An Online Mindfulness Intervention for People With ALS and Their Caregivers

Quality of Life in people with ALS is not related to physical function, but is related to
psychological, existential, and support factors. ALS caregivers demonstrate considerable
burden and low QOL. It has been proposed by the investigators that it is time for the ALS
field to develop "best practices" that use psychological intervention to improve QOL,
reducing psychological distress in people with ALS and their caregivers. A disease that is as
inexorably progressive and physically devastating as ALS also inevitably has an immense
psychological impact on caregivers, both at the time of diagnosis and throughout the course
of the disease. Yet, there is scant research on psychological interventions for ALS patients
and caregivers.

Over 35 years of research demonstrate that mindfulness-based interventions comprise some of
the most promising behavioral treatments in QOL improvement for people with chronic
disorders.This work is based on socio-cognitive aspects of mindfulness, conceptualized as
having a flexible state of mind that incorporates active engagement in the present and being
sensitive to context and perspective. In over 35 years of research it has been shown that a
higher state of mindfulness correlates with an improved QOL. In addition, mindfulness may
lead to an improvement in some physiological as well as psychological measures. The
literature on mindfulness in other disorders, combined with preliminary data on mindfulness
in ALS patients and their caregivers, provides a strong evidence-based platform for proposing
a careful study of the effects of mindfulness on psychological and physiological measures of
ALS patients and their caregivers. The investigators conducted an exploratory investigation
on a large sample (100+) of people with ALS about the influence of mindfulness on QOL and the
course of the disease. The investigators found that mindfulness predicted positive QOL and
psychological well-being, reducing anxiety and depression. That was quite expected. However,
another finding was that mindfulness positively influenced the changes in physical symptoms:
subjects with higher mindfulness experienced a slower progression of the disease, as measured
by the self- administered ALS Functional Rating Scale (SA-ALSFRS). Furthermore, mindfulness
was a significant predictor of positive QOL and psychological well-being in ALS caregivers,
with a protective effect against anxiety and depression.

Fifty (50) participants with ALS, together with each subject's primary caregiver (i.e., an
expected overall sample of 100 subjects), will be directly recruited from the Hershey Medical
Center ALS Clinic at Penn State University. Participants will sign IRS-approved informed
consent documents. Both patients and caregivers may be recruited even if a component of the
dyad (patient-caregiver) opts not to join the study (i.e. patients and caregivers alone may
be recruited). ALS patient-caregiver couples will be considered as a single subject for
randomisation purposes (meaning that both the patient and the caregiver are randomly
allocated to the same group). Subjects will be randomized into two groups (employing true
randomization from atmospheric noise, www.random.org): an intervention group and a control
group. Subjects in the intervention group will participate in the online mindfulness program,
in addition to standard clinical care.

The intervention for each patient-caregiver pair will commence immediately after recruitment,
on a rolling basis. 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. Participants from
both groups will be assessed 4 times: at recruitment (T1, baseline); after completing the
intervention, or 5 weeks after recruitment for the control group (T2, post- treatment); three
months after recruitment (T3); six months after recruitment (T4).

The primary outcome measure will be QOL (assessed with the ALS-Specific Quality of
Life-Revised instrument, the ALSSQOL-R) in ALS subjects. Secondary outcomes from ALS subjects
will be: depression and anxiety (assessed with the Hospital Anxiety and Depression Scale),
attained mindfulness level (assessed with the Langer Mindfulness Scale) functional, cognitive
and respiratory variables, assessed respectively with the Self-Administered ALS Functional
Rating Scale-Revised, the Edinburgh Cognitive Assessment and Forced Vital Capacity.
Caregivers outcomes, considered as secondary outcomes, will be QOL (assessed with the Short
Form-36), depression and anxiety (assessed with the Hospital Anxiety and Depression Scale),
care burden (assessed with the Zarit Burden Inventory) and mindfulness (assessed with the
Langer Mindfulness Scale). A sub-sample of the subjects from the intervention group may be
invited to a semi-structured interview about the experience with the treatment.

After the last assessment, subjects in the control group will have the option to enter the
mindfulness program. All the subjects will have the option to continue to use the program
after the 5-week intervention.

Inclusion Criteria:

Inclusion Criteria for ALS Subjects:

- 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.

Inclusion Criteria for Caregivers:

- Must have the physical ability to use a computer and access the Internet.

Exclusion Criteria:

Exclusion Criteria for ALS Subjects:

- 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.

Exclusion Criteria for Caregivers:

- 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.