Healthy ReStart Program for Mental Illness

Overseen By Judith A Cook, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cognitive impairment, Non-English speakers

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the COVID-19 pandemic.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Healthy ReStart treatment for mental illness?

The Early Onset Treatment Program (EOTP) for serious mental illness, which shares a focus on coordinated care and recovery-oriented outcomes, showed significant reductions in rehospitalization rates and improvements in symptoms and disability. This suggests that similar recovery-oriented programs like Healthy ReStart may also be effective in improving mental health outcomes. ^{1 2 3 4 5}

Is the Healthy ReStart Program safe for humans?

The available research on similar lifestyle interventions for people with serious mental illness, like the RENEW program, focuses on weight loss and health improvements, but does not specifically address safety concerns. Generally, lifestyle interventions are considered safe, but it's important to consult with a healthcare provider for personalized advice. ^{6 7 8 9 10}

How is the Healthy ReStart treatment different from other treatments for mental illness?

The Healthy ReStart treatment is unique because it focuses on lifestyle interventions, which may include changes in diet, exercise, and other daily habits, to improve mental health, rather than relying solely on medication or traditional therapy. ^{6 10 11 12 13}

Eligibility Criteria

This trial is for adults over 18 with serious mental illness, as defined by DSM 5, who have experienced significant life disruptions. Participants must be part of a collaborating mental health agency, able to give informed consent, and have internet access for online sessions. It's not suitable for those with cognitive impairments that prevent informed consent or non-English speakers.

Inclusion Criteria

Access to the Internet for online meetings

Membership in a collaborating community mental health agency

Able to provide informed consent

Exclusion Criteria

I cannot communicate in English.

I am unable to understand and give consent due to cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an intervention with health coaching, motivational interviewing, positive psychology, and online wellness tools

6 months

Regular follow-ups with health coach

Follow-up

Participants are monitored for changes in mental and physical health, functioning, and recovery

6 months

Treatment Details

Interventions

• Healthy ReStart

Trial Overview The study examines the 'Healthy ReStart' intervention which includes health coaching, motivational talks, positive psychology techniques, and digital wellness tools versus standard services. The goal is to help mentally ill adults regain active lifestyles post major events like COVID-19.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Subjects receive an intervention with 4 components: establishing a working alliance with a health coach, completing an online inventory to assess personal wellness in eight life areas, developing a Restart plan that includes personalized life goals, and follow-along with a health coach to address barriers to goal attainment and to reinforce achievement.

Group II: Services as Usual Active Control 1 Intervention

Subjects receive mental health services as usual.

Healthy ReStart is already approved in United States for the following indications:

Approved in United States as Healthy ReStart Intervention for:

• Mental health recovery and functioning improvement post-major disruptions like COVID-19 pandemic

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Findings from Research

Providers trained in Person-Centered Care Planning (PCCP) often view medication adherence as essential for managing symptoms before pursuing recovery-oriented practices, which may conflict with the recovery movement's emphasis on autonomy.

Service users expressed mixed feelings about medication; while some found it beneficial, they also felt that the pressure to adhere to medication was inflexible and sometimes coercive, highlighting a gap between provider expectations and user experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"How do you try to have anyone comply or at least be pliable with you if that person's not even medicated?": Perspectives on the use of psychiatric medication within recovery-oriented practice. Jessell, L., Stanhope, V.[2023]

The Health Technology Program (HTP) was well-accepted by patients with schizophrenia spectrum disorders, with 96% rating it as satisfying, indicating a positive response to the integration of digital tools and human support.

Out of 200 patients, 87% utilized at least one digital tool, and they had an average of 28 contacts with a mental health technology coach, suggesting that the program effectively engaged patients in their relapse prevention plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction. Baumel, A., Correll, CU., Hauser, M., et al.[2018]

The brief three-month critical time intervention (B-CTI) significantly improved continuity of psychiatric outpatient care for 135 veterans with serious mental illness after discharge from inpatient treatment, leading to fewer days until their first outpatient service visit.

Participants in the B-CTI group had more outpatient visits and reported better support in managing appointments and community connections, indicating that this intervention effectively enhances postdischarge care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a critical time intervention to promote continuity of care after psychiatric inpatient hospitalization. Dixon, L., Goldberg, R., Iannone, V., et al.[2022]

The recovery model in mental health has led to the creation of new interventions and services that improve clinical and recovery outcomes for patients.

Despite its adoption by policymakers, transforming mental health systems to fully embrace recovery-oriented practices faces significant challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery in Schizophrenia: What Consumers Know and Do Not Know. Ahmed, AO., Marino, BA., Rosenthal, E., et al.[2022]

The Early Onset Treatment Program (EOTP) provides free, multidisciplinary treatment for young adults with serious mental illnesses, significantly reducing rehospitalization rates by 4.73 times at six months and 3.5 times at twelve months compared to a control group.

Participants in the EOTP also showed significant improvements in their symptoms and disability levels, highlighting the program's effectiveness in addressing the needs of high-need, high-cost patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customizing Early Intervention Treatment for Psychosis in the UTHealth - Harris County Psychiatric Center. Warner, AR., Shen, GC., Hamilton, JE., et al.[2021]

Lifestyle interventions for individuals with serious mental illness can lead to significant improvements in weight loss and metabolic syndrome risk factors, as shown in 12 out of 23 reviewed studies.

There is a notable lack of representation of racial and ethnic minority groups in these studies, which limits the generalizability of the findings, particularly for Hispanics and Asian Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions for adults with serious mental illness: a systematic literature review. Cabassa, LJ., Ezell, JM., Lewis-Fernández, R.[2021]

The RENEW weight loss intervention led to a modest weight loss in individuals with serious mental illness, with an average loss of 4.8 lbs at 3 months and 4.1 lbs at 6 months, compared to a weight gain of 6.2 lbs in the control group over 12 months.

The effectiveness of the RENEW intervention varied by setting, with certain sites showing greater success, achieving a weight loss of 9.4 lbs at 3 months and 10.9 lbs at 6 months, highlighting the importance of the environment in weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment response to the RENEW weight loss intervention in schizophrenia: impact of intervention setting. Brown, C., Goetz, J., Hamera, E., et al.[2022]

The STRIDE study is a 12-month randomized controlled trial involving 200 individuals with serious mental illness, aimed at addressing obesity and cardiovascular risks through a structured lifestyle intervention that includes weekly and monthly group sessions on nutrition and physical activity.

Participants in the study have high baseline obesity and cardiovascular risk factors, highlighting the urgent need for effective, evidence-based interventions tailored to this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications. Yarborough, BJ., Leo, MC., Stumbo, S., et al.[2021]

Incentive-based treatments have been shown to effectively reduce tobacco and other drug use among individuals with serious mental illness (SMI), highlighting their potential as a valuable intervention.

While there is limited research on the impact of these treatments on improving treatment attendance, medication use, and physical activity, initial evidence suggests positive outcomes, indicating a need for further investigation in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Tidey, JW.[2021]

The RENEW weight-loss program, which includes meal replacements and intensive nutrition and exercise instruction, led to significant weight loss in individuals with serious mental illness, with participants losing an average of 5.3 pounds at three months and 4.4 pounds at six months.

Participants in the control group experienced minimal weight changes, highlighting the effectiveness of the RENEW program in promoting weight loss regardless of the type of psychiatric medication taken.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. Brown, C., Goetz, J., Hamera, E.[2022]

A 40-year-old woman with severe psychiatric conditions, including dissociative identity disorder and bipolar disorder, experienced a complete resolution of her symptoms after participating in the 'Vital Mind Reset' online program, which involved lifestyle changes over 44 days.

This case suggests that when conventional treatments, including numerous medications and ECT, yield limited benefits and cause side effects, lifestyle interventions and dietary changes may be a viable first-line therapy for severe psychiatric illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing of Dissociative Identity Disorder, Borderline Personality Traits, and Bipolar Disorder Through Lifestyle Interventions: A Case Report. Brogan, K., Jarvi, A., Klopf, H., et al.[2022]

The Healthy Amistad program effectively improved health behaviors among individuals with serious mental illnesses, leading to significant weight loss (150 pounds total among 11 members) and increased physical activity.

Participants reported better health outcomes, including a decrease in emergency room visits from 58% to 37% and an increase in life satisfaction from 76% to 88%, demonstrating the program's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Amistad: improving the health of people with severe mental illness. Martin, MB., Martin, SL.[2019]

High intensity interval training (HIIT) has been shown to significantly reduce depression severity and improve various physical health metrics, such as cardiorespiratory fitness and HDL levels, in individuals with mental illnesses, based on a systematic review of 12 studies including 7 randomized controlled trials.

The review indicated that HIIT is safe, with no reported acute injuries, and participants showed good adherence to the training sessions, although dropout rates varied widely, highlighting the need for further research to improve retention in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high intensity interval training improve health outcomes among people with mental illness? A systematic review and preliminary meta-analysis of intervention studies across a range of mental illnesses. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

References

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

"How do you try to have anyone comply or at least be pliable with you if that person's not even medicated?": Perspectives on the use of psychiatric medication within recovery-oriented practice. [2023]

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

Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction. [2018]

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

Use of a critical time intervention to promote continuity of care after psychiatric inpatient hospitalization. [2022]

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

Recovery in Schizophrenia: What Consumers Know and Do Not Know. [2022]

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

Customizing Early Intervention Treatment for Psychosis in the UTHealth - Harris County Psychiatric Center. [2021]

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

Lifestyle interventions for adults with serious mental illness: a systematic literature review. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment response to the RENEW weight loss intervention in schizophrenia: impact of intervention setting. [2022]

8. England pubmed.ncbi.nlm.nih.gov

STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications. [2021]

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

Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. [2021]

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

Weight loss intervention for people with serious mental illness: a randomized controlled trial of the RENEW program. [2022]

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

Healing of Dissociative Identity Disorder, Borderline Personality Traits, and Bipolar Disorder Through Lifestyle Interventions: A Case Report. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Healthy Amistad: improving the health of people with severe mental illness. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Can high intensity interval training improve health outcomes among people with mental illness? A systematic review and preliminary meta-analysis of intervention studies across a range of mental illnesses. [2023]