Paraphilic DisordersNCT06404684
Psychological Treatment for Paraphilic Disorders
A study testing Cognitive behavioral therapy (CBT) in people with Paraphilic Disorders, run by Region Stockholm at 1 site in Sweden.
Trial summary
The goal of this randomized study is to learn if a psychological intervention can treat help-seeking patients with paraphilic disorders. The main questions it aims to answer are: 1. Is psychological therapy helpful for the reduction of problematic sexual behaviors among patients with paraphilic disorders? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraphilic Disorders
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 4 Mar 2025to Jan 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants included in the study Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
- Deemed to benefit from CBT.
- Signed informed consent form for participation in the CBT treatment.
Who cannot join
- Mental condition that could negatively influence either the patient's health or the scientific aspects of the study, e.g., substance use syndrome, other ongoing psychotherapeutic treatment.
- Initiation of medication or change change of concurrent medication or dosage in the past three months regarding antidepressants, attention deficit hyperactivity disorder medication, cortisone, testosterone, naltrexone, testosterone blockers, or dopamine precursors. Smaller adjustments may in some cases be acceptable (assessed by study psychiatrist).
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, Stockholm County, 171 76
Josephine Savard, +46812373200, josephine.savard@regionstockholm.se
About this study
Official title: Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: the Evaluation of an Adapted Cognitive Behavioral Therapy (CBT) Manual for Paraphilic Disorders
The goal of this randomized study is to learn if a psychological intervention can treat help-seeking patients with paraphilic disorders.
The main questions it aims to answer are:
Read more
- Is psychological therapy helpful for the reduction of problematic sexual behaviors among patients with paraphilic disorders?
- Is psychological helpful for the reduction of psychiatric symptoms and risk factors for sexual violence and improving quality of life among patients with paraphilic disorders?
- How do patients with paraphilic disorders describe pathways to care (e.g. perceived obstacles to seeking care) and how do they experience the treatment?
The treatment addresses specific sexual problems. It also addresses mental symptoms (e.g. depression and anxiety). A psychologist provides the treatment face to face (on site or video). The aim is to finish the treatment within 12 weeks.
The patient will report symptoms on a daily basis. The patient will also be interviewed after completion of treatment. The investigator will pose questions such as "Was there anything that was experienced as particularly helpful in the treatment?", "Was there anything that was not helpful?". The investigator will also ask about treatment seeking behavior with questions such as "What kinds of resources would be helpful if they were available?"
Read the detailed description
The aim with this study is to systematically evaluate Cognitive Behavioral Therapy (CBT) for help-seeking patients with paraphilic disorders. The CBT-manual that will be used has been adapted to meet the current target group. The investigators will also interview the participants on how they experience the treatment and their pathways to care (e.g., perceived obstacles to seeking care).
- Is CBT effective for the reduction of problematic sexual behaviors among individuals with paraphilic disorders?
- Is CBT effective for the reduction of psychiatric comorbidity and risk factors for sexual violence and improving quality of life among individuals with paraphilic disorders?
- How do men with paraphilic disorders describe pathways to care (e.g., perceived obstacles to seeking care) and how do they experience the CBT treatment?
To answer questions a-b, the investigators will use a multiple baseline single-case experimental design (SCED) with phase A (baseline) and phase B (treatment). The participants will answer four questions daily, and additional questionnaires before phase A, before phase B, middle of phase B and at end of treatment.
Primary endpoint is the last reported measurement in phase B. The investigators will also have a follow-up measurement after 3 months.
To answer question c, qualitative interviews about perceived effect of treatment will be conducted. The interviews will transcribed and analyzed. The participants will also answer questionnaires addressing expectancy, perceived satisfaction, and negative effect of treatment.
Overall, a mixed method will be used to answer all three questions.
Procedures Patients seeking treatment at ANOVA (Karolinska University Hospital, Sweden) who is included in Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study (ClinicalTrials.gov identifier NCT05861752, please see the detailed description for an explanation of study procedures including assessments), and meet the inclusion/exclusion criteria below will be included in this project.
Seven participants will be included with the main diagnosis of voyeurism, exhibitionism and/or frotteurism, and seven participants with coercive-sexual sadism disorder. These two groups of seven participants will be treated and analyzed separately.
Termination criteria
- Conditions that are deemed to complicate the treatment (e.g., drug abuse or the development of a serious mental disorder).
- The treatment is deemed insufficient to meet the patient's needs.
Analytical plan SCED is useful to evaluate a new/adapted treatment where the conditions being studied are rare, and/or the group being studied is heterogeneous (Krasny-Pacini \& Evans, 2018).
A traditional power analysis is not feasible in SCED. Instead, power is achieved through repeated measurements. It has been recommended to include at least 3 participants, at least 3 (preferably 5) measurements per person at baseline, or at least three measurable behaviors. Moreover, randomization to at least 3 different lengths of the baseline phase has been suggested (Krasny-Pacini \& Evans, 2018) while others advocate at least 6 (Kratochwill et al., 2013).
Therefore, 7 participants will be randomized to 7 lengths of the baseline phase. Three different problematic sexual behaviors will be assessed daily (main outcome).
The data will be analyzed visually and descriptively to see changes in different phases: level lines (mean/median value), trends, variability, immediacy of effect and consistency (Kratochwill et al., 2013).
Kendal's Tau/Tau U will be used to analyze statistical differences in the variables between the phases.
Effect size on the outcome measures will be reported as standardized mean value.
Missing data will be handled by using the average of neighboring data points. Other outcome measures will be examined and reported descriptively and as percentage improvement.
- Conditions
- Paraphilic Disorders
- Being tested
- Cognitive behavioral therapy (CBT)
- Keywords
- paraphilic disorders
- Medical subject headings
- Paraphilic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
se above
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | The current CBT-manual is based on the CBT-manual used for hypersexual disorder, which was developed by ANOVA and evaluated scientifically, (Hallberg 2017, 2019, 2020), but has now been adapted to better meet the current target group. The CBT manual addresses specific sexual problematic behaviors but also contains interventions to deal with comorbidity (e.g. depression and anxiety). The treatment consists of 10 modules and is given by a psychologist (face to face or video). Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questions about sexual behaviors ("diary")
Three questions about time spent on problematic sexual behaviors or fantasies, level of desire and sex as coping.
Each question is scored 0-4. The main outcome measure is the total score of these three questions (0-12 points). A higher score indicates more severe problems.
Measured: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
Questions about sexual behaviors ("diary")
Three questions about time spent on problematic sexual behaviors or fantasies, level of desire and sex as coping.
Each question is scored 0-4. The three problem areas described under main outcome are handled as separate items and analyzed separately. A higher score indicates more severe problems.
Measured: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
Frotteuristic Disorder:Current Assessment Scale (FD: CAS)
The questionnaire will be used if the participant has a diagnosis of frotteuristic disorder. The questionnaire assesses frotteuristic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Voyeuristic Disorder: Current Assessment Scale (VD: CAS)
The questionnaire will be used if the participant has a diagnosis of voyeuristic disorder. The questionnaire assesses voyeuristic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Exhibitionistic Disorder: Current Assessment Scale (ED: CAS),
The questionnaire will be used if the participant has a diagnosis of exhibitionistic disorder. The questionnaire assesses exhibitionistic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Coercive Sexual Sadism Disorder: Current Assessment Scale (CSSD: CAS)
The questionnaire will be used if the participant has a diagnosis of Coercive Sexual Sadism Disorder. The questionnaire assesses coercive and sadistic (sexual) behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Secondary outcomes (11)
A question about general well-being
A question from general well-being schedule, scored 0-6. A higher score indicates more severe problems.
Measured: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
The Brief version of the Difficulties in emotional regulation scale (DERS-16)
Score range is 16-80. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Brunnsviken Brief Quality of Life Inventory (BBQ)
Score range is 0-48. A higher score indicates high quality of life
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Perceived Social Support (PSS-14)
Two subscales, one addressing support from family and the other from friends. Score range is 20-80. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Revised University of California, Los Angeles (UCLA) Loneliness Scale (RULS)
Score range is 20-80. A higher score indicates more loneliness.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
the rape questionnaire
Assessment of cognitive distortions about sex. Score range is 36-144. A higher score indicate more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Hypersexual Behavior Inventory (HBI)
a 19-item scale constructed to reflect the proposed Diagnostic and statistical manual of mental disorders, 5th edition criteria of hypersexual disorder. Score range is 19-95. A higher score indicates more severe problems.
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Credibility/Expectancy questionnaire (CEQ)
Two subscales with questions about treatment credibility and treatment outcome expectations. Four questions are rated on a scale of 1 to 9 (not at all to a lot), 2 questions are rated from 0% to 100%. A higher score indicate more credibility and expectancy.
Measured: Before treatment starts
Negative effect of treatment (NEQ)
It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances, as well as one open-ended question.
Measured: After completion of treatment (week 12)
Client Satisfaction Scale-8 (CSQ-8)
Score range is 8-32. A higher score indicates higher treatment satisfaction
Measured: After completion of treatment (week 12)
The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
Score range is 0-54. A higher score indicates more severe problems
Measured: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start4 Mar 2025
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Paraphilic DisordersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- we will use a multiple baseline single-case experimental design (SCED) with phase A (baseline) and phase B (treatment). Participants are randomized to different lengths of phase A; 15-21 days, so-called open randomization. Phase B is the CBT treatment. The B phase aims to last 84 days (12 weeks). Seven participants will be included with the main diagnosis of voyeurism, exhibitionism and/or frotteurism, and seven participants with coercive-sexual sadism disorder. The participants in each group will be randomized to seven lengths of phase A. These two groups of seven participants will be treated and analyzed separately.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Josephine Savard, Region Stockholm
- Investigators
- josephine Savard, Principal investigator, Anova, Karolinska University Hospital, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404684
- Sponsor's protocol ID
- 2024-01882-02
- Status last verified
- May 2026
- First submitted
- 30 Apr 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participants' data that underlie the results of the published article, after deidentification (text, tables, figures and appendices) might be available to researches who provide a methodically sound proposal.
Publications
Kratochwill TR, Horner RH, Levin JR, Machalicek W, Ferron J, Johnson A. Single-case intervention research design standards: Additional proposed upgrades and future directions. J Sch Psychol. 2023 Apr;97:192-216. doi: 10.1016/j.jsp.2022.12.002. Epub 2023 Feb 22.
PubMed 36914365Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607Hallberg J, Kaldo V, Arver S, Dhejne C, Piwowar M, Jokinen J, Oberg KG. Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study. J Sex Med. 2020 Oct;17(10):2039-2054. doi: 10.1016/j.jsxm.2020.07.018. Epub 2020 Sep 6.
PubMed 32900671Hallberg J, Kaldo V, Arver S, Dhejne C, Oberg KG. A Cognitive-Behavioral Therapy Group Intervention for Hypersexual Disorder: A Feasibility Study. J Sex Med. 2017 Jul;14(7):950-958. doi: 10.1016/j.jsxm.2017.05.004. Epub 2017 Jun 8.
PubMed 28602666Hallberg J, Kaldo V, Arver S, Dhejne C, Jokinen J, Oberg KG. A Randomized Controlled Study of Group-Administered Cognitive Behavioral Therapy for Hypersexual Disorder in Men. J Sex Med. 2019 May;16(5):733-745. doi: 10.1016/j.jsxm.2019.03.005. Epub 2019 Apr 5.
PubMed 30956109
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: the Evaluation of an Adapted Cognitive Behavioral Therapy (CBT) Manual for Paraphilic Disorders
- ClinicalTrials.gov ID
- NCT06404684
- Acronym / sponsor ID
- 2024-01882-02
- Conditions
- Paraphilic Disorders
- Keywords
- paraphilic disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 May 2024 (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 goal of this randomized study is to learn if a psychological intervention can treat help-seeking patients with paraphilic disorders.
The main questions it aims to answer are:
- Is psychological therapy helpful for the reduction of problematic sexual behaviors among patients with paraphilic disorders?
- Is psychological helpful for the reduction of psychiatric symptoms and risk factors for sexual violence and improving quality of life among patients with paraphilic disorders?
- How do patients with paraphilic disorders describe pathways to care (e.g. perceived obstacles to seeking care) and how do they experience the treatment?
The treatment addresses specific sexual problems. It also addresses mental symptoms (e.g. depression and anxiety). A psychologist provides the treatment face to face (on site or video). The aim is to finish the treatment within 12 weeks.
The patient will report symptoms on a daily basis. The patient will also be interviewed after completion of treatment. The investigator will pose questions such as "Was there anything that was experienced as particularly helpful in the treatment?", "Was there anything that was not helpful?". The investigator will also ask about treatment seeking behavior with questions such as "What kinds of resources would be helpful if they were available?"
Detailed description
The aim with this study is to systematically evaluate Cognitive Behavioral Therapy (CBT) for help-seeking patients with paraphilic disorders. The CBT-manual that will be used has been adapted to meet the current target group. The investigators will also interview the participants on how they experience the treatment and their pathways to care (e.g., perceived obstacles to seeking care).
- Is CBT effective for the reduction of problematic sexual behaviors among individuals with paraphilic disorders?
- Is CBT effective for the reduction of psychiatric comorbidity and risk factors for sexual violence and improving quality of life among individuals with paraphilic disorders?
- How do men with paraphilic disorders describe pathways to care (e.g., perceived obstacles to seeking care) and how do they experience the CBT treatment?
To answer questions a-b, the investigators will use a multiple baseline single-case experimental design (SCED) with phase A (baseline) and phase B (treatment). The participants will answer four questions daily, and additional questionnaires before phase A, before phase B, middle of phase B and at end of treatment.
Primary endpoint is the last reported measurement in phase B. The investigators will also have a follow-up measurement after 3 months.
To answer question c, qualitative interviews about perceived effect of treatment will be conducted. The interviews will transcribed and analyzed. The participants will also answer questionnaires addressing expectancy, perceived satisfaction, and negative effect of treatment.
Overall, a mixed method will be used to answer all three questions.
Procedures Patients seeking treatment at ANOVA (Karolinska University Hospital, Sweden) who is included in Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study (ClinicalTrials.gov identifier NCT05861752, please see the detailed description for an explanation of study procedures including assessments), and meet the inclusion/exclusion criteria below will be included in this project.
Seven participants will be included with the main diagnosis of voyeurism, exhibitionism and/or frotteurism, and seven participants with coercive-sexual sadism disorder. These two groups of seven participants will be treated and analyzed separately.
Termination criteria
- Conditions that are deemed to complicate the treatment (e.g., drug abuse or the development of a serious mental disorder).
- The treatment is deemed insufficient to meet the patient's needs.
Analytical plan SCED is useful to evaluate a new/adapted treatment where the conditions being studied are rare, and/or the group being studied is heterogeneous (Krasny-Pacini \& Evans, 2018).
A traditional power analysis is not feasible in SCED. Instead, power is achieved through repeated measurements. It has been recommended to include at least 3 participants, at least 3 (preferably 5) measurements per person at baseline, or at least three measurable behaviors. Moreover, randomization to at least 3 different lengths of the baseline phase has been suggested (Krasny-Pacini \& Evans, 2018) while others advocate at least 6 (Kratochwill et al., 2013).
Therefore, 7 participants will be randomized to 7 lengths of the baseline phase. Three different problematic sexual behaviors will be assessed daily (main outcome).
The data will be analyzed visually and descriptively to see changes in different phases: level lines (mean/median value), trends, variability, immediacy of effect and consistency (Kratochwill et al., 2013).
Kendal's Tau/Tau U will be used to analyze statistical differences in the variables between the phases.
Effect size on the outcome measures will be reported as standardized mean value.
Missing data will be handled by using the average of neighboring data points. Other outcome measures will be examined and reported descriptively and as percentage improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- we will use a multiple baseline single-case experimental design (SCED) with phase A (baseline) and phase B (treatment). Participants are randomized to different lengths of phase A; 15-21 days, so-called open randomization. Phase B is the CBT treatment. The B phase aims to last 84 days (12 weeks). Seven participants will be included with the main diagnosis of voyeurism, exhibitionism and/or frotteurism, and seven participants with coercive-sexual sadism disorder. The participants in each group will be randomized to seven lengths of phase A. These two groups of seven participants will be treated and analyzed separately.
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | Behavioral: Cognitive behavioral therapy (CBT)The current CBT-manual is based on the CBT-manual used for hypersexual disorder, which was developed by ANOVA and evaluated scientifically, (Hallberg 2017, 2019, 2020), but has now been adapted to better meet the current target group. The CBT manual addresses specific sexual problematic behaviors but also contains interventions to deal with comorbidity (e.g. depression and anxiety). The treatment consists of 10 modules and is given by a psychologist (face to face or video). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants included in the study Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
- Deemed to benefit from CBT.
- Signed informed consent form for participation in the CBT treatment.
Key exclusion criteria (2 listed)
- Mental condition that could negatively influence either the patient's health or the scientific aspects of the study, e.g., substance use syndrome, other ongoing psychotherapeutic treatment.
- Initiation of medication or change change of concurrent medication or dosage in the past three months regarding antidepressants, attention deficit hyperactivity disorder medication, cortisone, testosterone, naltrexone, testosterone blockers, or dopamine precursors. Smaller adjustments may in some cases be acceptable (assessed by study psychiatrist).
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 |
|---|---|---|
| Cognitive behavioral therapy (CBT)se above | Behavioural | Cognitive behavioral therapy (CBT) |
Primary outcome
Questions about sexual behaviors ("diary")
Time frame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
Three questions about time spent on problematic sexual behaviors or fantasies, level of desire and sex as coping. Each question is scored 0-4. The main outcome measure is the total score of these three questions (0-12 points). A higher score indicates more severe problems.
Questions about sexual behaviors ("diary")
Time frame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
Three questions about time spent on problematic sexual behaviors or fantasies, level of desire and sex as coping. Each question is scored 0-4. The three problem areas described under main outcome are handled as separate items and analyzed separately. A higher score indicates more severe problems.
Frotteuristic Disorder:Current Assessment Scale (FD: CAS)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
The questionnaire will be used if the participant has a diagnosis of frotteuristic disorder. The questionnaire assesses frotteuristic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Voyeuristic Disorder: Current Assessment Scale (VD: CAS)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
The questionnaire will be used if the participant has a diagnosis of voyeuristic disorder. The questionnaire assesses voyeuristic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Exhibitionistic Disorder: Current Assessment Scale (ED: CAS),
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
The questionnaire will be used if the participant has a diagnosis of exhibitionistic disorder. The questionnaire assesses exhibitionistic behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
Coercive Sexual Sadism Disorder: Current Assessment Scale (CSSD: CAS)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
The questionnaire will be used if the participant has a diagnosis of Coercive Sexual Sadism Disorder. The questionnaire assesses coercive and sadistic (sexual) behaviors. The questionnaire is scored 0-32. A higher score indicates more severe problems.
11 secondary outcomes
A question about general well-being
Time frame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
The Brief version of the Difficulties in emotional regulation scale (DERS-16)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Perceived Social Support (PSS-14)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Revised University of California, Los Angeles (UCLA) Loneliness Scale (RULS)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
the rape questionnaire
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Hypersexual Behavior Inventory (HBI)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
Credibility/Expectancy questionnaire (CEQ)
Time frame: Before treatment starts
Negative effect of treatment (NEQ)
Time frame: After completion of treatment (week 12)
Client Satisfaction Scale-8 (CSQ-8)
Time frame: After completion of treatment (week 12)
The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
Time frame: start of randomization (phase A), start of treatment (phase B), in the middle of treatment (week 6), at end of treatment (week 12), and follow-up 3 months after treatment.
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 4 Jun 2026.
- Results publication: PubMed 36914365Kratochwill TR, Horner RH, Levin JR, Machalicek W, Ferron J, Johnson A. Single-case intervention research design standards: Additional proposed upgrades and future directions. J Sch Psychol. 2023 Apr;97:192-216. doi: 10.1016/j.jsp.2022.12.002. Epub 2023 Feb 22.
- Results publication: PubMed 29253607Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- Results publication: PubMed 32900671Hallberg J, Kaldo V, Arver S, Dhejne C, Piwowar M, Jokinen J, Oberg KG. Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study. J Sex Med. 2020 Oct;17(10):2039-2054. doi: 10.1016/j.jsxm.2020.07.018. Epub 2020 Sep 6.
- Results publication: PubMed 28602666Hallberg J, Kaldo V, Arver S, Dhejne C, Oberg KG. A Cognitive-Behavioral Therapy Group Intervention for Hypersexual Disorder: A Feasibility Study. J Sex Med. 2017 Jul;14(7):950-958. doi: 10.1016/j.jsxm.2017.05.004. Epub 2017 Jun 8.
- Results publication: PubMed 30956109Hallberg J, Kaldo V, Arver S, Dhejne C, Jokinen J, Oberg KG. A Randomized Controlled Study of Group-Administered Cognitive Behavioral Therapy for Hypersexual Disorder in Men. J Sex Med. 2019 May;16(5):733-745. doi: 10.1016/j.jsxm.2019.03.005. Epub 2019 Apr 5.
- Individual participant dataSharing planned: Yes. Individual participants' data that underlie the results of the published article, after deidentification (text, tables, figures and appendices) might be available to researches who provide a methodically sound proposal.
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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.
josephine Savard principal investigator
Anova, Karolinska University Hospital, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) in people with Paraphilic Disorders, 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 3 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 4 Jun 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 josephine savard, MD, PhD (0046812373200, josephine.savard@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questions about sexual behaviors ("diary") (time frame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.). The study lists 6 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 NCT06404684, which also lists 5 linked publications.
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 4 Jun 2026.