Psychological Treatment for Paraphilic Disorders

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.

• A question about general well-being [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Before treatment starts]
• Negative effect of treatment (NEQ) [Срок оценки: After completion of treatment (week 12)]
• Client Satisfaction Scale-8 (CSQ-8) [Срок оценки: After completion of treatment (week 12)]
• The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S) [Срок оценки: 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.]