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

NCT06318195 | Not Yet Recruiting

• 1 other identifier: 2023-06821-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Traumatic Stress Disorder; Acute Stress Disorder

Keywords

condensed prolonged exposure; Internet-delivered; PTSD; trauma; early intervention; prevention; CIPE

Outcome Measures

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.

  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 (2)

• Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

  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.

• Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.

  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 (9)

• Participants satisfaction with treatment.

  Immediately after treatment completion.

• Adverse events related to treatment.

  Immediately after treatment completion.

• Number of completed treatment modules

  Baseline up to 3 weeks

Study Arms (1)

Condensed Internet delivered prolonged exposure (CIPE)

EXPERIMENTAL

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

Behavioral: Condensed Internet delivered prolonged exposure (CIPE)

Interventions

Condensed Internet delivered prolonged exposure (CIPE) BEHAVIORAL

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

Condensed Internet delivered prolonged exposure (CIPE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin

Stockholm, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Maria Bragesjö, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Bragesjö, PhD

CONTACT

+46703399387; maria.bragesjo@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Licensed Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)