Randomized controlled trial of an individual blended cognitive behavioral therapy to reduce psychological distress among distressed colorectal cancer survivors: The COloRectal canceR distrEss reduCTion trial.

ABSTRACT

OBJECTIVE: Colorectal cancer survivors (CRCS) often experience high levels of distress. The objective of this randomized controlled trial was to evaluate the effect of blended cognitive behavior therapy (bCBT) on distress severity among distressed CRCS. METHODS: CRCS (targeted N = 160) with high distress (Distress Thermometer ≥5) between 6 months and 5 years post cancer treatment were randomly allocated (11 ratio) to receive bCBT, (14 weeks including five face-to-face, and three telephone sessions and access to interactive website), or care as usual (CAU). Participants completed questionnaires at baseline (T0), four (T1) and 7 months later (T2). Intervention participants completed bCBT between T0 and T1. The primary outcome analyzed in the intention-to-treat population was distress severity (Brief Symptom Inventory; BSI-18) immediately post-intervention (T1). RESULTS: 84 participants were randomized to bCBT (n = 41) or CAU (n = 43). In intention-to-treat analysis, the intervention significantly reduced distress immediately post-intervention (-3.86 points, 95% CI -7.00 to -0.73) and at 7 months post-randomization (-3.88 points, 95% CI -6.95 to -0.80) for intervention compared to CAU. Among secondary outcomes, at both time points, depression symptoms, anxiety symptoms, cancer worry, and cancer-specific distress were significantly lower in the intervention arm. Self-efficacy scores were significantly higher. Overall treatment satisfaction was high (7.4/10, N = 36) and 94% of participants would recommend the intervention to other colorectal cancer patients. CONCLUSIONS: The blended COloRectal canceR distrEss reduCTion intervention seems an efficacious psychological intervention to reduce distress severity in distressed CRCS. Yet uncertainty remains about effectiveness because fewer participants than targeted were included in this trial. TRIAL REGISTRATION Netherlands Trial Register NTR6025.