Posttraumatic Stress SymptomsNCT07147855
A Feasibility Mixed Methods Study of the Intervention Take Your Sexuality Back for Sexually Traumatized Women.
A study testing Take your sexuality back in people with Posttraumatic Stress Symptoms and Sexual Abuse, run by Sykehuset Telemark at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Symptoms, Sexual Abuse, Sexual Trauma
- What is being tested?
- Take your sexuality back
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute suicidality.
- Serious substance abuse interfering with treatment
- Severe dissociative or psychotic disorders.
- Current life crisis interfering with treatment.
- Living in an abusive relationship. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Sykehuset Telemark HF
Skien
Malin Wästlund, PhD-student, 0047-95135546, malin.wastlund@nenett.no
Idun Røseth, PhD
About this study
Official title: Take Your Sexuality Back - a Feasibility Study of a New Intervention for Sexually Traumatized Women: Preliminary Evaluations of Efficacy and Outcome Measurements
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
- Being tested
- Take your sexuality back
- Medical subject headings
- Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take your sexuality backBehavioural
A 12 weeks group program.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group "Take your sexuality back" | Experimental | A 12 week group intervention Receives: Behavioral: Take your sexuality back |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Three month after end of treatment, when all quantitative results are analyzed and calculated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- University of Agder, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Hege Kersten, PhD, Study director, Research and Innovation Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147855
- Sponsor's protocol ID
- REK829297
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are sensitive and participants' anonymity cannot be guaranteed.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Your Sexuality Back - a Feasibility Study of a New Intervention for Sexually Traumatized Women: Preliminary Evaluations of Efficacy and Outcome Measurements
- ClinicalTrials.gov ID
- NCT07147855
- Acronym / sponsor ID
- REK829297
- Conditions
- Posttraumatic Stress Symptoms, Sexual Abuse, Sexual Trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- University of Agder, Norwegian University of Science and Technology
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group "Take your sexuality back" | Experimental | Behavioral: Take your sexuality backA 12 week group intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Acute suicidality.
- Serious substance abuse interfering with treatment
- Severe dissociative or psychotic disorders.
- Current life crisis interfering with treatment.
- Living in an abusive relationship. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take your sexuality backA 12 weeks group program. | Behavioural | Treatment group "Take your sexuality back" |
Primary outcome
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.
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.
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.
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.
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. Data are sensitive and participants' anonymity cannot be guaranteed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hege Kersten, PhD study director
Research and Innovation Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take your sexuality back in people with Posttraumatic Stress Symptoms and Sexual Abuse, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Idun Røseth, PhD (0047-41200462, IDUROE@sthf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD-symptoms and complex PTSD symptoms (time frame: From enrollment to 3 month after end of treatment (12 weeks treatment)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.