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Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)

Building Community Capacity for Disability Prevention for Minority Elders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02317432
Enrollment
307
Registered
2014-12-16
Start date
2015-07-31
Completion date
2019-03-01
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Physical Disability

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

BEHAVIORALComparison of a combined CBT + exercise intervention and enhanced usual care

Sponsors

New York University
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up6-months post-baselineThe 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 Sessions6-months post-baselineThe 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-up6-months post-baselineThe 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-baselineThe 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-baselineThe 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-up6-moths post-baselineThe 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

ArmCount
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
Total307

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath41
Overall StudyDid not complete any CBT/InVEST sessions or the recommended number of sessions270
Overall StudyLost to Follow-up05

Baseline characteristics

CharacteristicCBT + InVEST ExerciseEnhanced Usual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
144 Participants142 Participants286 Participants
Age, Categorical
Between 18 and 65 years
9 Participants12 Participants21 Participants
Age, Continuous74.86 years75.44 years75.15 years
Ethnicity (NIH/OMB)
Hispanic or Latino
64 Participants72 Participants136 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
64 Participants55 Participants119 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
25 Participants27 Participants52 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 Participants6 Participants8 Participants
Race (NIH/OMB)
Asian
51 Participants51 Participants102 Participants
Race (NIH/OMB)
Black or African American
15 Participants14 Participants29 Participants
Race (NIH/OMB)
More than one race
26 Participants30 Participants56 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
NA ParticipantsNA ParticipantsNA Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants6 Participants15 Participants
Race (NIH/OMB)
White
50 Participants47 Participants97 Participants
Region of Enrollment
United States
153 participants154 participants307 participants
Sex: Female, Male
Female
123 Participants125 Participants248 Participants
Sex: Female, Male
Male
30 Participants29 Participants59 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 1531 / 154
other
Total, other adverse events
0 / 1530 / 154
serious
Total, serious adverse events
0 / 1530 / 154

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
CBT + InVEST ExerciseChange in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up4.80 units on a scaleStandard Error 0.38
Enhanced Usual CareChange in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up5.29 units on a scaleStandard Error 0.39
p-value: 0.35Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
CBT + InVEST ExerciseChange in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up7.89 units on a scaleStandard Error 0.22
Enhanced Usual CareChange in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up7.29 units on a scaleStandard Error 0.19
p-value: 0.03Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
CBT + InVEST ExerciseChange 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 scaleStandard Error 0.66
Enhanced Usual CareChange 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 scaleStandard Error 0.69
p-value: 0.15Mixed Models Analysis
Primary

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.

ArmMeasureValue (MEAN)Dispersion
CBT + InVEST ExerciseChange in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up1.44 units on a scaleStandard Error 0.03
Enhanced Usual CareChange in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up1.56 units on a scaleStandard Error 0.038
p-value: <0.01Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
CBT + InVEST ExerciseChange 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 scaleStandard Error 2.34
Enhanced Usual CareChange 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 scaleStandard Error 2.16
p-value: 0.02Mixed Models Analysis
Primary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
CBT + InVEST ExerciseNumber of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention SessionsSatisfaction (very satisfied)121 Participants
CBT + InVEST ExerciseNumber of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention SessionsCBT118 Participants
CBT + InVEST ExerciseNumber of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention SessionsInVEST63 Participants
CBT + InVEST ExerciseNumber of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention SessionsCBT and InVEST58 Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026