Amyotrophic lateral sclerosis Nervous System Diseases Motor neuron disease
Conditions
Interventions
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,
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 – th
Sponsors
Amyotrophic Lateral Sclerosis Association (ALSA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Co-morbid active psychiatric condition present 2. Capacity to consent is diminished 3. Low levels of literacy would deem the intervention too demanding 4. Neurological or significant healthcare complications 5. Active addiction to state-altering substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Ireland
Contacts
Public ContactTom Burke
Outcome results
None listed