Group interventions for amyotrophic lateral sclerosis caregivers

Not Applicable

• Conditions: Amyotrophic lateral sclerosis; Nervous System Diseases; Motor neuron disease

• Registration Number: ISRCTN53226941
• Lead Sponsor: Amyotrophic Lateral Sclerosis Association (ALSA)

Brief Summary

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31542756 (added 23/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Last Update Posted: 29 October 2019
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 75

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. Depression assessed using Patient Health Questionnaire- 9 (PHQ-9: total score; Kroenke, Spitzer, & Williams, 2001)<br> 2. Anxiety assessed using General Anxiety Disorder Questionnaire-7 (GAD-7: total score; Spitzer, Kroenke, Williams, & Löwe, 2006)<br> 3. Psychological distress assessed using Hospital Anxiety and Depression Scale (HADS: anxiety subscale, depression subscale, and total score; Zigmond & Snaith, 1983)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Questionnaires will be administered to participants as a baseline before the intervention, immediately following the intervention, and again after 3 months:<br> 1. Caregiver burden assessed using Zarit Burden Interview (ZBI: total score; Zarit, Reever, & Bach-Peterson, 1980)<br> 2. Quality of life assessed using McGill Quality of Life Questionnaire (McGill: total score; Cohen, Mount, Strobel, & Bui, 1995)<br>