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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.
The study is un-controlled with 250 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is the PCL-5. Secondary outcomes are level of depression (PHQ-9), quality of life (WSAS) and predictors, moderators and mediators of clinically meaningful change in symptoms, dropout rate, rates of inclusion, attrition, adherence,and negative effects.
Self-reported, qualitative data from participants will be gathered at treatment completion to capture participants' experiences of participating in the intervention, as well as their views on how to further improve the intervention. The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm, Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condensed Internet delivered prolonged exposure (CIPE) | Experimental | Condensed Internet delivered prolonged exposure (CIPE) for three weeks with therapist support. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Condensed Internet delivered prolonged exposure (CIPE) | Behavioral | Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) | The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms. | week -3, -2 and -1 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. Scores are calculated based on how frequently a person experiences 9 symptoms of depression ranging from "not at all" response is scored as 0; "several days" response is 1; "more than half the days" response is 2; and "nearly every day" response is 3. Higher scores represents more depressive symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants satisfaction with treatment. | Qualitative questions pertaining participants satisfaction with the treatment. | Immediately after treatment completion. |
| Adverse events related to treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Bragesjö, PhD | Contact | +46703399387 | maria.bragesjo@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Maria Bragesjö, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D040701 | Stress Disorders, Traumatic, Acute |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Prolonged exposure will be offered in a brief digital format with therapist support for three weeks. Treatment comprises of psychoeducation, rationales, in vivo exposure, imaginal exposure and relapse prevention.
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| week -3 before treatment start, immediately before start of treatment, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up. |
| Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress. | WSAS is a short, self-reported instrument consisting of five items about psychosocial impairments rated on a nine-point Likert scale. A higher score means more severe impairment. | week -3 before treatment start, immediately before start of treatment, , weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month and 6 months follow up. |
Adverse events related to treatment measured by with a free text option where participant is instructed to describe the possible event in detail. If the participant reported any adverse event, additional follow-up questions about intensity, duration etc. will also be given.
| Immediately after treatment completion. |
| Number of completed treatment modules | Data will be gathered on total number of completed modules during the three week treatment. | Baseline up to 3 weeks |
| Number of messages sent and received in the digital platform | Data will be gathered on total number of messages sent and received in the digital platform during the three week treatment. | Baseline up to 3 weeks |
| Number of completed home work assignments by the participant during the treatment period | Data will be gathered on total number of completed home work assignments by the participant during the three week treatment. | Baseline up to 3 weeks |
| The proportion of participants that conducts the weekly measures and further assessment points | The proportion of participants that conducts the weekly measures and further assessment points | Baseline up to 6 months |
| The proportion of participants that go through the entire treatment period | The proportion of participants that go through the entire treatment period | Baseline up to three weeks |
| Number of drop-outs from treatment | Number of drop-outs from treatment | Baseline up to three weeks |
| Rates of inclusion to the study | Data on rates of inclusion will be considered as an indication of the feasibility of the intervention. | Baseline |