Psychological Treatment for Paraphilic Disorders

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:

1. Is psychological therapy helpful for the reduction of problematic sexual behaviors among patients with paraphilic disorders?
2. 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?
3. 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?"

Study Overview

• Status: Recruiting
• Conditions: Paraphilic Disorders
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy (CBT)

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).

1. Is CBT effective for the reduction of problematic sexual behaviors among individuals with paraphilic disorders?
2. 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?
3. 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

1. Conditions that are deemed to complicate the treatment (e.g., drug abuse or the development of a serious mental disorder).
2. 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 Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: josephine savard, MD, PhD; Phone Number: 0046812373200; Email: josephine.savard@regionstockholm.se

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 76
      • Recruiting
      • ANOVA, Karolinska university hospital
      • Contact: Josephine Savard; Phone Number: +46812373200; Email: josephine.savard@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants included in the study Paraphilic Disorders and Other Conditions With Risk for Sexual Violence: a Case-control Study
2. Deemed to benefit from CBT.
3. Signed informed consent form for participation in the CBT treatment.

Exclusion Criteria:

1. 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.
2. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Behavioral: Cognitive behavioral therapy (CBT); se above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A question about general well-being	A question from general well-being schedule, scored 0-6. A higher score indicates more severe problems.	From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
Hospital Anxiety and Depression Scale (HADS)	Score range is 0-21. A higher score indicates more severe problems.	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 Brief version of the Difficulties in emotional regulation scale (DERS-16)	Score range is 16-80. A higher score indicates more severe problems.	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	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.	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.	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.	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.	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.	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.	After completion of treatment (week 12)
Client Satisfaction Scale-8 (CSQ-8)	Score range is 8-32. A higher score indicates higher treatment satisfaction	After completion of treatment (week 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interview (research question c)	A 60 min interview questions such as "Can you tell us about the treatment you received", "What do you take with you from the treatment?", "Was there anything that you experienced as particularly helpful in the treatment?", "Was there anything that was not helpful?"	After completion of treatment (week 12)
Quality assurance of the manual after each module	Include questions such as "how relevant and helpful did you find the current module on a scale of 1-5 (1 = not at all helpful, 3 = neither, 5 = very helpful), How much time did you spend working on the material (reading and doing homework)?	After each treatment module (i.e., 10 times under a time-period of 12 weeks)

Collaborators and Investigators

• Sponsor: Region Stockholm
• Investigators: Principal Investigator: josephine Savard, Anova, Karolinska University Hospital, Stockholm, Sweden

Publications and helpful links

General 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.
• Krasny-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.
• Hallberg 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.
• Hallberg 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.
• Hallberg 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: paraphilic disorders
• Additional Relevant MeSH Terms: Mental Disorders; Paraphilic Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 2024-01882-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Immediately following publication and ending ten years from study completion.
• IPD Sharing Access Criteria: Researches who provide a methodically sound proposal. Proposals should be directed to the PI. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No