A Feasibility Mixed Methods Study of the Intervention Take Your Sexuality Back for Sexually Traumatized Women.

NCT07147855 | Not Yet Recruiting

• 1 other identifier: REK829297
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at the potential effects of a new group treatment called "Take Your Sexuality Back", designed for women who have experienced sexual trauma. Investigators will collect information in two ways-through forms that participants fill out themselves and through ECG measurements during a stress tests. Data will be collected before the treatment, right after it, and again three months later. When all data are collected and analyzed investigators will carry out in-depth interviews with participants and explore how they felt about being tested and how they understand the results -especially if some numbers look unusual or surprising. The goal with this study is to create a strong foundation for a future larger-scale study of the treatment by testing the methods, estimating the size of possible effects and identify outcome measurements that are experienced as meaningful to the participants.

Conditions

Posttraumatic Stress Symptoms; Sexual Abuse; Sexual Trauma

Outcome Measures

Primary Outcomes (8)

• PTSD-symptoms and complex PTSD symptoms

  The international trauma questionnaire (ITQ). Zero (0) is equivalent to nothing and 4 indicates extremely. Higher scores mean worse outcome.

  From enrollment to 3 month after end of treatment (12 weeks treatment)

• Sexual satisfaction

  The Sexual Satisfaction Scale for women (SSS-W). Different Likert scales. Higher scores mean worse outcome. Higher scores mean better outcome.

  From enrollment to 3 months after end of treatment (12 weeks intervention)

• Sexual shame

  The Sexual shame index-revised (SSI-R). One (1) is equivalent to strongly disagree and 6 indicates strongly agree. Higher scores mean worse outcome.

  From enrollment to 3 months after end of treatment (12 weeks intervention).

• Interoceptive awareness

  The Multidimensional Assessment of Interoceptive Awareness (MAYA 2). Zero is equivalent with never and 5 indicates always. Higher scores mean better outcome.

  From enrollment to 3 months after end of treatment (12 weeks intervention).

• Responses to script-driven imagery.

  The Responses to script-driven imagery (RSDI) measures emotional, cognitive, and physiological responses in the script-driven imagery procedure. Zero is equivalent to "not at all" and six (6) indicates "very much". Higher scores mean worse outcome.

  From enrollment to 3 months after end of treatment (12 weeks intervention).

• Touch body map

  Touch Body Map is an instrument for mapping how the body reacts to touch. Participants color the outlines of a human figure with three colors to mark how different areas of the body react to touch form a loved one. The body map gives a non-verbal expression of how trauma is embodied. The percentage of the different colors will be calculated to assess possible changes through the process

  From enrollment to 3 months after end of the treatment (12 weeks intervention).

• Change in HRV and SampEn from pre-post and at follow up efter 3 month.

  Cardiovascular measurement (ECG) recorded during a script-driven imagery (SDI). HRV and SampEn.

  Enrollment to 3 months after end of treatment (12 weeks intervention).

• Participants experiences of being tested and their understanding of the results.

  In-depth interviews with focus on participants own experiences and understanding og the quantitative results.

  Three month after end of treatment, when all quantitative results are analyzed and calculated.

Study Arms (1)

Treatment group "Take your sexuality back"

EXPERIMENTAL

A 12 week group intervention

Behavioral: Take your sexuality back

Interventions

Take your sexuality back BEHAVIORAL

A 12 weeks group program.

Treatment group "Take your sexuality back"

Eligibility Criteria

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

You may qualify if:

• A history of sexual trauma.
• Experience trauma-related sexual problems.
• Age between 18 and 65 years.
• Enough competence in Norwegian to participate in a psychoeducational group.

You may not qualify if:

• Acute suicidality.
• Serious substance abuse interfering with treatment
• Severe dissociative or psychotic disorders.
• Current life crisis interfering with treatment.
• Living in an abusive relationship. -

Sponsors & Collaborators

• Sykehuset Telemark: lead
• University of Agder: collaborator
• NTNU Health (sponsor): collaborator

Study Sites (1)

Sykehuset Telemark HF

Skien, Norway

Location

MeSH Terms

Conditions

Sexual Trauma

Condition Hierarchy (Ancestors)

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

Study Officials

• Hege Kersten, PhD

  Research and Innovation Manager

  STUDY DIRECTOR

Central Study Contacts

Idun Røseth, PhD

CONTACT

0047-41200462; IDUROE@sthf.no

Siv Åshild Billington

CONTACT

0047-97777857; Siv.Ashild.Billington@sthf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)