Psychological Treatment for Paraphilic Disorders
- Conditions
- Paraphilic Disorders
- Interventions
- Behavioral: Cognitive behavioral therapy (CBT)
- Registration Number
- NCT06404684
- Lead Sponsor
- Region Stockholm
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cognitive behavioral therapy (CBT) 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).
- Primary Outcome Measures
Name Time Method Frotteuristic Disorder:Current Assessment Scale (FD: CAS) 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.
Questions about sexual behaviors ("diary") 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.Exhibitionistic Disorder: Current Assessment Scale (ED: CAS), 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) 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.
Voyeuristic Disorder: Current Assessment Scale (VD: CAS) 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.
- Secondary Outcome Measures
Name Time Method A question about general well-being From date of randomization until the date of end of treatment (week 12), and a follow-up assessement 3 months after end of treatment. A question from general well-being schedule, scored 0-6. A higher score indicates more severe problems.
Brunnsviken Brief Quality of Life Inventory (BBQ) 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. Score range is 0-48. A higher score indicates high quality of life
Client Satisfaction Scale-8 (CSQ-8) After completion of treatment (week 12) Score range is 8-32. A higher score indicates higher treatment satisfaction
Hypersexual Behavior Inventory (HBI) 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. 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.
The Brief version of the Difficulties in emotional regulation scale (DERS-16) 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. Score range is 16-80. A higher score indicates more severe problems.
Perceived Social Support (PSS-14) 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. Two subscales, one addressing support from family and the other from friends. Score range is 20-80. A higher score indicates more severe problems.
Revised University of California, Los Angeles (UCLA) Loneliness Scale (RULS) 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. Score range is 20-80. A higher score indicates more loneliness.
Hospital Anxiety and Depression Scale (HADS) 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. Score range is 0-21. A higher score indicates more severe problems.
the rape questionnaire 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. Assessment of cognitive distortions about sex. Score range is 36-144. A higher score indicate more severe problems.
Credibility/Expectancy questionnaire (CEQ) Before treatment starts 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.
Negative effect of treatment (NEQ) After completion of treatment (week 12) 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.
Trial Locations
- Locations (1)
ANOVA, Karolinska university hospital
🇸🇪Stockholm, Sweden