Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin
Stockholm, Sweden
Location contact
Charlotte Gentili, PhD
CONTACT
Mike Kemani, PhD
CONTACT
NCT Number: NCT06318195
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
Charlotte Gentili, PhD
CONTACT
Mike Kemani, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.
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.
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 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.
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.
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: Immediately after treatment completion.
Qualitative questions pertaining participants satisfaction with the treatment.
Time frame: Immediately after treatment completion.
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: Baseline up to 3 weeks
Data will be gathered on total number of completed modules during the three week treatment.
Time frame: Baseline up to 3 weeks
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
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 6 months
The proportion of participants that conducts the weekly measures and further assessment points
Time frame: Baseline up to three weeks
The proportion of participants that go through the entire treatment period
Time frame: Baseline up to three weeks
Number of drop-outs from treatment
Time frame: Baseline
Data on rates of inclusion will be considered as an indication of the feasibility of the intervention.
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Internet Delivered Condensed Cognitive Behavioral Treatment (Prolonged Exposure) for Individuals Treated Within Somatic Trauma Care.
Acronym: CiPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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