Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404684
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-30
Brief Title:
Psychological Treatment for Paraphilic Disorders
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg perceived obstacles to seeking care and how do they experience the treatment
The treatment addresses specific sexual problems It also addresses mental symptoms eg 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
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 eg perceived obstacles to seeking care and how do they experience the treatment
The treatment addresses specific sexual problems It also addresses mental symptoms eg 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 eg 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 eg 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 ClinicalTrialsgov identifier NCT05861752 please see the detailed description for an explanation of study procedures including assessments and meet the inclusionexclusion criteria below will be included in this project
Seven participants will be included with the main diagnosis of voyeurism exhibitionism andor 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 eg drug abuse or the development of a serious mental disorder
2 The treatment is deemed insufficient to meet the patients needs
Analytical plan SCED is useful to evaluate a newadapted treatment where the conditions being studied are rare andor 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 meanmedian value trends variability immediacy of effect and consistency Kratochwill et al 2013
Kendals TauTau 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
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 eg 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 ClinicalTrialsgov identifier NCT05861752 please see the detailed description for an explanation of study procedures including assessments and meet the inclusionexclusion criteria below will be included in this project
Seven participants will be included with the main diagnosis of voyeurism exhibitionism andor 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 eg drug abuse or the development of a serious mental disorder
2 The treatment is deemed insufficient to meet the patients needs
Analytical plan SCED is useful to evaluate a newadapted treatment where the conditions being studied are rare andor 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 meanmedian value trends variability immediacy of effect and consistency Kratochwill et al 2013
Kendals TauTau 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None