Anxiety, Depression, Physical Disability
Conditions
Keywords
Depression, Anxiety, Disability, Ethnic Minority, Elders
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 60+ * Fluency in English, Spanish, Mandarin or Cantonese * Score above threshold on PHQ-9, GAD-7, or Geriatric Depression Scale (GDS-Short Form) * Score within threshold of SPPB
Exclusion criteria
* Participants will be excluded if there is evidence of: * Current substance use disorders * Current or last 3 months of specialty mental health treatment * Evidence that patient the participant lacks capacity to consent assessed using the UCSD Brief Assessment of Capacity to Consent. * Suicidal risk (score of 4 or 5 on the Paykel suicide questionnaire), whereby participant will be referred for immediate treatment to specialty care * If the participant's physician advises against strenuous physical exercise. * Exclusion from the disability component will also happen if the participant is home-bound, has an acute or an exacerbated chronic disease, or has neuro-musculoskeletal impairment that prevents them from participating in the exercises
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | 6-months post-baseline | 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. |
| Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions | 6-months post-baseline | 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. |
| Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | 6-months post-baseline | 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. |
| 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. | 6-months post-baseline | 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. |
| 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. | 6-months post-baseline | 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. |
| Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | 6-moths post-baseline | 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. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT + InVEST Exercise 10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. | 153 |
| 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. | 154 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 1 |
| Overall Study | Did not complete any CBT/InVEST sessions or the recommended number of sessions | 27 | 0 |
| Overall Study | Lost to Follow-up | 0 | 5 |
Baseline characteristics
| Characteristic | CBT + InVEST Exercise | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 144 Participants | 142 Participants | 286 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Continuous | 74.86 years | 75.44 years | 75.15 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 64 Participants | 72 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 55 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 27 Participants | 52 Participants |
| Function Component of the Late Life Functioning and Disability Instrument (LLFDI) | 118.42 units on a scale STANDARD_DEVIATION 25.96 | 116.75 units on a scale STANDARD_DEVIATION 26.2 | 117.58 units on a scale STANDARD_DEVIATION 26.05 |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | 6.18 units on a scale STANDARD_DEVIATION 4.63 | 5.79 units on a scale STANDARD_DEVIATION 4.56 | 5.99 units on a scale STANDARD_DEVIATION 4.59 |
| Hopkins Symptom Checklist-25 (HSCL-25) | 1.62 units on a scale STANDARD_DEVIATION 0.42 | 1.63 units on a scale STANDARD_DEVIATION 0.46 | 1.62 units on a scale STANDARD_DEVIATION 0.44 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 51 Participants | 51 Participants | 102 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 26 Participants | 30 Participants | 56 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) White | 50 Participants | 47 Participants | 97 Participants |
| Region of Enrollment United States | 153 participants | 154 participants | 307 participants |
| Sex: Female, Male Female | 123 Participants | 125 Participants | 248 Participants |
| Sex: Female, Male Male | 30 Participants | 29 Participants | 59 Participants |
| Short Physical Performance Battery (SPPB) | 7.58 units on a scale STANDARD_DEVIATION 2.3 | 7.38 units on a scale STANDARD_DEVIATION 2.03 | 7.48 units on a scale STANDARD_DEVIATION 2.17 |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 21.97 units on a scale STANDARD_DEVIATION 7.09 | 22.40 units on a scale STANDARD_DEVIATION 7.86 | 22.19 units on a scale STANDARD_DEVIATION 7.48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 153 | 1 / 154 |
| other Total, other adverse events | 0 / 153 | 0 / 154 |
| serious Total, serious adverse events | 0 / 153 | 0 / 154 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT + InVEST Exercise | Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | 4.80 units on a scale | Standard Error 0.38 |
| Enhanced Usual Care | Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | 5.29 units on a scale | Standard Error 0.39 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT + InVEST Exercise | Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | 7.89 units on a scale | Standard Error 0.22 |
| Enhanced Usual Care | Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | 7.29 units on a scale | Standard Error 0.19 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT + InVEST Exercise | 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 units on a scale | Standard Error 0.66 |
| 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. | 22.47 units on a scale | Standard Error 0.69 |
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
Population: Intent to treat population (all participants assigned to CBT + InVEST exercise or Enhanced Usual Care). Multiple imputation by chained equations (MICE) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT + InVEST Exercise | Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | 1.44 units on a scale | Standard Error 0.03 |
| Enhanced Usual Care | Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | 1.56 units on a scale | Standard Error 0.038 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT + InVEST Exercise | 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 units on a scale | Standard Error 2.34 |
| 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. | 114.87 units on a scale | Standard Error 2.16 |
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
Population: Analysis population includes only participants in the CBT + InVEST exercise group because the outcome (number of participants attending more than 50% of the intervention sessions and reporting satisfaction with the intervention sessions) cannot be measured for participants in the Enhanced Usual Care group since they did not receive the intervention sessions.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CBT + InVEST Exercise | Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions | Satisfaction (very satisfied) | 121 Participants |
| CBT + InVEST Exercise | Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions | CBT | 118 Participants |
| CBT + InVEST Exercise | Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions | InVEST | 63 Participants |
| CBT + InVEST Exercise | Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions | CBT and InVEST | 58 Participants |