Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Exposed to trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
PCL-5 total sum score>10
≥ 18 years
Situated in Sweden
Disqualifiers
Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
Unable to read and write in Swedish
Receiving other psychological trauma-focused treatment
Ongoing trauma-related threat (e.g., living with a violent spouse)
Trial design
Design model
Single group
Treatments tested in this trial
Condensed Internet delivered prolonged exposure (CIPE)
BehavioralCondensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Condensed Internet delivered prolonged exposure (CIPE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.Other outcomes
1
Participants satisfaction with treatment.
Qualitative questions pertaining participants satisfaction with the treatment.
Time frame
Immediately after treatment completion.2
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.3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov
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