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

NCT ID: NCT06502106

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-10-31

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.

Detailed Description

The study is un-controlled with 30 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 level of symptoms of post traumatic stress rated by the PCL-5. Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 (CAPS-5) and The International Trauma Questionnaire (ITQ), level of depression (PHQ-9), quality of life (WSAS and EQ-5D ) dropout rate, rates of inclusion, attrition, adherence,and negative effects.

Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it.

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 for sexual assault at Traumamottagning Centrum för Sexuell Hälsa, Malmö.

Conditions

Acute Stress Disorder; Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Condensed Internet delivered prolonged exposure (CIPE)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus, Malmö

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Maria Bragesjo

Princicpal investigator, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Bragesjö, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Traumamottagning Centrum för Sexuell Hälsa, Skånes Universitetssjukhus

Malmo, , Sweden

Countries

Sweden

Central Contacts

Maria Bragesjö, PhD

Role: CONTACT

maria.bragesjo@ki.se

+46703399387

Facility Contacts

Erik Wallmark, MSc

Role: primary

erik.wallmark@skane.se

+46(0)40-33 34 46

Other Identifiers

2024-01105-01

Identifier Type: -

Identifier Source: org_study_id