About this trial
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
1. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other diagnosis or problem is assessed as primary to PTSD
Moderate to severe suicidal risk
PTSD from childhood trauma that the person cannot remember
Trial design
Parallel
Treatments tested in this trial
Blended Trauma focused Cognitive Behavioral Therapy (B-Tf-CBT)
BehavioralA trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.
Prolonged exposure
BehavioralA gold standard trauma-focused CBT delivered with face-to-face sessions with a therapist.
Treatment groups
Trial outcomes
Primary outcomes
The Posttraumatic stress disorder checklist 5 (PCL-5)
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)
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)
Self rated PTSD-symptoms. Minimum value 0, maximum value 80, where higher values indicate more PTSD symptoms.
Secondary outcomes
Clinician-administered PTSD Scale for DSM-5 (CAPS-5)
* The traumatic event. * The 20 PTSD symptoms according to DSM-5. * The onset of PTSD symptoms. * Duration of PTSD symptoms. * The degree of subjective discomfort and mental strain due to PTSD symptoms. * The degree of impairment in social, professional and other functioning due to PTSD symptoms. * The degree of symptom improvement since the previous CAPS assessment. * Reliability/validity of the client's responses (i.e. whether the responses are truthful). * Overall severity of the PTSD symptoms. * CAPS-5 contains estimates of dissociative subtypes (depersonalization and derealization) that are new to DSM-V (i.e., not included in DSM-IV criteria for PTSD). A 0-4 scale is used for each of the 30 items: (0 = absence of symptoms, 1 = mild/subthreshold, 2 = moderate/threshold, 3= severe/markedly elevated, 4 = extreme/disabling)
Clinician-administered PTSD Scale for DSM-5 (CAPS-5)
* The traumatic event. * The 20 PTSD symptoms according to DSM-5. * The onset of PTSD symptoms. * Duration of PTSD symptoms. * The degree of subjective discomfort and mental strain due to PTSD symptoms. * The degree of impairment in social, professional and other functioning due to PTSD symptoms. * The degree of symptom improvement since the previous CAPS assessment. * Reliability/validity of the client's responses (i.e. whether the responses are truthful). * Overall severity of the PTSD symptoms. * CAPS-5 contains estimates of dissociative subtypes (depersonalization and derealization) that are new to DSM-V (i.e., not included in DSM-IV criteria for PTSD). A 0-4 scale is used for each of the 30 items: (0 = absence of symptoms, 1 = mild/subthreshold, 2 = moderate/threshold, 3= severe/markedly elevated, 4 = extreme/disabling)
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale. The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV. You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale. The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV. You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Capio Group
Collaborator
Stockholm University
Collaborator
Region Stockholm
Collaborator