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

Karolinska Institute

Status

Not yet enrolling

Conditions

Acute Stress Disorder

Post Traumatic Stress Disorder

Treatments

Behavioral: Condensed Internet delivered prolonged exposure (CIPE)

Study type

Interventional

Funder types

Other

Identifiers

NCT06318195

2023-06821-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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