Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD

NCT05934162 | Recruiting

• 1 other identifier: 2023-02866-01
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare therapist-guided internet delivered prolonged exposure to an active control condition( therapist-guided internet delivered cognitive behavioral therapy containing relaxation techniques) for post-traumatic stress disorder. The objective with this study is to investigate efficacy, mechanisms of change and cost effectiveness of therapist-guided internet delivered prolonged exposure. Adult patients with post-traumatic stress disorder will be randomly assigned to receive either 10 weeks of therapist-guided internet delivered prolonged exposure or therapist-guided internet delivered cognitive-behavioral therapy containing relaxation.

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; therapist-guided treatment; internet delivered treatment; digital treatment; therapist-assisted treatment; prolonged exposure; trauma focused CBT

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)

  The CAPS-5 is 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 post-treatment

Secondary Outcomes (10)

• Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)

  Baseline, through the treatment period up to 10 weeks and 1-month, 6-month and 12-month post-treatment]

• Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).

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

• Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

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

• Change in quality of life measured by Euroqol, EQ-5D

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

• Change in Assessing Quality of Life 6 Dimensions (AQoL-6D)

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

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 prolonged exposure

EXPERIMENTAL

Therapist-supported internet delivered prolonged exposure comprising psychoeducation about PTSD, controlled breathing, imaginal exposure including processing, in vivo exposure and relapse prevention. The treatment will be delivered in a digital platform for ten weeks. Participants will have access to a therapist that will guide them through treatment in a text based format.

Behavioral: Therapist-supported internet-delivered prolonged exposure

Therapist-supported CBT

ACTIVE COMPARATOR

Therapist-supported CBT internet-delivered treatment comprising psychoeducation about PTSD, relaxation techniques and relapse prevention. . The treatment will be delivered in a digital platform for ten weeks. Participants will have access to a therapist that will guide them through treatment in a text based format.

Behavioral: Therapist-supported internet-delivered CBT

Interventions

Therapist-supported internet-delivered prolonged exposure BEHAVIORAL

10 weeks of therapist-supported internet-delivered prolonged exposure

Therapist-supported internet delivered prolonged exposure

Therapist-supported internet-delivered CBT BEHAVIORAL

10 weeks of therapist-supported internet-delivered CBT

Therapist-supported CBT

Eligibility Criteria

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

You may qualify if:

• current primary diagnosis PTSD according to DSM-5 diagnostic criteria
• be 18 years of age or older
• be able to read and communicate fluently in Swedish
• have had a stable dose of any psychotropic medication for at least 4 weeks prior to study entry
• Daily access to a computer or device with internet connection

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 (e.g. living with a violent spouse)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Traumaprogrammet, Psykiatri Sydväst

Stockholm, Sweden

RECRUITING

Related Publications (1)

• Bragesjo M, Ivanov VZ, Andersson E, Ruck C. Study protocol of a randomized controlled superiority trial of Huddinge Online Prolonged Exposure therapy (HOPE) for adults with posttraumatic stress disorder. Trials. 2025 Dec 12. doi: 10.1186/s13063-025-09361-0. Online ahead of print.

  PMID: 41388429 DERIVED

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Bragesjö, PhD

CONTACT

0703399387; maria.bragesjo@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded assessors are used Participants know that are given a CBT treatment for PTSD
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical psychologist, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 6, 2023
• Study Start: September 4, 2023
• Primary Completion: August 20, 2025
• Study Completion (Estimated): August 20, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)