An Online Mindfulness Intervention for People With ALS and Their Caregivers

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

Interventions

BEHAVIORAL

Mindfulness

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.

Sponsors & Collaborators

• ALS Association

  collaborator OTHER

• Milton S. Hershey Medical Center

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Harvard University

  lead OTHER

Principal Investigators

• Ellen Langer, PhD · Professor of Psychology

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2019-02-28

Completion

2019-02-28

Countries

• United States

Study Locations