Psychological Treatment for Paraphilic Disorders

NCT06404684 | Recruiting

• 1 other identifier: 2024-01882-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Paraphilic Disorders

Keywords

paraphilic disorders

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (2)

• Qualitative interview (research question c)

  After completion of treatment (week 12)

• Quality assurance of the manual after each module

  After each treatment module (i.e., 10 times under a time-period of 12 weeks)

Study Arms (1)

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).

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Cognitive behavioral therapy (CBT) BEHAVIORAL

se above

Cognitive behavioral therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

ANOVA, Karolinska university hospital

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

Related Publications (5)

• 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.

  PMID: 36914365 RESULT

• 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.

  PMID: 29253607 RESULT

• 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.

  PMID: 32900671 RESULT

• 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.

  PMID: 28602666 RESULT

• 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.

  PMID: 30956109 RESULT

MeSH Terms

Conditions

Paraphilic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• josephine Savard

  Anova, Karolinska University Hospital, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

josephine savard, MD, PhD

CONTACT

0046812373200; josephine.savard@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 8, 2024
• Study Start: March 4, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication and ending ten years from study completion.
• 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.

Locations

SE (1)