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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- The Posttraumatic stress disorder checklist 5 (PCL-5)
Study Overview
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
Primary
- Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 post-treatment?
Secondary: 2. Is bTF-CT non-inferior to prolonged exposure (PE) when delivered in routine clinical care in terms of PTSD symptoms on the PCL-5 at 6 and 12 months follow up? 3. Are there significant differences between bTF-CT and PE when delivered in routine clinical care in terms of depression, anxiety, insomnia, functionality, complex PTSD, other PTSD-measures and treatment satisfaction post-treatment and at 6 and 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.
In accordance with CONSORT recommendations for non-inferiority trials, both intention-to-treat (ITT) and per-protocol (PP) analyses will be performed and reported for the primary non-inferiority comparisons. Secondary outcomes will be analyzed using ITT principles.
ITT population All randomized participants who completed the pre-treatment assessment and participated in the inclusion session.
PP population The PP population will include participants who have received at least 50% of the planned total treatment dose, defined across both digital modules and face-to-face sessions in the blended format.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessor of secondary outcome CAPS will be masked to participant allocation at post and follow-up assessments.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)
B-Tf-CBT shares key features with Internet-based CBT (I-CBT) in that it is based on a digital support accessible to the patient. This digital support equips blended treatment with the same proposed advantages as I-CBT in terms of improving treatment accessibility, adherence, and reducing therapist-time. In addition, incorporating 6 biweekly face-to-face sessions to facilitate and augment delivery of more demanding components of TF-CBT such as memory exposure.
Intervention: Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT) (Behavioral)
Prolonged exposure
Gold standard Tf-CBT Prolonged exposure will constitute the control condition. Prolonged exposure will be delivered by trained therapists under supervision adhering to the evidence based manual delivered face-to-face over 9-15 weeks.
Intervention: Prolonged exposure (Behavioral)
Outcomes
Primary Outcomes
The Posttraumatic stress disorder checklist 5 (PCL-5)
Time Frame: Change from pre intervention to 12 months post intervention
Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
The Posttraumatic stress disorder checklist 5 (PCL-5)
Time Frame: Change from pre intervention to immediately post intervention
Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
The Posttraumatic stress disorder checklist 5 (PCL-5)
Time Frame: Change from pre intervention to 6 months post intervention
Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
Secondary Outcomes
- EUROQOL 5 dimensions (EQ5D)(Change from pre intervention to 12 months post intervention)
- Questions about work situation(12 months post intervention)
- Registry data for the cost-effectiveness analysis(During the 12 month period post intervention)
- Posttraumatic cognitions inventory (PTCI)(12 months post intervention)
- The Response to Intrusions Questionnaire (RIQ)(12 months post intervention)
- The internet intervention Patient Adherence Scale (iiPAS)(Immediately post intervention)
- Client Satisfaction Questionnaire (CSQ-8)(Immediately post intervention)
- Negative Effects Questionnaire (NEQ)(Immediately post intervention)
- Clinician-administered PTSD Scale for DSM-5 (CAPS-5)(12 months post intervention)
- Patient Health Questionnaire (PHQ-9)(Change from pre intervention to 12 months post intervention)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(Change from pre intervention to 12 months post intervention)
- Insomnia Severity Index (ISI)(Change from pre intervention to 12 months post intervention)
- The Work and Social Adjustment Scale (WSAS)(Change from pre intervention to 12 months post intervention)
- credibility/expectancy questionnaire(Two weeks post intervention start)
- Clinician-administered PTSD Scale for DSM-5 (CAPS-5)(12 months post intervention)
- Questions about work situation(12 months post intervention)
- Patient Health Questionnaire (PHQ-9)(Change from pre intervention to 12 months post intervention)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(Change from pre intervention to 12 months post intervention)
- Insomnia Severity Index (ISI)(Change from pre intervention to 12 months post intervention)
- The Work and Social Adjustment Scale (WSAS)(Change from pre intervention to 12 months post intervention)
- EUROQOL 5 dimensions (EQ5D)(Change from pre intervention to 12 months post intervention)
- Registry data for the cost-effectiveness analysis(During the 12 month period post intervention)
- Posttraumatic cognitions inventory (PTCI)(12 months post intervention)
- The Response to Intrusions Questionnaire (RIQ)(12 months post intervention)
- The internet intervention Patient Adherence Scale (iiPAS)(Immediately post intervention)
- International Trauma Questionnaire(12 months post intervention for participants included 2025)
- Client Satisfaction Questionnaire (CSQ-8)(Immediately post intervention)
- Negative Effects Questionnaire (NEQ)(Immediately post intervention)
- credibility/expectancy questionnaire(Two weeks post intervention start)
- Autonomy, Flexibility, and Alliance Scale (study-specific measure)(6 months post intervention for participants included 2025)
- Clinician-administered PTSD Scale for DSM-5 (CAPS-5)(1 week post intervention)
- Patient Health Questionnaire (PHQ-9)(Change from pre intervention to immediately post intervention)
- The Work and Social Adjustment Scale (WSAS)(Change from pre intervention to immediately post intervention)
- Patient Health Questionnaire (PHQ-9)(Change from pre intervention to 6 months post intervention)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(Change from pre intervention to immediately post intervention)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(Change from pre intervention to 6 months post intervention)
- Insomnia Severity Index (ISI)(Change from pre intervention to immediately post intervention)
- Insomnia Severity Index (ISI)(Change from pre intervention to 6 months post intervention)
- The Work and Social Adjustment Scale (WSAS)(Change from pre intervention to 6 months post intervention)
- EUROQOL 5 dimensions (EQ5D)(Change from pre intervention to immediately post intervention)
- EUROQOL 5 dimensions (EQ5D)(Change from pre intervention to 6 months post intervention)
- Questions about work situation(Pre intervention)
- Questions about work situation(6 months post intervention)
- Posttraumatic cognitions inventory (PTCI)(Pre intervention)
- Posttraumatic cognitions inventory (PTCI)(6 weeks post intervention start)
- Posttraumatic cognitions inventory (PTCI)(immediately post intervention)
- Posttraumatic cognitions inventory (PTCI)(6 months post intervention)
- The Response to Intrusions Questionnaire (RIQ)(Pre intervention)
- The Response to Intrusions Questionnaire (RIQ)(6 weeks post intervention start)
- The Response to Intrusions Questionnaire (RIQ)(Immediately post intervention)
- The Response to Intrusions Questionnaire (RIQ)(6 months post intervention)
- The internet intervention Patient Adherence Scale (iiPAS)(6 weeks post intervention start)
- International Trauma Questionnaire(Pre intervention for participants included 2025)
- International Trauma Questionnaire(Immediately post intervention for participants included 2025)
- International Trauma Questionnaire(6 months post intervention for participants included 2025)
- Autonomy, Flexibility, and Alliance Scale (study-specific measure)(Immediately post intervention for participants included 2025)
Investigators
Sigrid Salomonsson
Principal investigator, PhD
Karolinska Institutet