Group interventions for amyotrophic lateral sclerosis caregivers

INTERVENTION: The trial is a 2‐arm assessment of effectiveness and efficacy of group‐based interventions (Experimental Treatment Arm 1: CBT; Experimental Treatment Arm 2: Mindfulness‐Based Stress Reduction [MBSR]) with a treatment as usual (TAU) control arm. The trial will be conducted and reported according to CONSORT guidelines (Schulz, Altman, & Moher, 2010). The participant information sheet will explain the evidence‐based approach of the interventions for mild to moderate anxiety and depression, as well as the nature of the treatment as usual group. Each programme will be briefly described. It will be explained that, in order to evaluate which programme works better, caregivers will be randomly assigned. It will also be explained that participants may withdraw from treatment at any time, and that opting not to participate in the research programme will not affect receipt of services, for them or the person with ALS. Participants will be provided with contact details of members of the research team should they wish to ask any further questions, and participants will be given time to read the information at their leisure. Participants are then asked on the day of consenting if they have further queries or questions. For the purpose of the CONSORT flow diagram, and in the interest of improving future research, participants who discontinue their engagement with the research will be provided with the opportunity to express the reason for this. Intervention Arm 1: Building Better Caregivers (BBC) For treatment arm 1, the researchers will run the Building Better Caregivers (BBC; Lorig et al., 2012) programme, as developed by Stanford University. It is described in brief below. In accordance with CBT‐based programmes, there is a treatment manual for facilitators to follow – this ensures the standardised delivery of the programme. There is an accompanying workbook in accordance with CBT practice which will incorporate CONDITION: Amyotrophic lateral sclerosis ; Nervous System Diseases ; Motor neuron disease SECONDARY OUTCOME: ; Questionnaires will be administered to participants as a baseline before the intervention, immediately following the intervention, and again after 3 months:; 1. Caregiver burden assessed using Zarit Burden Interview (ZBI: total score; Zarit, Reever, & Bach‐Peterson, 1980); 2. Quality of life assessed using McGill Quality of Life Questionnaire (McGill: total score; Cohen, Mount, Strobel, & Bui, 1995); INCLUSION CRITERIA: 1. Caregivers will be included regardless of relationship type (spouse/child/parent), though the patient must have a diagnosis of ALS over another Motor Neuron Disease 2. Caregivers will be aged 18 years and over for consent purposes PRIMARY OUTCOME: ; Questionnaires will be administered to participants as a baseline before the intervention, immediately following the intervention, and again after 3 months. The primary aim of the study is to indicate the extent to which an intervention group may lead to improvements in caregiver anxiety and depression (effectiveness), and if these improvements were maintained at 3 months follow‐up (efficacy). To do that, the following measures are considered primary outcomes:; 1. Depression assessed using Patient Health Questionnaire‐ 9 (PHQ‐9: total score; Kroenke, Spitzer, & Williams, 2001); 2. Anxiety assessed using General Anxiety Disorder Questionnaire‐7 (GAD‐7: total score; Spitzer, Kroenke, Williams, & Löwe, 2006); 3. Psychological distress assessed using Hospital Anxiety and Depression Scale (HADS: anxiety subscale, depression subscale, and total score; Zigmond & Snaith, 1983);