Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD
NCT ID: NCT05934162
Last Updated: 2023-12-07
Study Results
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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RECRUITING
NA
286 participants
INTERVENTIONAL
2023-09-04
2026-08-20
Brief Summary
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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
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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?
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Therapist-supported internet delivered prolonged exposure
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.
Therapist-supported internet-delivered prolonged exposure
10 weeks of therapist-supported internet-delivered prolonged exposure
Therapist-supported CBT
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.
Therapist-supported internet-delivered CBT
10 weeks of therapist-supported internet-delivered CBT
Interventions
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Therapist-supported internet-delivered prolonged exposure
10 weeks of therapist-supported internet-delivered prolonged exposure
Therapist-supported internet-delivered CBT
10 weeks of therapist-supported internet-delivered CBT
Eligibility Criteria
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Inclusion 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
* 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)
18 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Maria Bragesjo
Clinical psychologist, PhD
Principal Investigators
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Maria Bragesjö, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Traumaprogrammet, Psykiatri Sydväst
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Maria Bragesjö, PhD
Role: primary
Other Identifiers
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2023-02866-01
Identifier Type: -
Identifier Source: org_study_id