Critical Care, Depression, Rehabilitation, Respiratory Insufficiency
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Activation - Rehabilitation
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Measure Per Participant | End of intervention (12 weeks) | Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete. |
| Total Feasibility Measure | End of intervention (12 weeks) | Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study |
| Feasibility Measure/Assess Loss to Follow-up | End of intervention (12 weeks) | Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled. |
| Feasibility Measure | End of intervention (12 weeks) | Average number of patients enrolled per month over 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L - Utility Score | End of intervention (12 weeks) | 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. |
| Healthcare Utilization - Readmissions | End of intervention (12 weeks) | Patient interview to assess the following end of study (ie \ 12 weeks) variable: number of patients with inpatient readmissions |
| Healthcare Utilization - Ever Utilized Mental Health Care | end of intervention (12 weeks) | Patient interview to assess the following end of study (ie \ 12 weeks) variable: number of participants who ever utilized outpatient mental health |
| Healthcare Utilization - Rehabilitation | end of intervention (12 weeks) | Patient interview to assess the following end of study (ie \ 12 weeks) variable: number of patients who ever utilized physical rehabilitation services |
| Behavioral Activation for Depression SCALE (BAS) | End of intervention (12 weeks) | 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. |
| Connor-Davidson Resilience Scale (CD RISC) | End of intervention (12 weeks) | 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. |
| Number of Phone Attempts Needed by the OT to Reach the Participant for Each Session | End of intervention (12 weeks) | Measure of adherence |
| Percentage of Sessions Fully Completed and Partially Completed | End of intervention (12 weeks) | Measure of adherence for intervention group |
| Montreal Cognitive Assessment (MoCA) - BLIND | End of intervention (12 weeks) | Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function. |
| Impact of Events Scale - Revised (IES-R) | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale | End of intervention (12 weeks) | 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. |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | End of intervention (12 weeks) | 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). |
| Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale | End of intervention (12 weeks) | 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. |
| Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale | End of intervention (12 weeks) | 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. |
| Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5) | End of intervention (12 weeks) | A clinical interview to assess depressive symptoms. This is a qualitative assessment. |
| Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale | end of intervention (12 weeks) | 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. |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | End of intervention (12 weeks) | 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). |
| Personal Health Questionnaire - 8 Item Version (PHQ-8) | End of intervention (12 weeks) | 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. |
| Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score | End of intervention (12 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Activation - Rehabilitation Behavioral Activation - Rehabilitation
Behavioral Activation - Rehabilitation: 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. | 24 |
| Usual Care Control Usual Care Control | 28 |
| Total | 52 |
Baseline characteristics
| Characteristic | Behavioral Activation - Rehabilitation | Usual Care Control | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 14.1 | 56.0 years STANDARD_DEVIATION 12.2 | 57.6 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 27 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 9 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 18 Participants | 32 Participants |
| Region of Enrollment United States | 24 Participants | 28 Participants | 52 Participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 2 / 28 |
| other Total, other adverse events | 0 / 24 | 0 / 28 |
| serious Total, serious adverse events | 0 / 24 | 0 / 28 |
Outcome results
Primary
Feasibility Measure
Average number of patients enrolled per month over 12 weeks
Time frame: End of intervention (12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Feasibility Measure | 0.3 average participants per month | Standard Deviation 0.5 |
| Usual Care Control | Feasibility Measure | 0.4 average participants per month | Standard Deviation 0.5 |
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Feasibility Measure/Assess Loss to Follow-up | 0.88 proportion of participants |
| Usual Care Control | Feasibility Measure/Assess Loss to Follow-up | 0.93 proportion of participants |
Primary
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)
Population: Participants in the intervention group only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Feasibility Measure Per Participant | 0.8 proportion of intended visits |
Primary
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)
Population: Participants in the intervention group only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Total Feasibility Measure | 0.94 proportion of total intervention visits |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score | 62.4 score on a scale | Standard Deviation 8.5 |
| Usual Care Control | Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score | 61.4 score on a scale | Standard Deviation 10.1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Behavioral Activation for Depression SCALE (BAS) | 95.3 score on a scale | Standard Deviation 34.4 |
| Usual Care Control | Behavioral Activation for Depression SCALE (BAS) | 104.0 score on a scale | Standard Deviation 24.8 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale | 6.6 score on a scale | Standard Deviation 1.9 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale | 6.7 score on a scale | Standard Deviation 1.5 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale | 5.7 score on a scale | Standard Deviation 1.9 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale | 5.8 score on a scale | Standard Deviation 2.1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale | 3.1 score on a scale | Standard Deviation 2 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale | 2.4 score on a scale | Standard Deviation 1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale | 3.4 score on a scale | Standard Deviation 1.6 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale | 3.3 score on a scale | Standard Deviation 2 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale | 5.7 score on a scale | Standard Deviation 2.2 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale | 6.0 score on a scale | Standard Deviation 2.1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale | 3.5 score on a scale | Standard Deviation 1.7 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale | 4.0 score on a scale | Standard Deviation 2.3 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale | 4.6 score on a scale | Standard Deviation 2.2 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale | 5.4 score on a scale | Standard Deviation 1.9 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale | 5.6 score on a scale | Standard Deviation 1.7 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale | 5.6 score on a scale | Standard Deviation 2.1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale | 5.2 score on a scale | Standard Deviation 1.8 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale | 5.1 score on a scale | Standard Deviation 2.1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale | 5.3 score on a scale | Standard Deviation 2.5 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale | 5.5 score on a scale | Standard Deviation 2.4 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale | 3.8 score on a scale | Standard Deviation 2 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale | 3.5 score on a scale | Standard Deviation 1.6 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale | 4.8 score on a scale | Standard Deviation 2.4 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale | 4.2 score on a scale | Standard Deviation 1.7 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale | 2.1 score on a scale | Standard Deviation 0.46 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale | 2.1 score on a scale | Standard Deviation 0.45 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale | 4.2 score on a scale | Standard Deviation 1.5 |
| Usual Care Control | Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale | 3.5 score on a scale | Standard Deviation 1.6 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Connor-Davidson Resilience Scale (CD RISC) | 72.3 score on a scale | Standard Deviation 17 |
| Usual Care Control | Connor-Davidson Resilience Scale (CD RISC) | 78.5 score on a scale | Standard Deviation 16.2 |
Secondary
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)
Population: Data not collected due to participant survey burden and COVID-19 pandemic-related changes for both research staff and participants.
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | EQ-5D-5L - Utility Score | 0.66 score on a scale | Standard Deviation 0.31 |
| Usual Care Control | EQ-5D-5L - Utility Score | 0.80 score on a scale | Standard Deviation 0.18 |
Secondary
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)
Population: patients with data collected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Healthcare Utilization - Ever Utilized Mental Health Care | 4 Participants |
| Usual Care Control | Healthcare Utilization - Ever Utilized Mental Health Care | 2 Participants |
Secondary
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)
Population: Patients with data collected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Healthcare Utilization - Readmissions | 5 Participants |
| Usual Care Control | Healthcare Utilization - Readmissions | 2 Participants |
Secondary
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)
Population: patients with data collected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Healthcare Utilization - Rehabilitation | 12 Participants |
| Usual Care Control | Healthcare Utilization - Rehabilitation | 13 Participants |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 6.6 score on a scale | Standard Deviation 3.6 |
| Usual Care Control | Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale | 6.5 score on a scale | Standard Deviation 4.5 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 6.9 score on a scale | Standard Deviation 4.9 |
| Usual Care Control | Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 5.0 score on a scale | Standard Deviation 4.1 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Impact of Events Scale - Revised (IES-R) | 0.97 score on a scale | Standard Deviation 0.69 |
| Usual Care Control | Impact of Events Scale - Revised (IES-R) | 0.85 score on a scale | Standard Deviation 0.79 |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Montreal Cognitive Assessment (MoCA) - BLIND | 18.6 score on a scale | Standard Deviation 3.4 |
| Usual Care Control | Montreal Cognitive Assessment (MoCA) - BLIND | 17.8 score on a scale | Standard Deviation 3.5 |
Secondary
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)
Population: Data not collected due to COVID-19 pandemic-related changes for research staff such that fewer staff were available for research procedures, and needed to decrease burden on staff for data collection to allow for prioritizing key data elements (including primary outcomes).
Secondary
Percentage of Sessions Fully Completed and Partially Completed
Measure of adherence for intervention group
Time frame: End of intervention (12 weeks)
Population: This outcome is for intervention group only
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Behavioral Activation - Rehabilitation | Percentage of Sessions Fully Completed and Partially Completed | 0.94 percentage of sessions completed |
Secondary
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)
Population: Participants with data collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Activation - Rehabilitation | Personal Health Questionnaire - 8 Item Version (PHQ-8) | 9.3 score on a scale | Standard Deviation 6.9 |
| Usual Care Control | Personal Health Questionnaire - 8 Item Version (PHQ-8) | 6.0 score on a scale | Standard Deviation 6.2 |