PartnerNCT07434219
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
A study testing A Group Based Psychoeducational Intervention in people with Partner, run by Region Stockholm at 1 site in Sweden.
Trial summary
The overall aim of this feasibility study is to investigate the clinical characteristics of female partners of male child sexual abuse material (CSAM) offenders and to evaluate the feasibility of a novel psychoeducational group intervention designed to address their specific needs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Partner
- What is being tested?
- A Group Based Psychoeducational Intervention
- 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 siteSweden
- Study dates
- 25 Aug 2026to 1 Mar 2029
- 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
- Female partners of male CSAM offenders
- A score of ≥ 3 points on the General Health Questionnaire 12 (GHQ-12) at screening and an affirmative response to the follow-up question: Do you feel that your reduced psychological well-being is primarily related to your partner's CSAM offenses?
- Ability to understand spoken and written Swedish
- Willingness to participate in the intervention
- Signed written informed consent form.
Who cannot join
- The partner has committed hands-on sexual offenses against children
- Presence of a severe mental disorder (e.g., psychosis or major depression) requiring immediate treatment 8) Psychological or cognitive conditions that could compromise participant safety or study integrity (e.g., intellectual disability).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
ANOVA, Karolinska university hospital
Stockholm
Josephine Savard, PhD, +46812373200, josephine.savard@regionstockholm.se
Josephine Savard, PhD
About this study
Official title: A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders: A Non-Randomized Feasibility Study
The overall aim of this feasibility study is to investigate the clinical characteristics of female partners of male child sexual abuse material (CSAM) offenders and to evaluate the feasibility of a novel psychoeducational group intervention designed to address their specific needs.
The main questions it aims to answer are:
Read more
- What are the clinical characteristics of female partners of male CSAM offenders?
- Is a psychoeducational group intervention for female partners of male CSAM offenders feasible?
- Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?
Feasibility will be assessed in terms of 1) recruitment, time from recruitment to offered intervention and completed sessions 2) expectancy of treatment improvement, credibility, and satisfaction 3) acceptability and relevance 4) occurrence of negative effects 5) changes in depression- and anxiety symptoms and psychological well-being 6) changes in daily functioning.
Read the detailed description
Sexual offences against children online, including child sexual abuse material (CSAM), is a violation against human rights and is a growing public health problem all over the world. Relatives of CSAM offenders, inclusive partners, have shown to suffer a range of negative consequences. Several studies have identified a lack of adequate mental health support and emphasize the need for targeted interventions to help individuals process and manage the psychological impact and challenges associated with being a relative to a CSAM offender.
The main questions it aims to answer are:
- What are the clinical characteristics of female partners of male CSAM offenders? Guiding questions:
- Do individuals in this population meet criteria for any psychiatric diagnoses?
- What types of trauma-related symptoms are present within the population?
- What is the distribution of the degree of suicide risk (low, medium, high) within the population?
- Is a psychoeducational group intervention for female partners of male CSAM offenders feasible? Guiding questions:
- To what extent is it feasible to recruit enough participants within a reasonable (12 months) timeframe?
- To what extent is it feasible to offer the group intervention within a reasonable (4 months) timeframe?
- To what extent do participants complete the intended number of sessions?
- How do participants perceive the treatment and are they satisfied with it?
- How do participants experience the intervention?
- Are there any negative effects associated with participation in the intervention?
- Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?
Guiding questions:
- Are there any changes in depression- and anxiety symptoms and psychological well-being?
- Are there any changes in daily functioning?
The study will be conducted at ANOVA, Karolinska University Hospital, Sweden. ANOVA is a multidisciplinary clinic and research unit within sexual medicine, andrology and trans medicine. The clinic has many years of clinical experience in assessment, treatment, and research of pedophilia and other sexual medicine conditions. ANOVA operates PrevenTell, a national helpline and chat service for unwanted sexuality, which is the primary means of reaching the target group.
Potentially eligible participants will be invited to ANOVA at Karolinska University Hospital for an on-site assessment with the research team, including a psychiatrist. During this visit, participants will receive verbal information about the study, written participant information will be provided, and informed consent will be obtained. Participants will then complete questionnaires and other study measurements.
The psychoeducational group intervention will include female partners (n=20), and consists of a total of five sessions, each lasting approximately 90 minutes. To clarify the outcome time frame, the first session is considered Day 1. The sessions are held weekly. The group manual is based on our clinical experience of working with relatives, previous research from other countries, and the results of a qualitative study carried out at ANOVA, Karolinska University Hospital (Adebahr et al, 2025.).
The purpose of the intervention is to increase partners' ability to identify, understand, and manage the emotional, social, and practical stresses associated with being a partner of a CSAM offender; to reduce experiences of isolation and shame through the sharing of experiences with others in similar situations; and to provide increased knowledge about sexual problems and available treatments.
An individual follow-up visit with a therapist will take place at the clinic or via video once the group sessions have been completed.
Data analysis Demographic and clinical characteristics of the participants will be presented descriptively. Quantitative data will be analyzed using descriptive statistics, including the calculation of means and standard deviations or interquartile ranges. Pre- and post- intervention assessments will be conducted to examine changes in secondary outcome measures, providing insight into potential effects of the intervention.
Qualitative data will be analyzed using qualitative content analysis with a descriptive manifest approach.
- Conditions
- Partner
- Being tested
- A Group Based Psychoeducational Intervention
- Keywords
- intervension, partner, pedophilia
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Group Based Psychoeducational InterventionBehavioural
The purpose of the intervention is to increase the partners' ability to identify, understand, and manage the emotional, social, and practical stresses associated with being a partner of a CSAM offender; reduce the experience of isolation and shame through sharing experiences with people with similar experiences; and provide increased knowledge about sexual problems and treatment. Each session has a clear agenda with a defined theme and includes opportunities for reflection and the sharing of experiences. The session themes are: 1) Crisis and emotional impact, 2) Emotional responses over time, 3) Relationships and social impact, 4) Practical impact and sexual issues, 5) Summary and future perspectives.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Experimental | The psychoeducational group intervention consists of a total of five sessions, each lasting approximately 90 minutes. The sessions are held weekly at the clinic or via video using a health care application and are facilitated by two experienced therapists. Each group will include approximately five participants. Receives: Behavioral: A Group Based Psychoeducational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Study process log will assess recruitment pathway (number of screened individuals, number of individuals who decline, number of individuals excluded and on what grounds)
Criteria for success:
- 15-20 participants recruited within 12 moths.
Measured: 12 months from study start
Recruitment and study procedures feasibility
Study process log will assess time taken to recruit and time from recruitment to offered intervention
Criteria for success:
Recruited participants may be offered the group intervention within 4 months.
Measured: 4 months from enrollment
Study procedures feasibility
Study process log will assess number of completed sessions
Criteria for success:
- At least 80% of participants complete a minimum of 3 sessions.
Measured: Day 29 after treatment start (Post-intervention, session 5)
Secondary outcomes (9)
Posttraumatic Stress Disorder Checklist (version 5) (PCL-5)
revised from the original PCL, is a self-report measure developed to assess PTSD symptoms in accordance with the diagnostic criteria outlined in the DSM-V. It consists of 20 items to measure symptom severity, with options "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely," that correspond to scores of 1-5. A total symptom severity score (range - 0-80) can be obtained by summing the scores of all 20 items. It is suggested that cutoff score between 31-33 is indicative of probable PTSD across samples
Measured: screening visit
psychiatric symptoms according to DSM-5 criteria
a structured evaluation of psychiatric symptoms according to DSM-5 criteria. The interview is conducted by a psychiatrist.
Measured: screening visit
Credibility/Expectancy Questionnaire (CEQ)
A scale for measuring treatment expectancy and rationale credibility to use in clinical outcome studies.
Expectancy is measured with a range of 0-100% and credibility are measured with a range of 1-9. Higher scores indicate greater treatment credibility.
Measured: Day 15 (after session 2)
Client Satisfaction Questionnaire (CSQ-8)
a scale for measuring of patient satisfaction with the service received. It consists of 8 questions and satisfaction is measured with a range of 8-32. Higher scores indicate greater satisfaction.
Criteria for success: At least 80% of participants score 26 points or higher
Measured: Day 29 (Post-intervention, session 5)
Acceptability and relevance
Will be evaluated qualitatively through written anonymous open-ended questions after each visit.
Measured: After each session (Day 1, Day 8, Day 15, Day 22, Day 29)
The General Health Questionnaire 12 (GHQ -12)
measures self-rated general psychological health in the general population. It consists of 12 items, each item has four response options and is scored using the binary method (0, 0, 1, 1) with maximum score of 12. A high score indicates a potential risk of psychiatric problems. Individuals who score 3 or higher are defined as having reduced well-being.
Measured: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Negative Effects Questionnaire (NEQ)
The NEQ consists of 32 items assessing the occurrence of negative or unwanted effects associated with psychological treatment. For each item, participants first indicate whether the effect occurred (yes/no). If endorsed, participants rate how negatively the effect impacted them on a 5-point Likert scale ranging from 0 to 4 (0 = not at all, 4 = extremely).
Severity ratings therefore range from 0 to 4 per item, with higher scores indicating greater negative impact. When severity ratings are summed across all 32 items, the total NEQ severity score ranges from 0 to 128, with higher total scores reflecting a greater number and/or severity of negative effects.
In addition, participants indicate whether each negative effect is attributed primarily to the intervention or to other circumstances.
NEQ data will be analyzed descriptively, including the number of endorsed negative effects, severity ratings, and attribution.
Measured: Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Work and Social Adjustment Scale (WSAS)
a brief, self-report measure designed to assess functional impairment attributable to an identified problem or mental health condition. It consists of five items evaluating the impact on work, home management, social leisure, private leisure, and close relationships. Each item is rated on a 9-point Likert scale ranging from 0 (no impairment) to 8 (very severe impairment), yielding a total score between 0 and 40.
Measured: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
Score range is 0-54. A higher score indicates more severe problems
Measured: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start25 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PartnerStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434219
- Sponsor's protocol ID
- 2025-07025-01
- Other IDs
- 2025
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized personal data may be shared with researchers both within and outside the EU/EEA, provided that the research proposals are methodologically sound. Relevant data-sharing agreements will be established in accordance with applicable legislation.
Publications
Adebahr R, Savard J, Akerstedt U, Bystrom M, Sparre C, Hadding C, Gorts Oberg K, Jokinen J. Healthcare needs and barriers to care among female partners of male suspects of child sexual abuse material offences in Sweden: a qualitative interview study. Front Psychiatry. 2025 Oct 22;16:1618162. doi: 10.3389/fpsyt.2025.1618162. eCollection 2025.
PubMed 41200223
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders: A Non-Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT07434219
- Acronym / sponsor ID
- 2025-07025-01
- Conditions
- Partner
- Keywords
- intervension, partner, pedophilia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 25 Feb 2026 (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.
The overall aim of this feasibility study is to investigate the clinical characteristics of female partners of male child sexual abuse material (CSAM) offenders and to evaluate the feasibility of a novel psychoeducational group intervention designed to address their specific needs.
The main questions it aims to answer are:
- What are the clinical characteristics of female partners of male CSAM offenders?
- Is a psychoeducational group intervention for female partners of male CSAM offenders feasible?
- Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?
Feasibility will be assessed in terms of 1) recruitment, time from recruitment to offered intervention and completed sessions 2) expectancy of treatment improvement, credibility, and satisfaction 3) acceptability and relevance 4) occurrence of negative effects 5) changes in depression- and anxiety symptoms and psychological well-being 6) changes in daily functioning.
Detailed description
Sexual offences against children online, including child sexual abuse material (CSAM), is a violation against human rights and is a growing public health problem all over the world. Relatives of CSAM offenders, inclusive partners, have shown to suffer a range of negative consequences. Several studies have identified a lack of adequate mental health support and emphasize the need for targeted interventions to help individuals process and manage the psychological impact and challenges associated with being a relative to a CSAM offender.
The main questions it aims to answer are:
- What are the clinical characteristics of female partners of male CSAM offenders? Guiding questions:
- Do individuals in this population meet criteria for any psychiatric diagnoses?
- What types of trauma-related symptoms are present within the population?
- What is the distribution of the degree of suicide risk (low, medium, high) within the population?
- Is a psychoeducational group intervention for female partners of male CSAM offenders feasible? Guiding questions:
- To what extent is it feasible to recruit enough participants within a reasonable (12 months) timeframe?
- To what extent is it feasible to offer the group intervention within a reasonable (4 months) timeframe?
- To what extent do participants complete the intended number of sessions?
- How do participants perceive the treatment and are they satisfied with it?
- How do participants experience the intervention?
- Are there any negative effects associated with participation in the intervention?
- Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?
Guiding questions:
- Are there any changes in depression- and anxiety symptoms and psychological well-being?
- Are there any changes in daily functioning?
The study will be conducted at ANOVA, Karolinska University Hospital, Sweden. ANOVA is a multidisciplinary clinic and research unit within sexual medicine, andrology and trans medicine. The clinic has many years of clinical experience in assessment, treatment, and research of pedophilia and other sexual medicine conditions. ANOVA operates PrevenTell, a national helpline and chat service for unwanted sexuality, which is the primary means of reaching the target group.
Potentially eligible participants will be invited to ANOVA at Karolinska University Hospital for an on-site assessment with the research team, including a psychiatrist. During this visit, participants will receive verbal information about the study, written participant information will be provided, and informed consent will be obtained. Participants will then complete questionnaires and other study measurements.
The psychoeducational group intervention will include female partners (n=20), and consists of a total of five sessions, each lasting approximately 90 minutes. To clarify the outcome time frame, the first session is considered Day 1. The sessions are held weekly. The group manual is based on our clinical experience of working with relatives, previous research from other countries, and the results of a qualitative study carried out at ANOVA, Karolinska University Hospital (Adebahr et al, 2025.).
The purpose of the intervention is to increase partners' ability to identify, understand, and manage the emotional, social, and practical stresses associated with being a partner of a CSAM offender; to reduce experiences of isolation and shame through the sharing of experiences with others in similar situations; and to provide increased knowledge about sexual problems and available treatments.
An individual follow-up visit with a therapist will take place at the clinic or via video once the group sessions have been completed.
Data analysis Demographic and clinical characteristics of the participants will be presented descriptively. Quantitative data will be analyzed using descriptive statistics, including the calculation of means and standard deviations or interquartile ranges. Pre- and post- intervention assessments will be conducted to examine changes in secondary outcome measures, providing insight into potential effects of the intervention.
Qualitative data will be analyzed using qualitative content analysis with a descriptive manifest approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: A Group Based Psychoeducational InterventionThe psychoeducational group intervention consists of a total of five sessions, each lasting approximately 90 minutes. The sessions are held weekly at the clinic or via video using a health care application and are facilitated by two experienced therapists. Each group will include approximately five participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female partners of male CSAM offenders
- A score of ≥ 3 points on the General Health Questionnaire 12 (GHQ-12) at screening and an affirmative response to the follow-up question: Do you feel that your reduced psychological well-being is primarily related to your partner's CSAM offenses?
- Ability to understand spoken and written Swedish
- Willingness to participate in the intervention
- Signed written informed consent form.
Key exclusion criteria (2 listed)
- The partner has committed hands-on sexual offenses against children
- Presence of a severe mental disorder (e.g., psychosis or major depression) requiring immediate treatment 8) Psychological or cognitive conditions that could compromise participant safety or study integrity (e.g., intellectual disability).
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 |
|---|---|---|
| A Group Based Psychoeducational InterventionThe purpose of the intervention is to increase the partners' ability to identify, understand, and manage the emotional, social, and practical stresses associated with being a partner of a CSAM offender; reduce the experience of isolation and shame through sharing experiences with people with similar experiences; and provide increased knowledge about sexual problems and treatment. Each session has a clear agenda with a defined theme and includes opportunities for reflection and the sharing of experiences. The session themes are: 1) Crisis and emotional impact, 2) Emotional responses over time, 3) Relationships and social impact, 4) Practical impact and sexual issues, 5) Summary and future perspectives. | Behavioural | Psychoeducation |
Primary outcome
Recruitment feasibility
Time frame: 12 months from study start
Study process log will assess recruitment pathway (number of screened individuals, number of individuals who decline, number of individuals excluded and on what grounds) Criteria for success: - 15-20 participants recruited within 12 moths.
Recruitment and study procedures feasibility
Time frame: 4 months from enrollment
Study process log will assess time taken to recruit and time from recruitment to offered intervention Criteria for success: Recruited participants may be offered the group intervention within 4 months.
Study procedures feasibility
Time frame: Day 29 after treatment start (Post-intervention, session 5)
Study process log will assess number of completed sessions Criteria for success: - At least 80% of participants complete a minimum of 3 sessions.
9 secondary outcomes
Posttraumatic Stress Disorder Checklist (version 5) (PCL-5)
Time frame: screening visit
psychiatric symptoms according to DSM-5 criteria
Time frame: screening visit
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Day 15 (after session 2)
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Day 29 (Post-intervention, session 5)
Acceptability and relevance
Time frame: After each session (Day 1, Day 8, Day 15, Day 22, Day 29)
The General Health Questionnaire 12 (GHQ -12)
Time frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Negative Effects Questionnaire (NEQ)
Time frame: Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Work and Social Adjustment Scale (WSAS)
Time frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
Time frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
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 2026.
- Background: PubMed 41200223Adebahr R, Savard J, Akerstedt U, Bystrom M, Sparre C, Hadding C, Gorts Oberg K, Jokinen J. Healthcare needs and barriers to care among female partners of male suspects of child sexual abuse material offences in Sweden: a qualitative interview study. Front Psychiatry. 2025 Oct 22;16:1618162. doi: 10.3389/fpsyt.2025.1618162. eCollection 2025.
- Individual participant dataSharing planned: Yes. Pseudonymized personal data may be shared with researchers both within and outside the EU/EEA, provided that the research proposals are methodologically sound. Relevant data-sharing agreements will be established in accordance with applicable legislation.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Group Based Psychoeducational Intervention in people with Partner, run by Region Stockholm at 1 site in Sweden.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 Sweden. 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 Ulrika Akerstedt (+46812373200, ulrika.akerstedt@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 12 months from study start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434219, which also lists 1 linked publication.
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 2026.