The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older - study population

English fluency and literacy - measures and intervention are in English

Screens positive for emotional distress on either depression or anxiety subscales (>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)

18 years or older - study population

Disqualifiers

1. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coma Family Program 1

    Behavioral

    This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.

  • Coma Family Program 2

    Behavioral

    This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Coma Family Program 1Experimental treatment 1 intervention
Group B: Coma Family Program 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital anxiety and depression scale

Measures anxiety and depression. Anxiety and depression sub scales each range from 0 (minimum) to 21 (maximum) with higher scores meaning worse outcome.

Time frame
baseline, 6-weeks, and 3-month follow-up

Secondary outcomes

1

Posttraumatic stress disorder checklist-5

measures posttraumatic stress symptoms. Scores range from 0 (minimum) to 80 (maximum) with higher scores indicating worse outcome.

Time frame
baseline, 6-weeks, and 3-month follow-up
2

World Health Organization Quality of Life-Short Form

Measures quality of life across four domains, physical, psychological, social, and environmental. Scores on each sub scale range from 0 (minimum) to 100 (maximum) with higher scores indicating better outcome.

Time frame
baseline, 6-weeks, and 3-month follow-up

Other outcomes

1

Cognitive and Affective Mindfulness Scale

measures dispositional mindfulness. Scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better outcome (greater dispositional mindfulness).

Time frame
baseline, 6-weeks, and 3-month follow-up
2

Applied Mindfulness Process Scale

measures applied mindfulness. Scores range from 0 (minimum) to 60 (maximum) with higher scores indicating better outcome (more frequent application of mindfulness skills in daily life).

Time frame
baseline, 6-weeks, and 3-month follow-up
3

Measure of Current Status-A

measures adaptive coping. Scores range from 0 (minimum) to 4 (maximum) with higher scores indicating better outcome (better use of adaptive coping skills).

Time frame
baseline, 6-weeks, and 3-month follow-up
4

Intolerance of Uncertainty Scale Short Form

Measures intolerance of uncertainty. Scores range from 12 (minimum) to 60 (maximum) with higher scores indicating worse outcome (greater intolerance of uncertainty).

Time frame
baseline, 6-weeks, and 3-month follow-up

Sponsors and contacts

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