Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD

Karolinska Institute

Status: Enrolling

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Therapist-supported internet-delivered prolonged exposure; Behavioral: Therapist-supported internet-delivered CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05934162

2023-02866-01

Details and patient eligibility

About

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.

Full 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?

Enrollment: 286 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

Therapist-supported internet delivered prolonged exposure

Experimental group

Description:

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.

Treatment:

Behavioral: Therapist-supported internet-delivered prolonged exposure

Therapist-supported CBT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Therapist-supported internet-delivered CBT