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NCT Number: NCT07147855

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

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.

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Key information

Conditions

Posttraumatic Stress Symptoms Mental Disorders Sexual Abuse Sexual Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset Telemark HF

Skien, Norway

Location contact

Idun Røseth, PhD

PRINCIPAL_INVESTIGATOR

Malin Wästlund, PhD-student

CONTACT

[email protected]

0047-95135546

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Take your sexuality back

Behavioral

A 12 weeks group program.

Primary outcomes

  1. PTSD-symptoms and complex PTSD symptoms

    Time frame: 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. Higher scores mean worse outcome.

  2. Sexual satisfaction

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

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

  3. Sexual shame

    Time frame: 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. Higher scores mean worse outcome.

  4. Interoceptive awareness

    Time frame: 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. Higher scores mean better outcome.

  5. Responses to script-driven imagery.

    Time frame: 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". Higher scores mean worse outcome.

  6. Touch body map

    Time frame: 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

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

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

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

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Idun Røseth, PhD

CONTACT

[email protected]

0047-41200462

Siv Åshild Billington

CONTACT

[email protected]

0047-97777857

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Norwegian University of Science and Technology
  • University of Agder

Registry information

Official study title

Take Your Sexuality Back - a Feasibility Study of a New Intervention for Sexually Traumatized Women: Preliminary Evaluations of Efficacy and Outcome Measurements

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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