Adebahr Roberth, Görts Öberg Katarina, Rahm Christoffer, Byström Markus, Sparre Charlotte, Desai Boström Adrian E, Bottai Matteo, Jokinen Jussi, Savard Josephine
Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden.
ANOVA, Karolinska University Hospital, Stockholm, Sweden.
Front Psychiatry. 2024 Aug 9;15:1448196. doi: 10.3389/fpsyt.2024.1448196. eCollection 2024.
Sexual Interest in Children (SIC) is a major risk factor for sexual offending, yet clinical trials are sparse. The present protocol outlines a randomized controlled trial (RCT) that aims to investigate the effectiveness of fluoxetine and Cognitive Behavioral Therapy (CBT) in help-seeking men with SIC.
Adult men contacting the Swedish telephone helpline PrevenTell are screened for inclusion and invited to further assessment on site. One hundred and eleven men with SIC (defined as DSM-5 pedophilic disorder or hebephilia) will be randomized (1:1:1 ratio) to receive one of three interventions for 14 weeks: (1) an internet-administered psychoeducational program (iPP), (2) iPP and the addition of fluoxetine 20-40 mg or (3) iPP and the addition of internet-administered CBT (iCBT). Exclusion criteria include severe psychiatric illness, contraindicating treatment and an elevated risk of committing hands-on sexual offences. Symptom intensity is assessed at baseline, pre-treatment, every other week for 12 weeks, and post treatment. The primary outcome measure is the Sexual Interest in Children: Current Assessment Scale (SIC: CAS) that quantifies sexual behaviors associated with SIC as well as perceived distress and impairment. Secondary outcomes include measures of dynamic risk-factors for committing sexual offences.
The data collected during the initial 20 months of recruitment were analyzed to predict the required number of individuals to be screened and estimate the probable length of the data collection phase. As of March 2022 to November 2023, 146 men have called PrevenTell and disclosed a sexual interest in minors. Following pre-screening, 110 men were excluded from participation in the trial. Current SSRI therapy was the primary reason for exclusion (n = 24; 22%), followed by an elevated risk of committing hands-on sexual offences (n = 14; 13%). Among the 31 men who underwent the screening procedure on site, 26 were allocated to either iPP, iPP+fluoxetine, or iPP+iCBT. The recruitment rate indicates that the trial will be concluded within the pre-estimated timeframe.
This is the first RCT of treatment with SSRI and iCBT in a population of help-seeking men with SIC. The significance of this trial and its methodological strengths and limitations are discussed.
对儿童的性兴趣（SIC）是性犯罪的一个主要风险因素，但临床试验却很稀少。本方案概述了一项随机对照试验（RCT），旨在调查氟西汀和认知行为疗法（CBT）对有SIC且寻求帮助的男性的有效性。
联系瑞典电话求助热线PrevenTell的成年男性会接受纳入筛查，并被邀请到现场进行进一步评估。111名有SIC的男性（定义为DSM-5恋童癖障碍或青春期前恋态）将被随机分组（比例为1:1:1），接受三种干预措施之一，为期14周：（1）一个由互联网管理的心理教育项目（iPP），（2）iPP并加用20 - 40毫克氟西汀，或（3）iPP并加用由互联网管理的CBT（iCBT）。排除标准包括严重精神疾病、禁忌治疗以及实施直接性犯罪的风险升高。在基线、治疗前、治疗的12周内每隔一周以及治疗后评估症状强度。主要结局指标是对儿童的性兴趣：当前评估量表（SIC: CAS），该量表量化与SIC相关的性行为以及感知到的痛苦和损害。次要结局包括性犯罪动态风险因素的测量指标。
对招募最初20个月期间收集的数据进行了分析，以预测所需筛查的个体数量，并估计数据收集阶段的可能时长。截至2022年3月至2023年11月，146名男性拨打了PrevenTell热线并透露了对未成年人的性兴趣。经过初步筛查，110名男性被排除在试验之外。当前的SSRI治疗是排除的主要原因（n = 24；22%），其次是实施直接性犯罪的风险升高（n = 14；13%）。在31名在现场接受筛查程序的男性中，26名被分配到iPP、iPP + 氟西汀或iPP + iCBT组。招募率表明该试验将在预先估计的时间范围内完成。
这是第一项针对有SIC且寻求帮助的男性群体进行SSRI和iCBT治疗的随机对照试验。讨论了该试验的意义及其方法学上的优势和局限性。
