Clinical trial NCT05758987: Blended Treatment för PTSD: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy
Official title: Evaluation of Blended CBT for PTSD in Regular Care: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy: A Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
CBT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Capio Group
name: Stockholm University
name: Region Stockholm
First posted: 2023-03-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled non-inferiority trial evaluating if the new blended Tf-CBT is non inferior to the gold standard PTSD treatment Prolonged exposure. The trial is a multicenter study conducted at 3-6 sites. Participants are individually randomized in blocks of 2-4 at each site.
Primary purpose: TREATMENT

Brief summary: A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE).

Research question and hypothesis Can the blended treatment yield outcomes non-inferior to face-to-face TF-CBT for patients with PTSD when applied in regular health care with regards to PTSD-symptoms, depression, anxiety, sleep problems, quality of life and general functioning? The hypothesis is that the Blended TF-CBT will be non-inferior to standard face-to-face TF-CBT for patients with PTSD, directly after treatment as well as at 12-months follow up. The study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.

Detailed description: To study effects, the investigators aim to conduct a randomized controlled trial (RCT) comparing blended treatment to an evidence-based face-to-face TF-CBT protocol, Prolonged exposure.

Data will be collected concerning symptoms of PTSD with the PTSD Checklist for Diagnostic and Statistical Manual 5 (DSM-5; PCL-5) which will be the primary outcome measure. Further, symptoms of PTSD will be measured with Clinician-administered PTSD Scale for DSM-5 (CAPS-5), depression The PHQ-9, symptoms of anxiety with GAD-7 , quality of life with Work and social adjustment scale (WSAS), and sleep with the insomnia severity index (ISI). Outcome measures will be distributed before, during, after, as well as 12-months following treatment.

To analyze the data, a non-inferiority analysis will be applied for the primary outcome variable. Step one in this analysis will be to determine what difference in mean scores on the PCL-5 between the two treatments is tolerated to conclude that the interventions are equally effective (non-inferiority margin). When comparing treatment effects a one-sided t-test with a 95% confidence interval will be used to investigate whether the lower limit of the interval for the experimental treatment (blended treatment) lays outside the non-inferiority margin. If the lower limit is within the non-inferiority margin the experimental treatment is interpreted to be non-inferior to the standard treatment (TF-CBT).

The value of our non-inferiority margin will be based on the established minimum change in scores required for a reliable change on the primary outcome measure as well as the effect size (Cohen's d) seen in a previous TF-CBT study (29). As a first step to determine our non-inferiority margin the investigators made a calculation entailing the following estimates: The post treatment score on the primary measure from the reference treatment which was 15.80 with a standard deviation of 15.97 (we assumed that our treatment would yield the same post-score). 7 which is the score in between the established minimal difference on the primary outcome measure required for a reliable change (reliable change = between 5 and 10 points). 7 points on the primary outcome measure is thus the non-inferiority margin in actual scores. Appointing these figures in an effect size calculator yielded the result of 0.4. This indicates that while expecting a zero difference in effect size between the two treatments in comparison, the tolerated non-inferiority margin in Cohen's d is 0.4.

Further, to estimate the required sample size, rigorous power calculations were carried out in collaboration with an expert in statistical analysis, applying a simulation-based approach using a 2-level linear mixed-effects model, using estimates from the reference TF-CBT looking at six assessment points. Variance components that were incorporated into the analysis were random intercept, random slopes and residual variance. The power calculation showed that with 78 participants in each treatment group and a 20% dropout rate 80% power is reached, given a non-inferiority margin of 7 points and α = 0.05.

Continuous data will be analyzed using mixed effects models or t-tests, dichotomous data using chi-square tests. In mixed effects model analysis of between-group differences, the interaction effect of group and time will be the central estimate. The investigators will also calculate effect sizes using Cohen's d based on pooled standard deviations. Remission rates will be calculated using a cut off of 38 on the PCL-5. The proportion of patients who will make a clinical significant change and reliable change according to the Jacobson and Truax algorithm will be measured. Dichotomous data of remission will also be analyzed with survival analysis where time to remission is calculated and compared between groups.

Eligibility criteria: Inclusion Criteria:

* PTSD according to Diagnostic and Statistical Manual of mental disorders 5 as primary problem
* ≥ 18 years
* Basic knowledge of speaking and writing Swedish
* No other psychological treatment at the same time
* No ongoing threats or violence
* If antidepressant medication, stable dose 6 weeks before starting treatment
* Have access to the internet and a computer
* Willingness/ability to participate after receiving information about what participation entails

Exclusion Criteria:

* Other diagnosis or problem is assessed as primary to PTSD
* Moderate to severe suicidal risk
* PTSD from childhood trauma that the person cannot remember

Primary outcomes:
measure: The Posttraumatic stress disorder checklist 5 (PCL-5)
timeFrame: Change from pre intervention to immediately post intervention
measure: The Posttraumatic stress disorder checklist 5 (PCL-5)
timeFrame: Change from pre intervention to 6 months post intervention
measure: The Posttraumatic stress disorder checklist 5 (PCL-5)
timeFrame: Change from pre intervention to 12 months post intervention
Secondary outcomes:
measure: Clinician-administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: 1 week post intervention
measure: Clinician-administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: 12 months post intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to immediately post intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to 6 months post intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from pre intervention to 12 months post intervention
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to immediately post intervention
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to 6 months post intervention
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from pre intervention to 12 months post intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to immediately post intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to 6 months post intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Change from pre intervention to 12 months post intervention
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to immediately post intervention
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to 6 months post intervention
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from pre intervention to 12 months post intervention
measure: EUROQOL 5 dimensions (EQ5D)
timeFrame: Change from pre intervention to immediately post intervention
measure: EUROQOL 5 dimensions (EQ5D)
timeFrame: Change from pre intervention to 6 months post intervention
measure: EUROQOL 5 dimensions (EQ5D)
timeFrame: Change from pre intervention to 12 months post intervention
measure: Questions about work situation
timeFrame: Pre intervention
measure: Questions about work situation
timeFrame: 6 months post intervention
measure: Questions about work situation
timeFrame: 12 months post intervention
measure: Registry data for the cost-effectiveness analysis
timeFrame: During the 12 month period post intervention
measure: Posttraumatic cognitions inventory (PTCI)
timeFrame: Pre intervention
measure: Posttraumatic cognitions inventory (PTCI)
timeFrame: 6 weeks post intervention start
measure: Posttraumatic cognitions inventory (PTCI)
timeFrame: immediately post intervention
measure: Posttraumatic cognitions inventory (PTCI)
timeFrame: 6 months post intervention
measure: Posttraumatic cognitions inventory (PTCI)
timeFrame: 12 months post intervention
measure: The Response to Intrusions Questionnaire (RIQ)
timeFrame: Pre intervention
measure: The Response to Intrusions Questionnaire (RIQ)
timeFrame: 6 weeks post intervention start
measure: The Response to Intrusions Questionnaire (RIQ)
timeFrame: Immediately post intervention
measure: The Response to Intrusions Questionnaire (RIQ)
timeFrame: 6 months post intervention
measure: The Response to Intrusions Questionnaire (RIQ)
timeFrame: 12 months post intervention
measure: The internet intervention Patient Adherence Scale (iiPAS)
timeFrame: 6 weeks post intervention start
measure: The internet intervention Patient Adherence Scale (iiPAS)
timeFrame: Immediately post intervention
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Immediately post intervention
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Immediately post intervention
measure: credibility/expectancy questionnaire
timeFrame: Two weeks post intervention start
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: