FULLSENSE-An Online Intervention Program for Adults Reporting Sexual Difficulties: a Two-Armed Randomized Controlled Pilot Trial Protocol

BACKGROUND: Sexuality is a key aspect of human life, significantly influencing health, well‐being, and quality of life. Sexual dysfunction may occur throughout the sexual response cycle and is commonly associated with psychological distress and dissatisfaction. Online interventions have proven effective in promoting sexual health by providing accessible, private, and evidence‐based support. Cognitive‐behavioral therapy (CBT) and mindfulness‐based methods show promise in treating sexual dysfunction, enhancing function, increasing satisfaction, and reducing distress. Embracing a comprehensive and positive, pleasure‐inclusive view of sexuality is vital for supporting sexual health and overall well‐being. This study presents the protocol for a feasibility pilot randomized controlled trial evaluating FULLSENSE, an 8‐week, guided online intervention designed to improve sexual well‐being in adults reporting sexual dysfunction. METHODS: A two‐arm, parallel, open‐label design, with the waiting‐list control group receiving treatment as usual will be conducted. Participants (N = 70) meeting eligibility criteria will be randomly assigned to the FULLSENSE intervention or a waiting‐list control group. Primary outcomes will assess the intervention's acceptability, usability, and feasibility. Secondary outcomes will evaluate preliminary efficacy in improving sexual satisfaction, functioning, pleasure, and reducing sexual distress, while cognitive and neurophysiological assessments will allow us to explore functional connectivity and correlates of implicit cognition and interoception. Data collection will include self‐reported measures and neurophysiology assessments for a nested sample. RESULTS: Findings will provide insights into the feasibility and preliminary efficacy of FULLSENSE, informing future large‐scale trials. If successful, this intervention may facilitate access to sexual health care and support individuals experiencing sexual distress. CONCLUSION: The FULLSENSE feasibility pilot trial promises valuable insights into an accessible, evidence‐based online intervention for sexual dysfunction, potentially contributing to digital sexual health solutions. The findings of the forthcoming studies will support the intervention's implementation and ultimately facilitate sexual healthcare access and support.