NCT07165834

Brief Summary

This study aims to gain insight into the experiences of participants in the "Take Your Sexuality Back" intervention groups, evaluate the intervention's acceptability, and identify necessary modifications. This study is part of a larger project that seeks to establish a scientific basis for this innovative, group-based treatment to help women who have experienced sexual trauma heal their sexuality. Before implementing the intervention in the healthcare system and initiating a larger randomized controlled trial, the investigators will evaluate the intervention's feasibility and potential efficacy, as well as gain a more comprehensive understanding of treatment outcomes. In addition to collecting quantitative data, it is crucial to gather qualitative data on participants' experiences. In this study, data will be obtained through in-depth interviews with group participants after they complete the intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Sep 2025Dec 2028

First Submitted

Initial submission to the registry

August 21, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

August 21, 2025

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • What are the participants lived experiences of participating in the group intervention "Take your sexuality back"

    In-depth interviews investigating participants experiences and perceptions of the intervention, and how they react to any positive or negative impacts attributed to it. Interviews will be analyzed through a descriptive phenomenological method.

    1-2 weeks after end of treatment

Study Arms (1)

Treatment group. "Take your sexuality back"

EXPERIMENTAL

"Take your sexuality back" is a 12 week group intervention for sexually traumatized women.

Behavioral: Treatment group. "Take your sexuality back"

Interventions

The intervention is trauma-sensitive and focus both on traumatized sexuality and positive sexuality. It incorporates regulatory skills to prevent re-traumatization when addressing sex-positive themes, thus accommodating a wide range of trauma-related symptoms, sexual shame, sexual dysfunctions, and regulation difficulties. The intervention integrates psychoeducation, exercises, reflections and sharing.

Treatment group. "Take your sexuality back"

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Telemark HF

Skien, Norway

RECRUITING

MeSH Terms

Conditions

Sexual Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Hege Kersten, PhD

    Research and Innovation Manager

    STUDY DIRECTOR

Central Study Contacts

Idun Røseth, PhD

CONTACT

Siv Åshild Billington

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research

Study Record Dates

First Submitted

August 21, 2025

First Posted

September 10, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Qualitative data are sensitive and participant anonymity cannot be guaranteed.

Locations