A Feasibility Mixed Methods Study of the Intervention Take Your Sexuality Back for Sexually Traumatized Women.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Take your sexuality back.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Symptoms, Sexual Abuse, Sexual Trauma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Take Your Sexuality Back - a Feasibility Study of a New Intervention for Sexually Traumatized Women: Preliminary Evaluations of Efficacy and Outcome Measurements
Overview
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.
Interventions
- Behavioral Take your sexuality back
A 12 weeks group program.
Primary outcome measures
- PTSD-symptoms and complex PTSD symptoms [Time frame: From enrollment to 3 month after end of treatment (12 weeks treatment)]
- Sexual satisfaction [Time frame: From enrollment to 3 months after end of treatment (12 weeks intervention)]
- Sexual shame [Time frame: From enrollment to 3 months after end of treatment (12 weeks intervention).]
- Interoceptive awareness [Time frame: From enrollment to 3 months after end of treatment (12 weeks intervention).]
- Responses to script-driven imagery. [Time frame: From enrollment to 3 months after end of treatment (12 weeks intervention).]
- Touch body map [Time frame: 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. [Time frame: Enrollment to 3 months after end of treatment (12 weeks intervention).]
- 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.]
Eligibility criteria
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. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Sykehuset Telemark HF — Skien
Identifiers
NCT: NCT07147855 · REK829297