Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapist-supported internet-delivered prolonged exposure, Therapist-supported internet-delivered CBT.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Mediators of Change of Cognitive-behavior Therapy for PTSD: a Randomized Controlled Trial
Overview
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.
Detailed description
PTSD is a debilitating psychiatric disorder strongly linked to subsequent psychiatric and medical problems. Trauma-focused cognitive behavioral therapy (CBT-T) such as prolonged exposure is an effective treatment for PTSD and is recommended in most clinical guidelines as first-line treatment but is seldom available in regular care. A possible solution to significantly improve access to evidence-based treatment would be the use of remotely delivered digital intervention. Preliminary research shows that therapist-guided internet delivered to be effective and safe, but studies have typically excluded patients with severe PTSD.
Before this type of treatment can be offered in regular care in Sweden, it needs to be further evaluated also with psychiatric patients suffering from severe PTSD. If therapist-guided internet delivered prolonged exposure would be found to effective, this project has the potential to be the first step towards implementation of a novel, superior and more cost-effective mode of treatment delivery for adults with PTSD in regular Swedish health care.
The study is a single-blind, parallel-group superiority randomized controlled trial with 284 patients (142 per arm) that will compare therapist-guided internet delivered prolonged exposure with therapist-guided internet delivered cognitive-behavioral therapy The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Secondary outcomes are cost effectiveness, mediators of change, dropout rate, and negative effects.
The trial will also be preregistered at the Open Science Framework.
Research questions to be answered are:
1. Is guided i-CBT with exposure more efficacious than an active control condition (therapist-supported internet-delivered psychoeducation, relaxation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment? 2. Is guided i-CBT with exposure more cost-effective than an active control condition (therapist-supported internet-delivered psychoeducation, relaxation and support) in regard to reduction of blinded assessor rated PTSD symptom severity 1-month post-treatment? 3. Are the therapeutic gains of i-CBT maintained at long term follow up (6 and 12 months after treatment)? 4. Is guided i-CBT with exposure more efficacious than an active control condition (therapist-supported internet-delivered psychoeducation, relaxation and support) in regard to reduction in depressive symptoms and increase in quality of life up to 12 months after treatment completion? 5. What are the mediators of change in guided i-CBT for PTSD?
Interventions
- Behavioral Therapist-supported internet-delivered prolonged exposure
10 weeks of therapist-supported internet-delivered prolonged exposure - Behavioral Therapist-supported internet-delivered CBT
10 weeks of therapist-supported internet-delivered CBT
Primary outcome measures
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) [Time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment]
Secondary outcome measures (10)
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) [Time frame: 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). [Time frame: 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) [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Change in quality of life measured by Euroqol, EQ-5D [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Change in Assessing Quality of Life 6 Dimensions (AQoL-6D) [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P) [Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Adverse events related to treatment measured by the Negative effects questionnaire [Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment]
- Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8). [Time frame: Immediately after treatment completion]
- Number of completed treatment modules [Time frame: Baseline up to treatment completion at 10 weeks]
- Number of messages sent and received in the digital platform [Time frame: Baseline up to treatment completion at 10 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Traumaprogrammet, Psykiatri Sydväst — Stockholm
Publications
- 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;27(1):43. doi: 10.1186/s13063-025-09361-0. PMID 41388429
Identifiers
NCT: NCT05934162 · 2023-02866-01