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| Name | Class |
|---|---|
| Catholic University of the Sacred Heart | OTHER |
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The psychological impact of ALS on patients and caregivers is high, significantly affecting their quality of life (QOL). Despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve QOL.
The efficacy of mindfulness-based treatments for the improvement of QOL was previously demonstrated by the investigator's group. Despite preliminary positive results, treatment efficacy tends to weaken over time. The investigators believe that a robust solution to maintain efficacy is to maximize the utilization of technology and emerging social platforms, establishing a "mindful community" to promote and continuously reinforce mindfulness.
This project's primary aims are 1) to develop a "mindful" online community of people with ALS and their caregivers, and 2) to test its efficacy in QOL improvement. This two-part intervention consists of 1) optimizing the investigator's prior e-learning platform with a three-week program including cognitive exercises, videos and lectures to increase participants' mindfulness; and 2) involving participants in a "mindfulness community" within a social sharing forum. Assessments will be performed before and immediately post-treatment as well as 3- and 6-months post-program comparing subjects undergoing the intervention to a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | Three-week online mindfulness course followed by one-month social community online interaction. |
|
| Mindful Learning | Active Comparator | Three-week online mindful learning course followed by one-month social community online interaction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | Online non-meditation mindfulness program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) - For PALS (Persons with ALS) | The ALSSQOL-SF is a 20 item quality of life instrument for patients. It has a 0-10 rating scale with higher scores denoting higher QOL. | 3 months |
| World Health Organization Quality of Life (Brief) WHO-QoL BREF - For Caregivers of PALS | The WHO-QoL BREF is a 26 item quality of life scale covering four domains of QOL. Each item is scored from 1-5 with higher response employing a higher quality of life. Items are scored from 1-5 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | The HADS measures anxiety and depression in a general medical population of patients. It has seven items each for depression and anxiety sub scales. Scoring ranges from 0 to 3, with 3 denoting the highest anxiety or depression level. A total sub scale score of over 8 out of 21 denotes considerable symptoms of either. | 3 weeks, 3 months, 6 months after joining |
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Inclusion Criteria:
For the ALS patients
For the caregivers
Exclusion criteria
- Using shared devices. Patients and caregivers should have their own devices.
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Langer, PhD | Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard University | Cambridge | Massachusetts | 02138 | United States |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Mindful Learning |
| Behavioral |
Online learning program |
|
| Functional Status | Self-Administered Functional Rating Scale Revised | 3 weeks, 3 months, 6 months after joining |
| Zarit Burden Interview | The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden. A score of 17 or more has been considered high burden. | 3 weeks, 3 months, 6 months after joining |
| ALS Specific QOL Short Form Quality of Life (ALSSQOL-SF) | The ALSSQOL-SF is a 20 item quality of life instrument for patients. It has a 0-10 rating scale with higher scores denoting higher QOL. | 3 weeks, 3 months, 6 months after joining |
| World Health Organization Quality of Life (Brief) WHO-QoL BREF | The WHO-QoL BREF is a 16 item quality of life scale covering four domains of QOL. Each item is scored from 1-5 with higher response employing a higher quality of life. | 3 weeks, 3 months, 6 months after joining |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |