Stepped care targeting psychological distress in head and neck cancer and lung cancer patients: a randomized, controlled trial.

BACKGROUND This study aimed to evaluate the efficacy of stepped care (SC) targeting psychological distress in head and neck cancer (HNC) and lung cancer (LC) patients. PATIENTS AND METHODS Patients with untreated distress [Hospital Anxiety and Depression Scale (HADS; HADS-D > 7, HADS-A > 7, or HADS-total > 14)] were randomized to SC (n = 75) or care-as-usual (CAU) (n = 81). SC consisted of watchful waiting, guided self-help, problem-solving therapy, and psychotherapy and/or psychotropic medication. The primary outcome measure was the HADS; secondary outcome measures were recovery rate, EORTC QLQ-C30, QLQ-HN35/QLQ-LC13, and IN-PATSAT32. Measures were assessed at baseline, after completion of care, and at 3, 6, 9, and 12 months follow-up. Linear mixed models, t-tests, and effect sizes (ES) were used to assess group differences. RESULTS Patients with untreated distress were randomized to SC (n = 75) or care-as-usual (CAU) (n = 81). The course of psychological distress was better after SC compared with CAU (HADS-total, P = 0.005; HADS-A, P = 0.046; HADS-D, P = 0.007). The SC group scored better post-treatment (HADS-total, ES = 0.56; HADS-A, ES = 0.38; HADS-D, ES = 0.64) and at 9 months follow-up (HADS-total, ES = 0.42 and HADS-A, ES = 0.40). The recovery rate post-treatment was 55% after SC compared with 29% after CAU (P = 0.002), and 46% and 37% at 12 months follow-up (P = 0.35). Within SC, 28% recovered after watchful waiting, 34% after guided self-help, 9% after problem-solving therapy, and 17% after psychotherapy and/or psychotropic medication. The effect of SC was stronger for patients with a depressive or anxiety disorder compared with patients without such a disorder (HADS-total, P = 0.001; HADS-A, P = 0.003; HADS-D, P = 0.041). CONCLUSIONS SC is effective and speeds up recovery among HNC and LC patients with untreated psychological distress. TRIAL REGISTRATION Netherlands Trial Register (NTR1868).