Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma

NCT06502106 | Not Yet Recruiting

• 1 other identifier: 2024-01105-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.

Conditions

Acute Stress Disorder; Post Traumatic Stress Disorder

Keywords

condensed prolonged exposure; PTSD; internetdelivered; 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.

  Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

Secondary Outcomes (7)

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

  Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

• Clinician Administered PTSD Scale version 5 (CAPS-5), the gold standard clinical interview to assess PTSD symptom severity and diagnosis of PTSD

  Three months after treatment completion.

• The International Trauma Questionnaire (ITQ)

  Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

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

  Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

• Change in quality of life measured by EQ-5D

  Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

Other Outcomes (12)

• Adverse events related to treatment measured by an openended question

  Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

• Adverse events realted to treatment measured by Negative effects questionnaire (NEQ)

  Post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.

• Participants satisfaction with treatment

  Immediately after treatment completion.

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:

• Experienced 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).
• At least mild clinical symptoms assessed using the PCL-5 cut-off \>10
• ≥ 18 years
• 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)
• 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
• Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus, Malmö: collaborator

Study Sites (1)

Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus

Malmo, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Stress Disorders, Post-Traumatic; 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: Princicpal investigator, PhD

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: July 9, 2024
• First Posted: July 16, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)