Resiliency Intervention for Patients With ALS and Their Care-Partners
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)Emotional Distress
- Registration Number
- NCT06968468
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.
- Detailed Description
The goal of this study to refine our proposed intervention Resilient Together ALS (RT-ALS) through an open pilot. The investigators will deliver an open pilot of the intervention (N= up to10 dyads; up to 20 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place over Zoom, with participants recruited from the Massachusetts General Hospital's Sean M. Healey and AMG Center for ALS. Study clinicians will deliver 6, 30-45 minute sessions over Zoom. All participants will complete measures at baseline and after completion of the program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback on the intervention.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- patient with ALS with comorbid terminal diagnosis or severe mental health disorder that limits ability to participate (by self-report, as determined by our clinical team);
- cognitive disorder that limits ability to participate (per neurologist)
- inability or unwillingness to use live video technology (will teach any dyads who have low technology literacy how to use live video technology)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Recruitment Feasibility 0 weeks Percentage of eligible ALS patient-caregiver dyads that participate in the intervention (\>70% acceptable; \>80% excellent).
Adherence Feasibility 6 weeks Percentage of RT-ALS dyads that complete 4/6 sessions (\>70% acceptable; \>80% excellent)
Treatment Satisfaction 6 weeks Percentage of dyads who score above the midpoint on Client Satisfaction Questionnaire (\> 70% acceptable; \> 80% excellent)
Credibility and Expectancy Pre-test (0 weeks) Percentage of dyads who score above midpoint on the Credibility/Expectancy Questionnaire (\> 70% acceptable; \> 80% excellent)
Adverse Events 6 weeks None or minimal adverse events
Data Collection Feasibility Pre-test (0 weeks) to Post-test (6 weeks) Percentage of dyads with no missing measures (\>70% acceptable; \>80% excellent)
Therapist Fidelity Feasibility 6 weeks Percentage of adherence checklists completed; percentage of selected sessions (20%) with 100% adherence Fidelity Checks (\>70% acceptable; \>80% excellent).
- Secondary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale (HADS) Pre-test (0 weeks) to Post-test (6 weeks) Report of emotional distress at baseline and post-test as measured by the Hospital Anxiety and Depression Scale (HADS). Minimum score: 0 Maximum score: 21 for both the Anxiety and Depression sub-scales. Higher scores indicate higher levels of reported anxiety and depression.
The World Health Organization Quality of Life abbreviated (WHOQOL-BREF) Pre-test (0 weeks) to Post-test (6 weeks) Quality of life of RT-ALS dyads reported at both baseline and post-test as measured by the World Health Organization Quality of Life - abbreviated measure (WHOQOL-BREF). Maximum score: 20 Minimum score: 4 on each domain. Higher scores indicate higher quality of life.
Cognitive and Affective Mindfulness Scale (CAMS) Pre-test (0 weeks) to Post-test (6 weeks) The Cognitive and Affective Mindfulness Scale (CAMS) measures dispositional mindfulness, higher values reflect higher levels of mindfulness. Maximum score: 48 Minimum score: 12.
Measure of Current Status Part A (MOCS-A) Pre-test (0 weeks) to Post-test (6 weeks) Assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Maximum score: 52 Minimum score: 0; higher scores indicate a greater perceived ability to employ adaptive coping strategies.
Multidimensional Scale of Perceived Social Support (MSPSS) Pre-test (0 weeks) to Post-test (6 weeks) A measure of perceived social support. Higher scores indicate greater perceived social support. Minimum score: 1 Maximum score: 7.
Dyadic Coping Inventory (DCI) Pre-test (0 weeks) to Post-test (6 weeks) Assesses self-reported coping behaviors when dyad faces stressors. Higher scores reflect more adaptive coping. Maximum score: 35 Minimum score: 1.
The Meaning in Life Questionnaire (MLQ) Pre-test (0 weeks) to Post-test (6 weeks) A measure of sense of meaning and purpose in life. A higher score on the presence of meaning items indicates higher presence of meaning. A higher score on the search for meaning items indicates greater active search for meaning. Maximum score: 70 Minimum score: 10.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States