Resiliency Intervention for Patients With ALS and Their Care-Partners
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
recent (within ~2 months) of first appointment at Healey Center for diagnosis of ALS documented in Epic (based on recommendations from neurologists)
ability to understand the study and research protocol as determined by a standardized teach-back method of assessment
ability to communicate by writing, speaking, or assistive communication device
English speaking adults
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Resilient Together ALS
BehavioralThis intervention will teach resiliency and coping skills (mindfulness, meaning making, etc) to dyads soon after ALS diagnosis in order to manage distress associated with an ALS diagnosis. These sessions will take place over Zoom with both the person diagnosed with ALS and their primary informal caregiver.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: RT-ALS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Feasibility
Percentage of eligible ALS patient-caregiver dyads that participate in the intervention (\>70% acceptable; \>80% excellent).
Time frame
0 weeks2
Data Collection Feasibility
Percentage of dyads with no missing measures (\>70% acceptable; \>80% excellent)
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)3
Adherence Feasibility
Percentage of RT-ALS dyads that complete 4/6 sessions (\>70% acceptable; \>80% excellent)
Time frame
6 weeks4
Therapist Fidelity Feasibility
Percentage of adherence checklists completed; percentage of selected sessions (20%) with 100% adherence Fidelity Checks (\>70% acceptable; \>80% excellent).
Time frame
6 weeksSecondary outcomes
1
Hospital Anxiety and Depression Scale (HADS)
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.
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)2
The World Health Organization Quality of Life abbreviated (WHOQOL-BREF)
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.
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)3
Cognitive and Affective Mindfulness Scale (CAMS)
The Cognitive and Affective Mindfulness Scale (CAMS) measures dispositional mindfulness, higher values reflect higher levels of mindfulness. Maximum score: 48 Minimum score: 12.
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)4
Measure of Current Status Part A (MOCS-A)
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.
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)Other outcomes
1
FACIT Spiritual Well-Being Scale
The spiritual well-being of RT-ALS dyads reported at baseline and post-test as measured by the FACIT Spiritual Well-Being scale. Maximum score: 4 Minimum score: 0 on each sub scale. Higher scores indicate higher spiritual well-being.
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)2
Concern with Dying Scale
Measure of concern with dying in RT-ALS dyads reported at baseline and post-test as measured by the Concern with Dying Scale. Maximum score: 20 Minimum score: 6. Higher scores indicate higher levels of concern with death and dying.
Time frame
Pre-test (0 weeks) to Post-test (6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: