Clinical trial NCT06404684: Psychological Treatment for Paraphilic Disorders
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paraphilic Disorders
Keywords: paraphilic disorders
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2024-05-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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?"

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Questions about sexual behaviors ("diary")
timeFrame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
measure: Questions about sexual behaviors ("diary")
timeFrame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
measure: Frotteuristic Disorder:Current Assessment Scale (FD: CAS)
timeFrame: 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.
measure: Voyeuristic Disorder: Current Assessment Scale (VD: CAS)
timeFrame: 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.
measure: Exhibitionistic Disorder: Current Assessment Scale (ED: CAS),
timeFrame: 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.
measure: Coercive Sexual Sadism Disorder: Current Assessment Scale (CSSD: CAS)
timeFrame: 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:
measure: A question about general well-being
timeFrame: From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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.
measure: The Brief version of the Difficulties in emotional regulation scale (DERS-16)
timeFrame: 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.
measure: Brunnsviken Brief Quality of Life Inventory (BBQ)
timeFrame: 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.
measure: Perceived Social Support (PSS-14)
timeFrame: 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.
measure: Revised University of California, Los Angeles (UCLA) Loneliness Scale (RULS)
timeFrame: 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.
measure: the rape questionnaire
timeFrame: 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.
measure: Hypersexual Behavior Inventory (HBI)
timeFrame: 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.
measure: Credibility/Expectancy questionnaire (CEQ)
timeFrame: Before treatment starts
measure: Negative effect of treatment (NEQ)
timeFrame: After completion of treatment (week 12)
measure: Client Satisfaction Scale-8 (CSQ-8)
timeFrame: After completion of treatment (week 12)
Other outcomes:
measure: Qualitative interview (research question c)
timeFrame: After completion of treatment (week 12)
measure: Quality assurance of the manual after each module
timeFrame: After each treatment module (i.e., 10 times under a time-period of 12 weeks)
Locations:
city: Stockholm
country: Sweden
facility: ANOVA, Karolinska university hospital
Study officials:
affiliation: Anova, Karolinska University Hospital, Stockholm, Sweden
name: josephine Savard
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.