD diagnosis
• Fluent in Swedish
• Access to the Internet at home or can use vouchers for internet-access to their phone.
• Parent/guardian willing and able to take part in treatment.

You may not qualify if:

• PTSD is not the primary concern
• Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
• Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention.
• Ongoing trauma-focused CBT or Eye movement desensitization and reprocessing Therapy
• Ongoing trauma-related threat

Sponsors & Collaborators

• Karolinska Institutet: lead
• Child and Adolescent Psychiatry, Stockholm: collaborator
• Save the Children: collaborator

Study Sites (1)

Barn och ungdomspsykiatrin, BUP Internetenhet and Save the Children

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Bragesjö, PhD

  Karolinska Institutet/Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Bragesjö

CONTACT

+46(0)703399387; maria.bragesjo@ki.se

Erica Mattelin

CONTACT

erica.mattelin@rb.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, clinical psychologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: March 11, 2024
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2028
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)