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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant's exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding "valued activities"; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week's goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant's progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12.
Johns Hopkins University
Baltimore, Maryland, United States
Feasibility Measure Per Participant
Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.
Time frame: End of intervention (12 weeks)
Total Feasibility Measure
Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study
Time frame: End of intervention (12 weeks)
Feasibility Measure/Assess Loss to Follow-up
Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.
Time frame: End of intervention (12 weeks)
Feasibility Measure
Average number of patients enrolled per month over 12 weeks
Time frame: End of intervention (12 weeks)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
An instrument used to assess anxiety symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).
Time frame: End of intervention (12 weeks)
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
An instrument used to assess depressive symptoms. Scores range from 0 to 21. A HADS score ≥8 indicates clinically important symptoms on either subscale (more symptoms).
Time frame: End of intervention (12 weeks)
Personal Health Questionnaire - 8 Item Version (PHQ-8)
The PHQ-8 uses a 4-point Likert scale to assess depressive symptoms. The score range is 0 to 27. Scores 5-9 indicate "mild" symptoms, 10-14 "moderate", and ≥20 "severe" depressive symptoms. Higher score more symptoms.
Time frame: End of intervention (12 weeks)
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score
The AMPAC-CAT, a measure of physical function, has 269 items across three domains (basic mobility, daily activity and applied cognitive). The computer adaptive test requires a mean of 22 items from the item bank. Scores are norm-based (min 0 and mx 100). Higher scores indicate better function.
Time frame: End of intervention (12 weeks)
EQ-5D-5L - Utility Score
The EQ-5D-5L is an instrument developed by the EuroQol group to measure health status. The Eq-5D-5L has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, ranging from 1 (no problems) to 5 (extreme problems). The resulting health utility score ranges from -0.11 to 1.00. Higher scores indicate better health status.
Time frame: End of intervention (12 weeks)
Healthcare Utilization - Readmissions
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of patients with inpatient readmissions
Time frame: End of intervention (12 weeks)
Healthcare Utilization - Ever Utilized Mental Health Care
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of participants who ever utilized outpatient mental health
Time frame: end of intervention (12 weeks)
Healthcare Utilization - Rehabilitation
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of patients who ever utilized physical rehabilitation services
Time frame: end of intervention (12 weeks)
Behavioral Activation for Depression SCALE (BAS)
This is a 25-item scale that measures changes in avoidance and activation over the course of Behavioral Activation treatment using a 7 point scale (0=not at all to 6=completely). The scale is grouped into 4 subscales (Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment). To calculate a total score, items on all subscales other than Activation are reverse-coded and then an unweighted sum is computed. Score range 0 to 150. Higher scores indicate greater activation.
Time frame: End of intervention (12 weeks)
Connor-Davidson Resilience Scale (CD RISC)
This is a 25-item scale with each item rated on a 5-point scale (higher scores indicating greater resilience). The total score ranges from 0 to 100.
Time frame: End of intervention (12 weeks)
Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session
Measure of adherence
Time frame: End of intervention (12 weeks)
Percentage of Sessions Fully Completed and Partially Completed
Measure of adherence for intervention group
Time frame: End of intervention (12 weeks)
Montreal Cognitive Assessment (MoCA) - BLIND
Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.
Time frame: End of intervention (12 weeks)
Impact of Events Scale - Revised (IES-R)
This is a measure the subjective response to a specific traumatic event (in this case - critical illness and associated ICU experience). The IES-R consists of 22 items, each rated on a 5-point scale; item scores are averaged to generate a mean total score (range: 0-4). Higher score indicates more stress symptoms.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: end of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale
A 28-item measure of coping strategies with responses provided using a 4-point Likert scale. Minimum score=2 to Maximum score=8. Higher score indicates greater use of the specified coping strategy.
Time frame: End of intervention (12 weeks)
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
A clinical interview to assess depressive symptoms. This is a qualitative assessment.
Time frame: End of intervention (12 weeks)
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