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

Trial Summary

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 data supports the effectiveness of the Hopeful and Healthy Living treatment for serious mental illness?

Research shows that interventions focusing on self-management, peer support, and fostering hope can improve mental health outcomes. For example, the Wellness Recovery Action Planning (WRAP) program, which includes similar elements, has been shown to reduce psychiatric symptoms and increase hopefulness in people with severe mental illness. ^{1 2 3 4 5}

Is the Hopeful and Healthy Living Program safe for people with serious mental illness?

Research on similar lifestyle programs for people with serious mental illness suggests they are generally safe and can lead to health improvements, such as better diet, sleep, and reduced medication use. These programs focus on lifestyle changes like nutrition and exercise, which are typically safe and beneficial for overall health. ^{6 7 8 9 10}

How is the Hopeful and Healthy Living treatment different from other treatments for serious mental illness?

The Hopeful and Healthy Living (HHL) treatment is unique because it focuses on a holistic approach, integrating lifestyle medicine to address both mind and body well-being, which is not commonly emphasized in traditional treatments for serious mental illness. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Susan McGurk, PhD

Principal Investigator

Boston University

Kim Mueser, PhD

Principal Investigator

Boston University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Determinants, self-management strategies and interventions for hope in people with mental disorders: systematic search and narrative review. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Hopefulness among individuals living with schizophrenia and their caregivers in Tanzania: an actor-partner interdependence model. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Validation of the Integrative Hope Scale in people with psychosis. [2019]

4. Sweden pubmed.ncbi.nlm.nih.gov

Hope as a determinant of mental health recovery: a psychometric evaluation of the Herth Hope Index-Dutch version. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Results of a randomized controlled trial of mental illness self-management using Wellness Recovery Action Planning. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A nutrition intervention is effective in improving dietary components linked to cardiometabolic risk in youth with first-episode psychosis. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Individual physical activity, neighbourhood active living environment and mental illness hospitalisation among adults with cardiometabolic disease: a Canadian population-based cohort analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Less Medication Use in Inpatients With Severe Mental Illness Receiving a Multidisciplinary Lifestyle Enhancing Treatment. The MULTI Study III. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Improved Sleep, Diet, and Exercise in Adults with Serious Mental Illness: Results from a Pilot Self-Management Intervention. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The effectiveness of the Keeping the Body in Mind Xtend pilot lifestyle program on dietary intake in first-episode psychosis: Two-year outcomes. [2020]

11. England pubmed.ncbi.nlm.nih.gov

The Mind-Body Well-being Initiative: a better lifestyle for people with severe mental illness. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of social rehabilitation and integrated health care for older people with severe mental illness. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes of a randomized trial of integrated skills training and preventive healthcare for older adults with serious mental illness. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Enhanced skills training and health care management for older persons with severe mental illness. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Housing and home-leaving experiences of young adults with psychotic disorders: a comparative qualitative study. [2022]