Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Cardiology, Hospital, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/22/2018 |
| Start Date: | March 2, 2018 |
| End Date: | June 2021 |
| Contact: | Albahi M Malik |
| Email: | amalik37@jhmi.edu |
| Phone: | 4109558706 |
A Pilot, Feasibility Randomized Controlled Trial of a Behavioral Activation And Rehabilitation Intervention To Improve Psychological And Physical Impairments In Acute Respiratory Failure Survivors
More and more people are surviving after receiving life support for respiratory failure in
the intensive care unit, but these patients often experience problems with depression and
physical functioning that lead to reduced quality of life. There is a lack of treatment for
these patients, with past research suggesting that treatment may be more successful if mental
and physical health are addressed at the same time. This research evaluates whether a therapy
delivered via telephone and home visits, combining treatment for depression and physical
rehabilitation, is feasible and might help patients recover.
the intensive care unit, but these patients often experience problems with depression and
physical functioning that lead to reduced quality of life. There is a lack of treatment for
these patients, with past research suggesting that treatment may be more successful if mental
and physical health are addressed at the same time. This research evaluates whether a therapy
delivered via telephone and home visits, combining treatment for depression and physical
rehabilitation, is feasible and might help patients recover.
A growing number of Acute Respiratory Failure (ARF) survivors are burdened by depressive
symptoms and physical impairments that last for years after intensive care unit discharge.
Notably, depressive symptoms are independently associated with subsequent development of new
impairments in physical functioning. There is a lack of treatment options to address these
impairments in ARF survivors, with past research suggesting combining treatment for mental
and physical health might be more successful.
Therefore, this study is designed to evaluate:
1. The feasibility (primary outcome) of participant recruitment and retention in a pilot
randomized controlled trial (RCT) of an intervention combining Behavioral Activation (an
evidence-based psychological treatment for depression) and physical rehabilitation
delivered via telephone and 2 home visits over 12-weeks versus a "usual care" control
group.
2. The efficacy (secondary outcome) of this Behavioral Activation-Rehabilitation
intervention to reduce depressive symptoms and improve physical functioning.
3. Modifiable psychosocial risk factors for depressive symptoms in ARF survivors and the
association between the intervention and these modifiable factors.
symptoms and physical impairments that last for years after intensive care unit discharge.
Notably, depressive symptoms are independently associated with subsequent development of new
impairments in physical functioning. There is a lack of treatment options to address these
impairments in ARF survivors, with past research suggesting combining treatment for mental
and physical health might be more successful.
Therefore, this study is designed to evaluate:
1. The feasibility (primary outcome) of participant recruitment and retention in a pilot
randomized controlled trial (RCT) of an intervention combining Behavioral Activation (an
evidence-based psychological treatment for depression) and physical rehabilitation
delivered via telephone and 2 home visits over 12-weeks versus a "usual care" control
group.
2. The efficacy (secondary outcome) of this Behavioral Activation-Rehabilitation
intervention to reduce depressive symptoms and improve physical functioning.
3. Modifiable psychosocial risk factors for depressive symptoms in ARF survivors and the
association between the intervention and these modifiable factors.
Inclusion Criteria:
- ≥18 years old
- Living at home before the current admission (not in a facility)
- Acute respiratory failure managed in the ICU > 24hrs (≥1 of the following):
1. Mechanical ventilation via an endotracheal tube or tracheostomy > 12hrs (and not
ventilator-dependent before admission) OR
2. Non-invasive ventilation (CPAP, BiPAP) > 4 hours in a 24 hour period provided for
acute respiratory failure (not for Obstructive Sleep Apnoea (OSA) or other stable
use) OR
3. High flow nasal cannula with Fraction of Inspired Oxygen (FiO2) ≥ 0.5 for ≥4
hours in a 24hr period
- At least mild depressive symptoms (score ≥2 on PHQ-2 scale)
Exclusion Criteria:
- Pre-existing cognitive impairment (based on review of medical records, or proxy-
administered Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
score >3.3)
- Declines informed consent or not capable of providing informed consent
- Non-English speaking
- Homelessness or living >50 miles away from study site
- Bedbound prior to the current admission
- Expected survival < 6 months according to ICU attending
- ICU Length Of Stay (LOS) > 30 days
- Not discharged home from the hospital
- Complex medical care expected soon after discharge (e.g. multiple planned surgeries,
transplantation evaluation, extensive travel needs for hemodialysis, chemotherapy or
radiation therapy, etc)
- Active substance abuse or psychosis
- Lack of access to telephone or inability to use telephone independently
- Pregnancy
- Suicidality
- Incarcerated
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