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Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure
NA trial testing Behavioral Activation - Rehabilitation in Respiratory Insufficiency in 52 participants. Completed in 18 July 2024.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 2 March 2018 |
| Primary completion | 18 July 2024 |
| Estimated completion | 18 July 2024 |
| Sites | 1 location across United States |
Johns Hopkins University
Adults 18 to 100, any sex, with Respiratory Insufficiency or Depression. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total number of intervention visits completed per patient as a proportion of the number of intervention visits each patient is intended to complete.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 0.8 |
Total number of intervention visits completed by all study participants as a proportion of total intervention visits expected in the study
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 0.94 |
Number of patients completing all study follow-up sessions as a proportion of the number of patients enrolled.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 0.88 | |
| Usual Care Control | 0.93 |
Average number of patients enrolled per month over 12 weeks
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 0.3 | ± 0.5 |
| Usual Care Control | 0.4 | ± 0.5 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 6.6 | ± 3.6 |
| Usual Care Control | 6.5 | ± 4.5 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 6.9 | ± 4.9 |
| Usual Care Control | 5.0 | ± 4.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 9.3 | ± 6.9 |
| Usual Care Control | 6.0 | ± 6.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 62.4 | ± 8.5 |
| Usual Care Control | 61.4 | ± 10.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 0.66 | ± 0.31 |
| Usual Care Control | 0.80 | ± 0.18 |
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of patients with inpatient readmissions
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 5 | |
| Usual Care Control | 2 |
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of participants who ever utilized outpatient mental health
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 4 | |
| Usual Care Control | 2 |
Patient interview to assess the following end of study (ie \~12 weeks) variable: number of patients who ever utilized physical rehabilitation services
| Group | Value | 95% CI |
|---|---|---|
| Behavioral Activation - Rehabilitation | 12 | |
| Usual Care Control | 13 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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