Trial Outcomes & Findings for Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure (NCT NCT03431493)
NCT ID: NCT03431493
Last Updated: 2025-09-22
Results Overview
Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
End of intervention (12 weeks)
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
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.
|
Usual Care Control
Usual Care Control
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
28
|
|
Overall Study
COMPLETED
|
21
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
Baseline characteristics by cohort
| Measure |
Behavioral Activation - Rehabilitation
n=24 Participants
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.
|
Usual Care Control
n=28 Participants
Usual Care Control
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants in the intervention group only
Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=24 Participants
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.
|
Usual Care Control
Usual Care Control
|
|---|---|---|
|
Feasibility Measure Per Participant
|
0.8 proportion of intended visits
|
—
|
PRIMARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants in the intervention group only
Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=224 visits
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.
|
Usual Care Control
Usual Care Control
|
|---|---|---|
|
Total Feasibility Measure
|
0.94 proportion of total intervention visits
|
—
|
PRIMARY outcome
Timeframe: End of intervention (12 weeks)Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=24 Participants
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.
|
Usual Care Control
n=28 Participants
Usual Care Control
|
|---|---|---|
|
Feasibility Measure/Assess Loss to Follow-up
|
0.88 proportion of participants
|
0.93 proportion of participants
|
PRIMARY outcome
Timeframe: End of intervention (12 weeks)Average number of patients enrolled per month over 12 weeks
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=24 Participants
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.
|
Usual Care Control
n=28 Participants
Usual Care Control
|
|---|---|---|
|
Feasibility Measure
|
0.3 average participants per month
Standard Deviation 0.5
|
0.4 average participants per month
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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).
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=21 Participants
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.
|
Usual Care Control
n=26 Participants
Usual Care Control
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
|
6.6 score on a scale
Standard Deviation 3.6
|
6.5 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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).
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=21 Participants
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.
|
Usual Care Control
n=26 Participants
Usual Care Control
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
|
6.9 score on a scale
Standard Deviation 4.9
|
5.0 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=25 Participants
Usual Care Control
|
|---|---|---|
|
Personal Health Questionnaire - 8 Item Version (PHQ-8)
|
9.3 score on a scale
Standard Deviation 6.9
|
6.0 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=21 Participants
Usual Care Control
|
|---|---|---|
|
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT) - Basic Mobility Score
|
62.4 score on a scale
Standard Deviation 8.5
|
61.4 score on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=21 Participants
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.
|
Usual Care Control
n=26 Participants
Usual Care Control
|
|---|---|---|
|
EQ-5D-5L - Utility Score
|
0.66 score on a scale
Standard Deviation 0.31
|
0.80 score on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Patients with data collected
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of patients with inpatient readmissions
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Healthcare Utilization - Readmissions
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: end of intervention (12 weeks)Population: patients with data collected
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of participants who ever utilized outpatient mental health
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=18 Participants
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.
|
Usual Care Control
n=22 Participants
Usual Care Control
|
|---|---|---|
|
Healthcare Utilization - Ever Utilized Mental Health Care
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: end of intervention (12 weeks)Population: patients with data collected
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of patients who ever utilized physical rehabilitation services
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Healthcare Utilization - Rehabilitation
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=18 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Behavioral Activation for Depression SCALE (BAS)
|
95.3 score on a scale
Standard Deviation 34.4
|
104.0 score on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=18 Participants
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.
|
Usual Care Control
n=25 Participants
Usual Care Control
|
|---|---|---|
|
Connor-Davidson Resilience Scale (CD RISC)
|
72.3 score on a scale
Standard Deviation 17.0
|
78.5 score on a scale
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: 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).
Measure of adherence
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: This outcome is for intervention group only
Measure of adherence for intervention group
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=24 Participants
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.
|
Usual Care Control
Usual Care Control
|
|---|---|---|
|
Percentage of Sessions Fully Completed and Partially Completed
|
0.94 percentage of sessions completed
|
—
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
Measure of cognitive impairment. Score range 0 - 22. Higher scores indicate better cognitive function.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=20 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) - BLIND
|
18.6 score on a scale
Standard Deviation 3.4
|
17.8 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=21 Participants
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.
|
Usual Care Control
n=26 Participants
Usual Care Control
|
|---|---|---|
|
Impact of Events Scale - Revised (IES-R)
|
0.97 score on a scale
Standard Deviation 0.69
|
0.85 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Self Distraction Subscale
|
4.8 score on a scale
Standard Deviation 2.4
|
4.2 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Active Coping Subscale
|
5.7 score on a scale
Standard Deviation 1.9
|
5.8 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: end of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Denial Subscale
|
3.4 score on a scale
Standard Deviation 1.6
|
3.3 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Substance Use Subscale
|
2.1 score on a scale
Standard Deviation 0.46
|
2.1 score on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Emotional Support Subscale
|
5.7 score on a scale
Standard Deviation 2.2
|
6.0 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Instrumental Support Subscale
|
4.6 score on a scale
Standard Deviation 2.2
|
5.4 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Behavioral Disengagement Subscale
|
3.1 score on a scale
Standard Deviation 2.0
|
2.4 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Venting Subscale
|
4.2 score on a scale
Standard Deviation 1.5
|
3.5 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Positive Reframing Subscale
|
5.2 score on a scale
Standard Deviation 1.8
|
5.1 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Planning Subscale
|
5.6 score on a scale
Standard Deviation 1.7
|
5.6 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Humor Subscale
|
3.5 score on a scale
Standard Deviation 1.7
|
4.0 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Acceptance Subscale
|
6.6 score on a scale
Standard Deviation 1.9
|
6.7 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Religion Subscale
|
5.3 score on a scale
Standard Deviation 2.5
|
5.5 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: End of intervention (12 weeks)Population: Participants with data collected
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.
Outcome measures
| Measure |
Behavioral Activation - Rehabilitation
n=19 Participants
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.
|
Usual Care Control
n=24 Participants
Usual Care Control
|
|---|---|---|
|
Brief Coping With Problems Experienced (Brief COPE) - Self-Blame Subscale
|
3.8 score on a scale
Standard Deviation 2.0
|
3.5 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 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.
A clinical interview to assess depressive symptoms. This is a qualitative assessment.
Outcome measures
Outcome data not reported
Adverse Events
Behavioral Activation - Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place