Serious Mental Illness(HHL)NCT06940843
A Pilot Randomized Controlled Trial of the Hopeful and Healthy Living Program
A study testing Hopeful and Healthy Living (HHL) in people with Serious Mental Illness and Older Adults, run by Boston University Charles River Campus at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Serious Mental Illness, Older Adults
- What is being tested?
- Hopeful and Healthy Living (HHL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years or older, diagnosis of a serious mental illness, and a member of Center Club or Transitions of Boston
Who cannot join
- Diagnosis of dementia or other progressive neurological disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Bay Cove Center Club
Boston, Massachusetts, 02114
Program Director, 617-788-1000, mgregorio@baycove.org
athanson@bu.edu
- Recruiting
Bay Cove Transitions of Boston
Boston, Massachusetts, 02122
Program Director, 617-788-1024, jdorneus@baycove.org
athanson@bu.edu
About this study
Official title: Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program
The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that:
- Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU).
- Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
- Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
- Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
Read more
In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet.
Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.
- Conditions
- Serious Mental Illness, Older Adults
- Being tested
- Hopeful and Healthy Living (HHL)
- Keywords
- psychosocial interventions, cognitive interventions, social skills interventions, healthy lifestyle interventions, older adults with SMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hopeful and Healthy Living (HHL)Behavioural
The HHL intervention is a 16-week long, manualized group intervention. Classes will be held weekly for 90 minutes. The class covers 15 topics centered on building social connections, developing healthy lifestyle routines around eating, exercise, and sleep. Each class will target one social skill (i.e. starting conversations) and one cognitive self-management strategy (i.e. memory tips), which will be taught and practiced in class. Each class also includes a facilitated exercise component and individually tailored take home application activity.
| Study group | Role | What they receive |
|---|---|---|
| HHL group participants | Experimental | Participants will complete the 16-week manualized HHL intervention. This group intervention will occur weekly for 90 minutes. These participants will also continue with treatment as usual. Receives: Behavioral: Hopeful and Healthy Living (HHL) |
| Treatment as usual | No intervention | Participants assigned to this arm will continue with treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MOCA)
Standardized screening tool used for assessing cognition.
Measured: Baseline, 4-, 8-, 12- month followup
The Cognitive Self-Efficacy Scale
10-item measure that assesses confidence in everyday cognitive tasks.
Measured: Baseline, 4-, 8-, 12- month followup
The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure
Adult will be used to assess and statistically control for mental health symptom severity.
Measured: Baseline, 4-, 8-, 12- month followup
The UCLA Loneliness Scale-3-item instrument
3-item screening tool for loneliness.
Measured: Baseline, 4-, 8-, 12- month followup
The Social Provisions Scale
24-item instrument that will be used to measure various types of social supports.
Measured: Baseline, 4-, 8-, 12- month followup
The Physical Activity Scale for the Elderly (PASE)
Standardized measurement of physical activity related to exercise, work, recreation, and daily living activities.
Measured: Baseline, 4-, 8-, 12- month followup
Starting the Conversation
A brief standardized survey for assessing daily eating habits.
Measured: Baseline, 4-, 8-, 12- month followup
Pittsburg Sleep Quality Index (PSQI)
An 11-item tool that is used to assess sleep quality and routines.
Measured: Baseline, 4-, 8-, 12- month followup
Secondary outcomes (1)
HHL Group Satisfaction and Feedback Survey
For experimental group participants only.
Measured: 4-month assessment only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start12 Mar 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Bay Cove Human Services
- Responsible party
- Sponsor
- Investigators
- Susan McGurk, PhD, Principal investigator, Boston UniversityKim Mueser, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940843
- Sponsor's protocol ID
- 7458B
- Other IDs
- 90RTHF0007
- Acronym
- (HHL)
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program
- ClinicalTrials.gov ID
- NCT06940843
- Acronym / sponsor ID
- (HHL) / 7458B
- Conditions
- Serious Mental Illness, Older Adults
- Keywords
- psychosocial interventions, cognitive interventions, social skills interventions, healthy lifestyle interventions, older adults with SMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Bay Cove Human Services
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that:
- Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU).
- Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
- Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
- Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet.
Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHL group participants | Experimental | Behavioral: Hopeful and Healthy Living (HHL)Participants will complete the 16-week manualized HHL intervention. This group intervention will occur weekly for 90 minutes. These participants will also continue with treatment as usual. |
| Treatment as usual | No intervention | –Participants assigned to this arm will continue with treatment as usual. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50 years or older, diagnosis of a serious mental illness, and a member of Center Club or Transitions of Boston
Key exclusion criteria (1 listed)
- Diagnosis of dementia or other progressive neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hopeful and Healthy Living (HHL)The HHL intervention is a 16-week long, manualized group intervention. Classes will be held weekly for 90 minutes. The class covers 15 topics centered on building social connections, developing healthy lifestyle routines around eating, exercise, and sleep. Each class will target one social skill (i.e. starting conversations) and one cognitive self-management strategy (i.e. memory tips), which will be taught and practiced in class. Each class also includes a facilitated exercise component and individually tailored take home application activity. | Behavioural | HHL group participants |
Primary outcome
Montreal Cognitive Assessment (MOCA)
Time frame: Baseline, 4-, 8-, 12- month followup
Standardized screening tool used for assessing cognition.
The Cognitive Self-Efficacy Scale
Time frame: Baseline, 4-, 8-, 12- month followup
10-item measure that assesses confidence in everyday cognitive tasks.
The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure
Time frame: Baseline, 4-, 8-, 12- month followup
Adult will be used to assess and statistically control for mental health symptom severity.
The UCLA Loneliness Scale-3-item instrument
Time frame: Baseline, 4-, 8-, 12- month followup
3-item screening tool for loneliness.
The Social Provisions Scale
Time frame: Baseline, 4-, 8-, 12- month followup
24-item instrument that will be used to measure various types of social supports.
The Physical Activity Scale for the Elderly (PASE)
Time frame: Baseline, 4-, 8-, 12- month followup
Standardized measurement of physical activity related to exercise, work, recreation, and daily living activities.
Starting the Conversation
Time frame: Baseline, 4-, 8-, 12- month followup
A brief standardized survey for assessing daily eating habits.
Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline, 4-, 8-, 12- month followup
An 11-item tool that is used to assess sleep quality and routines.
1 secondary outcome
HHL Group Satisfaction and Feedback Survey
Time frame: 4-month assessment only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan McGurk, PhD principal investigator
Boston University
Kim Mueser, PhD principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hopeful and Healthy Living (HHL) in people with Serious Mental Illness and Older Adults, run by Boston University Charles River Campus at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexa R Trolley-Hanson, MS OTR/L (16037480379, athanson@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MOCA) (time frame: Baseline, 4-, 8-, 12- month followup). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.