An interventional study of Comparison of a combined CBT + exercise intervention and enhanced usual care in Depression, Anxiety and Physical Disability, sponsored by Massachusetts General Hospital. Completed at 8 sites in 2 countries. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
The primary intervention offered through this study is a manualized and culturally adapted CBT intervention combined with an exercise intervention, administered by trained Community Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. In addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. Thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.
The researchers have partnered with 5 community-based organizations and 2 clinics, each of whom will recruit 60 elder participants to be randomized into either the intervention (CBT+exercise) or control (enhanced usual care) groups. Each participant randomized into the intervention group will receive 10 sessions of individual CBT for depression and anxiety (Positive Minds), using a translated and culturally adapted manual, and administered by a trained community health worker. In addition, each participant will engage in three exercise groups per week for 12 weeks, using the Increased Velocity Specific to Task (Strong Bodies; InVEST) protocol. Both intervention and control groups will be assessed biweekly for symptoms of depression, anxiety, and suicidality, and both groups will participate in a thorough assessment at baseline, and 2, 6, and 12 months after baseline.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 307 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care
Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions
The number of participants attending more than 50% of intervention sessions was measured in three ways: (1) number attending 50% or more of the CBT sessions (CBT), (2) number attending 50% or more of the InVEST exercise sessions (InVEST), and (3) number attending 50% or more of the CBT and InVEST sessions (CBT and InVEST). Satisfaction with the intervention sessions was measured as the number of participants reporting to be "very satisfied".
Time frame: 6-months post-baseline
Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up
The HSCL-25 is a 25-item screener of mood symptoms (ten anxiety symptoms and 15 depressive symptoms). Respondents are asked how much they were bothered by each symptom in the last four weeks, with responses rated on a 4-point scale (1 = not at all and 4 = extremely). Total scores are computed averaging all items (range: 1-4), and higher scores represent worse symptoms.
Time frame: 6-months post-baseline
Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up
The SPPB is an objective assessment tool developed by the National Institute of Aging to evaluate lower extremity functioning in older persons. It includes three tests (subscales) of functional relevance: standing balance, 4-meter gait speed, and five-repetition sit-to-stand motion. Each of the three components is scored on a 5-point subscale from 0 (unable to perform or low performance) to 4 (high performance). These three subscales are added to obtain a summary score than ranges between 0 and 12, with higher scores representing higher performance of physical functioning.
Time frame: 6-months post-baseline
Change in Self-reported Level of Functioning in the Function Component of the Late Life Functioning and Disability Instrument (LLFDI) From Baseline, at 6-month Follow-up.
The Function Component of the LLFDI is a 32-item self-reported measure assessing difficulty in performing discrete daily physical activities in older adults. Respondents are asked about difficulties performing an activity without help from someone else or the use of assisted devices, with responses rated on a 5-point scale (1 = cannot do and 5 = none). Total scores are calculated summing all items (range: 32-160), and lower scores (approaching 32) are worse as they indicate more difficulties performing discrete daily activities, while higher scores are better as they indicate less difficulties.
Time frame: 6-months post-baseline
Change in Level of Functioning in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) From Baseline, at 6-month Follow-up.
The WHODAS 2.0 is a 12-item measure of level of functioning in six domains of life: Cognition, mobility, self-care, getting along, life activities, and participation. Respondents are asked about functioning difficulties experienced in the last 30 days, with responses rated on a 5-point scale (1 = none and 5 = extreme or cannot do). Final scores are calculated summing all items (range: 12-60), and higher scores represent more difficulties.
Time frame: 6-months post-baseline
Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up
The GAD-7 is a 7-item self-reported tool to identify probable cases of Generalized Anxiety Disorder. Respondents are asked how often, during the last two weeks, they were bothered by each symptom, with responses rated on a 4-point scale (0 = not at all and 3 = nearly every day). Total scores are calculated summing all items (range: 0-21), and higher scores represent worse symptoms.
Time frame: 6-moths post-baseline
| Milestone | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| Started | 153 | 154 |
| Completed cbt | 118 | 0 |
| Completed invest | 63 | 0 |
| Completed cbt + invest exercise | 122 | 0 |
| Completed enhanced usual care | 0 | 148 |
| Completed | 122 | 148 |
| Not completed | 31 | 6 |
| Withdrew: Death | 4 | 1 |
| Withdrew: Lost to follow-up | 0 | 5 |
| Withdrew: Did not complete any cbt/invest sessions or the recommended number of sessions | 27 | 0 |
The number of participants attending more than 50% of intervention sessions was measured in three ways: (1) number attending 50% or more of the CBT sessions (CBT), (2) number attending 50% or more of the InVEST exercise sessions (InVEST), and (3) number attending 50% or more of the CBT and InVEST sessions (CBT and InVEST). Satisfaction with the intervention sessions was measured as the number of participants reporting to be "very satisfied".
| Participants | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| CBT | 118 | — |
| InVEST | 63 | — |
| CBT and InVEST | 58 | — |
| Satisfaction (very satisfied) | 121 | — |
The HSCL-25 is a 25-item screener of mood symptoms (ten anxiety symptoms and 15 depressive symptoms). Respondents are asked how much they were bothered by each symptom in the last four weeks, with responses rated on a 4-point scale (1 = not at all and 4 = extremely). Total scores are computed averaging all items (range: 1-4), and higher scores represent worse symptoms.
| units on a scale | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | 1.44 ± .030 | 1.56 ± .038 |
The SPPB is an objective assessment tool developed by the National Institute of Aging to evaluate lower extremity functioning in older persons. It includes three tests (subscales) of functional relevance: standing balance, 4-meter gait speed, and five-repetition sit-to-stand motion. Each of the three components is scored on a 5-point subscale from 0 (unable to perform or low performance) to 4 (high performance). These three subscales are added to obtain a summary score than ranges between 0 and 12, with higher scores representing higher performance of physical functioning.
| units on a scale | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | 7.89 ± 0.22 | 7.29 ± 0.19 |
The Function Component of the LLFDI is a 32-item self-reported measure assessing difficulty in performing discrete daily physical activities in older adults. Respondents are asked about difficulties performing an activity without help from someone else or the use of assisted devices, with responses rated on a 5-point scale (1 = cannot do and 5 = none). Total scores are calculated summing all items (range: 32-160), and lower scores (approaching 32) are worse as they indicate more difficulties performing discrete daily activities, while higher scores are better as they indicate less difficulties.
| units on a scale | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| Change in Self-reported Level of Functioning in the Function Component of the Late Life Functioning and Disability Instrument (LLFDI) From Baseline, at 6-month Follow-up. | 120.87 ± 2.34 | 114.87 ± 2.16 |
The WHODAS 2.0 is a 12-item measure of level of functioning in six domains of life: Cognition, mobility, self-care, getting along, life activities, and participation. Respondents are asked about functioning difficulties experienced in the last 30 days, with responses rated on a 5-point scale (1 = none and 5 = extreme or cannot do). Final scores are calculated summing all items (range: 12-60), and higher scores represent more difficulties.
| units on a scale | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| Change in Level of Functioning in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) From Baseline, at 6-month Follow-up. | 21.23 ± 0.66 | 22.47 ± 0.69 |
The GAD-7 is a 7-item self-reported tool to identify probable cases of Generalized Anxiety Disorder. Respondents are asked how often, during the last two weeks, they were bothered by each symptom, with responses rated on a 4-point scale (0 = not at all and 3 = nearly every day). Total scores are calculated summing all items (range: 0-21), and higher scores represent worse symptoms.
| units on a scale | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
| Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | 4.80 ± 0.38 | 5.29 ± 0.39 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBT + InVEST Exercise | 4/153 (2.6%) | 0/153 (0%) | 0/153 (0%) |
| Enhanced Usual Care | 1/154 (0.6%) | 0/154 (0%) | 0/154 (0%) |
| Age, Categorical(Participants) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 12 | 21 |
| >=65 years | 144 | 142 | 286 |
| Age, Continuous(years) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 74.86 (62 to 94) | 75.44 (62 to 95) | 75.15 (62 to 95) |
| Sex: Female, Male(Participants) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Female | 123 | 125 | 248 |
| Male | 30 | 29 | 59 |
| Ethnicity (NIH/OMB)(Participants) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 64 | 72 | 136 |
| Not Hispanic or Latino | 64 | 55 | 119 |
| Unknown or Not Reported | 25 | 27 | 52 |
| Race (NIH/OMB)(Participants) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 6 | 8 |
| Asian | 51 | 51 | 102 |
| Native Hawaiian or Other Pacific Islander | NA | NA | NA |
| Black or African American | 15 | 14 | 29 |
| White | 50 | 47 | 97 |
| More than one race | 26 | 30 | 56 |
| Unknown or Not Reported | 9 | 6 | 15 |
| Region of Enrollment(participants) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| United States | 153 | 154 | 307 |
| Hopkins Symptom Checklist-25 (HSCL-25)(units on a scale) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 1.62 ± .42 | 1.63 ± .46 | 1.62 ± .44 |
| Short Physical Performance Battery (SPPB)(units on a scale) | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Mean | 7.58 ± 2.30 | 7.38 ± 2.03 | 7.48 ± 2.17 |
3 further baseline measures are reported on the registry.
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Massachusetts General Hospital