Hopeful and Healthy Living Program for Serious Mental Illness

((HHL) Trial)

Recruiting at 1 trial location

Overseen By Alexa R Trolley-Hanson, Masters of Science

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Dementia, Neurological disorders

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program, Hopeful and Healthy Living (HHL), can help adults over 50 with serious mental illness feel less lonely and live healthier lives. Participants will either join a special 16-week group that teaches social skills and ways to manage thoughts or continue their regular treatment. Researchers seek to find out if those in the program feel more supported, think more clearly, and develop better routines, such as improved sleep and diet. The trial seeks individuals who are at least 50 years old, have a serious mental illness, and are part of Center Club or Transitions of Boston, excluding those with dementia or similar conditions. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, as the trial compares the new intervention with treatment as usual.

What prior data suggests that the Hopeful and Healthy Living intervention is safe for adults over 50 with serious mental illness?

Research has shown that lifestyle and social skills programs are generally safe for people with serious mental illness (SMI). A review of studies found that these programs can improve both mental and physical health for individuals with SMI without causing significant harm. Reports indicated no major negative effects, suggesting that participants tolerate these programs well.

The Hopeful and Healthy Living (HHL) program focuses on building social and thinking skills while promoting healthier lifestyles. This non-invasive approach, which avoids medical procedures or drugs, usually lowers the risk of side effects. The emphasis on social support and lifestyle changes is typically safe and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hopeful and Healthy Living (HHL) program is unique for treating serious mental illness because it emphasizes a holistic approach through a structured 16-week intervention. Unlike standard treatments like medication and psychotherapy, which focus mainly on symptoms, HHL aims to enhance overall well-being by combining group sessions that foster community support with lifestyle changes. Researchers are excited about HHL because it could empower individuals to actively participate in their recovery, potentially leading to better long-term mental health outcomes.

What evidence suggests that the Hopeful and Healthy Living intervention might be effective for serious mental illness?

Research has shown that programs like the Hopeful and Healthy Living (HHL) intervention, which participants in this trial may receive, can benefit people with serious mental illness (SMI). Studies have found that these programs can increase hopefulness and improve quality of life. Programs involving peer support, similar to HHL, have boosted mental well-being and encouraged recovery. The lifestyle changes promoted by HHL can enhance mental and physical health by fostering healthier habits. Overall, this evidence suggests that the HHL intervention could help older adults with SMI improve their social connections, thinking skills, and healthy lifestyle habits. ^{1 6 7 8 9}

Who Is on the Research Team?

Susan McGurk, PhD

Principal Investigator

Boston University

Kim Mueser, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for adults over 50 with serious mental illness (SMI) who are interested in improving their social connections and healthy lifestyle habits. Participants should be willing to undergo interview-based assessments at multiple stages and engage in a 16-week group intervention if assigned to the experimental group.

Inclusion Criteria

I am over 50, have a serious mental illness, and belong to Center Club or Transitions of Boston.

Exclusion Criteria

I have been diagnosed with dementia or another progressive neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an interview-based assessment at baseline

1 week

1 visit (in-person)

Treatment

Participants in the experimental group receive the 16-week HHL intervention, while others continue treatment as usual

16 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for changes in social support, cognition, loneliness, psychosocial functioning, and healthy behaviors at 4-, 8-, and 12-month follow-up assessments

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hopeful and Healthy Living (HHL)

Trial Overview The Hopeful and Healthy Living (HHL) program, which includes social skills training and cognitive self-management strategies, is being tested against regular treatment activities. The study aims to see if HHL can improve social support, reduce loneliness, enhance psychosocial functioning, boost cognitive abilities, and encourage healthier behaviors like better sleep, more activity, and improved diet.

How Is the Trial Designed?

Group I: HHL group participants Experimental Treatment 1 Intervention

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.

Group II: Treatment as usual Active Control 1 Intervention

Participants assigned to this arm will continue with treatment as usual.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Bay Cove Human Services

Collaborator

Trials

3

Recruited

2,500+

Published Research Related to This Trial

The Mind-Body Well-being Initiative is a residential treatment model that integrates mental and physical health care, specifically designed for individuals with severe mental illness (SMI) who often face significant health disparities.

This initiative aims to close the 15-20 year life expectancy gap in SMI patients by addressing both their mental health and chronic physical health conditions through a comprehensive Lifestyle Medicine approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mind-Body Well-being Initiative: a better lifestyle for people with severe mental illness. Lalley, NA., Manger, SH., Jacka, F., et al.[2022]

The Wellness Recovery Action Planning (WRAP) intervention, led by peers, significantly reduced psychiatric symptoms in 519 adults with severe mental illness compared to usual care over an 8-week period.

Participants in the WRAP program also reported increased hopefulness and improved quality of life at both the end of treatment and at a 6-month follow-up, highlighting the effectiveness of peer-led self-management strategies in mental health recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a randomized controlled trial of mental illness self-management using Wellness Recovery Action Planning. Cook, JA., Copeland, ME., Jonikas, JA., et al.[2022]

The HOPES program, which includes one year of intensive skills training and health management, significantly improved social skills and psychosocial functioning in older adults with severe mental illness, as shown in a randomized controlled trial with 183 participants.

Retention in the program was high at 80%, and the improvements were notable across various measures, with moderate effect sizes, indicating that the program is a feasible and effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of social rehabilitation and integrated health care for older people with severe mental illness. Mueser, KT., Pratt, SI., Bartels, SJ., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-mental-disorders-2-2025-ce779

Hopeful and Healthy Living Program for Serious Mental ... Participants in the WRAP program also reported increased hopefulness and improved quality of life at both the end of treatment and at a 6-month follow-up, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11203176/

Effectiveness of Peer Support Programs for Severe Mental ... This study aimed to systematically review and meta-analyze the forms and effectiveness of peer support programs for individuals with severe mental illnesses.

3. researchgate.net researchgate.net/publication/389086858_Effectiveness_Of_A_Recovery_Oriented_Program_On_Hope_Mental-Wellbeing_And_Recovery_Process_Among_Severe_Mental_Ill_Patients

Effectiveness Of A Recovery Oriented Program On Hope ... The current study concludes that the recovery-oriented program is effective in enhancing mental wellbeing, fostering hope, and promoting recovery behaviors.

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2806249

Effectiveness of a Lifestyle Intervention for People With ... The lifestyle intervention was effective in reducing weight in people with severe mental illness and may lead to reduced risk of cardiometabolic disorders.

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.966029/full

Lifestyle interventions for people with a severe mental ... We performed a systematic review and meta-analysis to assess the effect of lifestyle interventions on mental and physical health in people with SMI in SHF.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9650385/

Lifestyle interventions for people with a severe mental ... We performed a systematic review and meta-analysis to assess the effect of lifestyle interventions on mental and physical health in people with SMI in SHF.

7. samhsa.gov samhsa.gov/mental-health/serious-mental-illness/about

Serious Mental Illness and Serious Emotional Disturbances SAMHSA is committed to promoting the prevention, treatment, and recovery of mental disorders and to bringing hope to adults who have serious mental illness ( ...

8. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/08008ffd62b4825c86c1ff98ebd385c9/aot-grant-program-smi-implementation-report.pdf

Evaluation of the Assisted Outpatient Treatment Grant ... When utilized, these services are effective in improving clinical, quality of life, social, and public safety outcomes among individuals with mental illness.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1469029225000251

Experiences of exercise services for individuals with ... People living with a severe mental illness experience detrimental outcomes—most notably, a 15- to 20-year reduction of life expectancy relative to the general ...