A randomized-controlled pilot trial of telemedicine-delivered cognitive-behavioral therapy tailored for interstitial cystitis/bladder pain syndrome

Abstract

Abstract Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating urologic pain condition with few treatment advances in the past 25 years. Individuals with IC/BPS often experience significant psychological distress, which worsens symptoms and functioning. To date, there have been no large-scale, randomized controlled trials (RCTs) of comprehensive psychological interventions for IC/BPS. We conducted a 2:1 RCT of an 8-session patient-informed cognitive-behavioral therapy (CBT) intervention designed for IC/BPS for reducing pain-related symptoms and improving quality of life, delivered through telemedicine. Individuals with IC/BPS (N = 78) were randomized to receive either 8 weeks of CBT specifically designed for IC/BPS (n = 52) or an attention control condition (n = 26). Urologic symptoms (Genitourinary Pain Index, GUPI), pain-related symptoms, affective distress, and quality of life were evaluated before, immediately after, and 3 months posttreatment. Both conditions reported significant but similar reductions (P = 0.922) in the a priori primary outcome of genitourinary symptoms at posttreatment (GUPI reduction = 6.6 vs 4.8, for CBT and control, respectively) and long-term follow-up (8.1 vs 6.6, for CBT and control). However, the CBT group had significantly greater improvement in Patient Global Impression of Change (PGIC) scores and was significantly more likely to be treatment responders (PGIC ≥ 6) (37% vs 8%, P = 0.019 for CBT and control), with a large relative effect size (OR = 6.68). A subgroup analysis of CBT recipients showed that responders (PGIC 6) displayed significant reductions in genitourinary symptoms (P = 0.023), pain intensity (P = 0.027), and pain interference (P = 0.013) posttreatment. Telemedicine-delivered pain CBT for IC/BPS shows promise for improving outcomes, and this trial demonstrates the need for larger RCTs of CBT for IC/BPS.