Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Traumatic Stress Disorder Acute Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Condensed Internet delivered prolonged exposure (CIPE)

Condensed Internet delivered prolonged exposure (CIPE) for three weeks with therapist support.

Group Type EXPERIMENTAL

Condensed Internet delivered prolonged exposure (CIPE)

Intervention Type BEHAVIORAL

Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.

Interventions

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Condensed Internet delivered prolonged exposure (CIPE)

Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* Signed informed consent

Exclusion Criteria

* 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)
* Not stable dose of antidepressant medication the last two weeks

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No