Clinical trial NCT05934162: Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD
Official title: Efficacy and Mediators of Change of Cognitive-behavior Therapy for PTSD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
therapist-guided treatment
internet delivered treatment
digital treatment
therapist-assisted treatment
prolonged exposure
trauma focused CBT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-07-06
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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?

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)

Primary outcomes:
measure: Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment
Secondary outcomes:
measure: Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
timeFrame: Baseline, through the treatment period up to 10 weeks and 1-month, 6-month and 12-month post-treatment]
measure: Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Change in quality of life measured by Euroqol, EQ-5D
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Change in Assessing Quality of Life 6 Dimensions (AQoL-6D)
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
timeFrame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Adverse events related to treatment measured by the Negative effects questionnaire
timeFrame: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
measure: Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
timeFrame: Immediately after treatment completion
measure: Number of completed treatment modules
timeFrame: Baseline up to treatment completion at 10 weeks
measure: Number of messages sent and received in the digital platform
timeFrame: Baseline up to treatment completion at 10 weeks
Other outcomes:
measure: Differences in treatment credibility between arms
timeFrame: After completion of the first treatment module (week 1 from baseline)
measure: Differences in experience of working alliance between arms
timeFrame: After completion of the third module (week 3 from baseline)
Locations:
city: Stockholm
country: Sweden
facility: Traumaprogrammet, Psykiatri Sydväst
Study officials:
affiliation: Karolinska Institutet
name: Maria Bragesjö, PhD
role: PRINCIPAL_INVESTIGATOR
References: