Cognitive behavioural therapy and quality of life in psychologically distressed patients with amyotrophic lateral sclerosis and their caregivers: Results of a prematurely stopped randomized controlled trial.

Our objective was to compare the effects of cognitive behavioural therapy (CBT) and usual care (UC) on quality of life (QoL) in psychologically distressed patients with ALS and their caregivers. We conducted a multicentre randomized controlled trial (RCT). In 16 weeks, patient-carer pairs received five to 10 CBT sessions plus usual care (UC) or UC alone. Outcome measures were SF-36 Mental Component Summary (MCS), ALSAQ-40 Emotional Functioning (EF), Hospital Anxiety and Depression Scale (HADS) and Caregiver Strain Index (CSI). Assessments took place at baseline, four, seven and 10 months. The steering committee decided to stop the trial prematurely and analyse the data due to: 1) slow recruitment (15 patients over 42 months); and 2) the low demand for joint patient-carer CBT sessions. Caregivers, however, expressed an unanticipated demand for individual psychological support. Patients' ALSAQ-40-EF and caregivers' SF-36-MCS were significantly better in CBT than UC (p < 0.05). CSI was significantly lower in the CBT than the UC (p < 0.05). In conclusion, CBT might be beneficial to patients and caregivers. The stringent eligibility criteria limited participation rate and consequently the generalizability of results. Future studies should further examine the impact of CBT interventions for patients with ALS and their caregivers.

RCT Entities:   Population Interventions Outcomes