An interventional study of Condensed Internet delivered prolonged exposure (CIPE) in Post Traumatic Stress Disorder and Acute Stress Disorder, sponsored by Karolinska Institutet. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Condensed Internet delivered prolonged exposure (CIPE) for three weeks with therapist support.
Behavioral: Condensed Internet delivered prolonged exposure (CIPE)
Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
Participants satisfaction with treatment.
Qualitative questions pertaining participants satisfaction with the treatment.
Time frame: Immediately after treatment completion.
Adverse events related to treatment.
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.
Time frame: Immediately after treatment completion.
Number of completed treatment modules
Data will be gathered on total number of completed modules during the three week treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline up to three weeks
Number of drop-outs from treatment
Number of drop-outs from treatment
Time frame: 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.
Time frame: Baseline
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet