A Feasibility Mixed Methods Study of the Intervention Take Your Sexuality Back for Sexually Traumatized Women: Preliminary Evaluations of Efficacy and Outcome Measurements

Not Applicable

Not yet recruiting

• Conditions: Posttraumatic Stress Symptoms; Sexual Abuse; Sexual Trauma

• Registration Number: NCT07147855
• Lead Sponsor: Sykehuset Telemark

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. We will collect information in two ways-through forms that participants fill out themselves and through ECG measurements during a stress tests. We collect data before the treatment, right after it, and again three months later. When all data are collected and analyzed we 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

a) Acute suicidality, b) Serious substance abuse interfering with treatment, c) Severe dissociative or psychotic disorders, d) Current life crisis interfering with treatment e) Living in an abusive relationship.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PTSD-symptoms and complex PTSD symtpoms	From enrollment to 3 month after end of treatment (12 weeks treatment)	The international trauma questionnaire (ITQ). Zero (0) is equivalent to nothing and 4 indicates extremely.
Sexual satisfaction	From enrollment to 3 months after end of treatment (12 weeks intervention)	The Sexual Satisfaction Scale for women (SSS-W). Different Likert scales.
Sexual shame	From enrollment to 3 months after end of treatment (12 weeks intervention).	The Sexual shame index-revised (SSI-R). One (1) is equivalent to strongly disagree and 6 indicates strongly agree.
Interoceptive awareness	From enrollment to 3 months after end of treatment (12 weeks intervention).	The Multidimensional Assessment of Interoceptive Awareness (MAYA 2). Zero is equivalent with never and 5 indicates always.
Responses to script-driven imagery.	From enrollment to 3 months after end of treatment (12 weeks intervention).	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".
Touch body map	From enrollment to 3 months after end of the treatment (12 weeks intervention).	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
Change in HRV and SampEn from pre-post and at follow up efter 3 month.	Enrollment to 3 months after end of treatment (12 weeks intervention).	Cardiovascular measurement (ECG) recorded during a script-driven imagery (SDI). HRV and SampEn.
Participants experiences of being tested and their understanding of the results.	Three month after end of treatment, when all quantitative results are analyzed and calculated.	In-depth interviews with focus on participants own experiences and understanding og the quantitative results.

Trial Locations

Locations (1)

Sykehuset Telemark HF; 🇳🇴 Skien, Norway