NCT06318195

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

Internet Delivered Condensed Cognitive Behavioral Treatment (Prolonged Exposure) for Individuals Treated Within Somatic Trauma Care.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Post Traumatic Stress Disorder
• Acute Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Condensed Internet delivered prolonged exposure (CIPE)	Condensed Internet delivered prolonged exposure (CIPE) with therapist support for three weeks.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2024-03-19
• Last updated: 2024-07-10

Locations

1 site across 1 country: Sweden