An Online Mindfulness Intervention for People With ALS and Their Caregivers

NCT03095989 | Completed

• 1 other identifier: IRB14-3695
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The psychological impact of ALS on both patients and caregivers is high and affects their quality of life (QOL). However, there is minimal research about psychological interventions to improve QOL in the ALS scientific literature. Recent advances in clinical treatments aimed at improving the health of people with chronic disorders are based on the concept of mindfulness. Mindfulness can be defined as a flexible state of mind resulting from the simple act of actively noticing new things, as opposed to mindlessness, the human tendency to operate on" autopilot". Preliminary data suggests that mindfulness may promote a better QOL for people with ALS and their caregivers. The investigators also found that a mindful attitude was associated with slower disease progression. This project's goal is to develop an innovative, web-based online mindfulness training program and intervention, customized for people with ALS and their primary caregivers. It is an active learning intervention, with cognitive exercises and lectures that increase participants' mindfulness. The efficacy of this program for improving QOL, and for reducing anxiety and depression in people with ALS and their caregivers, will be tested with a randomized clinical trial. Assessments immediately post-treatment as well as 3 and 6 months after recruitment will be conducted, comparing subjects undergoing the mindfulness intervention to a control group.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

mindfulness

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  ALS-Specific Quality of Life-Revised (ALSSQoL-R; Simmons et al., 2006)

  4-6 weeks after recruitment

Secondary Outcomes (7)

• Depression and anxiety

  Baseline (T1); one month after recruitment (T2); three months after recruitment (T3); six months after recruitment (T4)

• Quality of Life

  Baseline (T1); three months after recruitment (T3); six months after recruitment (T4)

• The patient's perception of physical impairment

  Baseline (T1); one month after recruitment (T2); three months after recruitment (T3); six months after recruitment (T4)

• Physician-assessed physical impairment

  Baseline (T1); three months after recruitment (T3); six months after recruitment (T4)Baseline (T1); 4-6 weeks after recruitment (T2); three months after recruitment (T3); six months after recruitment (T4)

• Vital capacity (VC)

  Baseline (T1); three months after recruitment (T3); six months after recruitment (T4)Baseline (T1); 4-6 weeks after recruitment (T2); three months after recruitment (T3); six months after recruitment (T4)

Other Outcomes (1)

• Mindfulness

  Baseline (T1); 4-6 weeks after recruitment (T2); three months after recruitment (T3); six months after recruitment (T4)

Study Arms (2)

Mindfulness

EXPERIMENTAL

Subjects in the intervention group will participate in an online mindfulness program developed in the first phase of the study, in addition to standard clinical care.

Behavioral: Mindfulness

Waiting list

NO INTERVENTION

Participants from the control group will be placed on a waiting list and will receive the standard care, that they would receive if not in the study. They will be assessed according to the assessment schedule, exactly as subjects in the intervention group. After the last assessment (six months after recruitment), they will receive the option to enter the mindfulness program.

Interventions

Mindfulness BEHAVIORAL

The structure of the protocol incorporates key features of Langer's mindfulness theory. Many of the tasks and exercises have demonstrated increased mindfulness in the general population and have been modified to incorporate ALS-specific exercises that make sense from patients and caregivers' points of view. The intervention provides easily understood multimedia (video and written) presentations of the framework of mindfulness and the aims of the planned tasks. The general structure of the protocol mixes different mindfulness elements; for every week there is a specific topic examined in depth. These topics are: Attention to variability; Positive and negative events; Unpredictability; Sense Making; and Novelty seeking / novelty producing. The overall duration of the protocol is 5 weeks.

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite, probable, probable laboratory-supported, or possible ALS by revised El-Escorial criteria (Brooks, Miller, Swash, \& Munsat, 2000).
• Must have the physical ability, with or without adaptive devices, to use a computer and access the Internet.
• A forced vital capacity of 50% or greater than the predicted value, measured within 30 days of enrollment. If impaired bulbar function compromises accurate pulmonary function testing as determined by the study neurologist, then a forced vital capacity as low as 40% of predicted is permitted. If taken, stable doses of anti-anxiety or antidepressant medications for 30 days before study entry, and during the study from the T1 to the T2 time point.
• Must have the physical ability to use a computer and access the Internet.

You may not qualify if:

• Scores on the Edinburgh Cognitive Assessment (ECAS) within 90 days of study entry, that meet criteria for mild frontotemporal dysfunction (either cognitive or behavioral)
• Significant cognitive impairment or significant uncontrolled psychiatric disease (for example, schizophrenia, bipolar disorder), in the opinion of the study neurologist.
• Unsuitable for the study as determined by the study neurologist.
• Regular meditation or participation in a mindfulness program in past 6 months.
• Unwillingness to participate in the study
• Unsuitable for the study as determined by the clinical staff. For example, the clinical staff may consider inappropriate a caregiver who showed no real interest toward the care process or showed signs of severe mental health problems.

Sponsors & Collaborators

• Harvard University: lead
• ALS Association: collaborator
• Milton S. Hershey Medical Center: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

• Pagnini F, Phillips D, Bosma CM, Reece A, Langer E. Mindfulness as a Protective Factor for the Burden of Caregivers of Amyotrophic Lateral Sclerosis Patients. J Clin Psychol. 2016 Jan;72(1):101-11. doi: 10.1002/jclp.22235. Epub 2015 Oct 20.

  PMID: 26485696 BACKGROUND

• Pagnini F, Phillips D, Bosma CM, Reece A, Langer E. Mindfulness, physical impairment and psychological well-being in people with amyotrophic lateral sclerosis. Psychol Health. 2015;30(5):503-17. doi: 10.1080/08870446.2014.982652. Epub 2014 Nov 26.

  PMID: 25361013 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ellen Langer, PhD

  Professor of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Fellow

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2017
• Study Start: January 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)