An interventional study of A Group Based Psychoeducational Intervention in Partner, sponsored by Region Stockholm. Recruiting at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Region Stockholm · Not applicable, Interventional, and Supportive care
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:
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.
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:
Is a psychoeducational group intervention for female partners of male CSAM offenders feasible?
Guiding questions:
Guiding questions:
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.
Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: A Group Based Psychoeducational Intervention
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 29 after treatment start (Post-intervention, session 5)
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 29 (Post-intervention, session 5)
Acceptability and relevance
Will be evaluated qualitatively through written anonymous open-ended questions after each visit.
Time frame: 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.
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)
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.
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)
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.
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)
Score range is 0-54. A higher score indicates more severe problems
Time frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: 10 years after completion of the study.
Access criteria: A written proposal describing the planned analyses must be submitted to josephine.savard@regionstockholm.se, and a data-sharing agreement must be signed prior to any data transfer
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
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