Project Summary
PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Bipolar disorder is a brain disorder that causes people to have periods of unstable moods. People with bipolar disorder may have problems focusing and sleep less than normal while feeling high energy. People with bipolar disorder may also feel sad or hopeless or want to hurt themselves. Bipolar disorder often begins during childhood or the teenage years.
Medicines called second-generation antipsychotics are used to treat bipolar disorder but can cause side effects, including weight gain. Youth and their parents find weight gain to be the most difficult side effect. Healthy eating, exercising, and other activities that encourage a healthy lifestyle may help patients avoid weight gain. Taking a medicine called metformin may also help control weight gain. However, researchers have only studied these weight control options for short time periods in controlled settings. This makes it hard to know whether these treatments will work over longer periods of time for patients treated outside of research settings.
This study looks at two ways to help manage weight gain and overall health in youth with bipolar disorder: using a program to help youth and families make healthy choices, or using that program along with metformin.
Who can this research help?
The results of this research may help overweight and obese youth with bipolar disorder prevent or manage weight gain.
What is the research team doing?
Researchers are recruiting 1,800 overweight or obese youth ages 8 to 19 years old who have bipolar disorder and take medicine that can cause weight gain. Researchers are recruiting these youth from 24 private and community mental health clinics in the Greater Cincinnati and New York City regions.
The researchers assign all youth in the study to use LIFE, a program that guides youth and their families in making healthy eating plans, exercising, and avoiding activities with little or no exercise. The research team is assigning half the youth in the study by chance to receive metformin in addition to this program. The research team is testing both options to see whether they improve weight change, blood pressure, blood sugar, and cholesterol. The team is also looking at how each treatment affects self-esteem, mood, and quality of life. Finally, the team is also looking at how often youth take their medicine and how satisfied youth are with their treatment.
Before the research project started, 497 patients, 344 caregivers, and 54 clinicians completed an online survey and gave their opinions on the study design. Patients, parents, and mental health advocates contribute to study decisions.
Research methods at a glance
| Design Element | Description |
|---|---|
| Study Design | Randomized controlled trial |
| Population | Overweight and obese youth ages 8 to 19 with a bipolar spectrum disorder who are taking a second-generation antipsychotic medicine |
| Interventions/ Comparators |
|
| Outcomes |
Primary: body weight Secondary: how regularly patients take their second-generation antipsychotic medication, how satisfied they are with taking the medicine, psychological effects (e.g., effects on mood or anxiety), quality of life |
| Timeframe | 2-year follow-up for primary outcome |
COVID-19-Related Study
Using Telehealth to Treat Youth with Bipolar Spectrum Disorder during the COVID-19 Pandemic -- The MOBILITY Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
Bipolar spectrum disorder, or BSD, is a health problem that causes people to have periods of unstable mood. Youth with BSD may have faced challenges in getting mental health treatment during the COVID-19 pandemic.
In this study, the research team wanted to learn how the use of telehealth during the pandemic affected youth with BSD. Telehealth is a way to provide care remotely using phone or video. During the pandemic, most mental health care moved from in-person care to telehealth.
The research team surveyed and interviewed youth, caregivers, and clinicians about youths’ well-being, mental health care, and other outcomes. The team compared youth who:
- Used telehealth therapy through phone or video
- Used in-person therapy
- Didn’t use therapy
What were the results?
Compared with youth who didn’t use therapy, youth who used in-person or telehealth therapy reported more:
- Symptoms of depression
- Substance use
- Emergency room visits for mental health
This finding doesn’t mean that therapy made youth feel worse. It may be that youth who sought therapy had worse symptoms than those who didn’t seek therapy.
Youth who used telehealth had better functioning and less mania and mood instability than youth who used in-person therapy. Youth who used telehealth and in-person therapy didn’t differ in:
- Well-being, depression, or anxiety
- Use of mental health care or medicine to treat BSD
- Trauma or suicidal thoughts
- Substance use
- Challenges in getting mental health services
- Willingness to get a COVID-19 vaccine
Among youth using telehealth:
- Youth who used telehealth more often had more suicidal thoughts and emergency room visits for mental health.
- Youth who used video telehealth were less depressed and anxious than those who used phone telehealth.
- Youth who used video to manage their medicines with a doctor felt less neglected than those who used the phone.
Clinicians said their thoughts about telehealth had improved since March 2020. They felt confident in using telehealth and said it didn’t interfere with providing care.
Who was in the study?
The study included 316 youth with BSD, 363 caregivers, and 57 clinicians. All youth received care at hospitals in the Northeast, the Midwest, Texas, or California. Of youth, 68 percent were White, 18 percent were Black, and 14 percent were another race; 14 percent were Hispanic. The average age of youth was 16, and 54 percent were male.
What did the research team do?
The study took place between December 2020 and October 2021. The research team sent surveys to youth and caregivers and interviewed them at the start of the study and six months later. Clinicians completed interviews about telehealth between January and May 2021.
Youth with BSD, caregivers, and clinicians gave input throughout the study.
What were the limits of the study?
The research team can’t say for sure that the mental health outcomes were due to therapy or that youth with more severe symptoms used therapy. Fewer people took part in the study than planned; results may have differed if more people took part.
How can people use the results?
Clinicians can use these results when considering how to treat youth with BSD.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Youth with mental health conditions may have faced challenges during the COVID-19 pandemic, especially in obtaining mental health treatment. During the pandemic, health systems shifted from in-person visits to telehealth. Telehealth is a way to provide care to patients remotely using phone or video.
Objective
To explore the effect of using telehealth to treat youth with bipolar spectrum disorder (BSD) during the COVID-19 pandemic
Study Design
| Design Element | Description |
|---|---|
| Design | Mixed methods |
| Population | 316 youth with BSD receiving care at hospitals in the Northeast, the Midwest, Texas, and California, 363 caregivers, and 57 clinicians; youth and caregivers were enrolled in an ongoing study for youth with BSD with obesity or overweight who were taking second-generation antipsychotics |
| Outcomes |
Primary: overall functioning Secondary: delivery and frequency of mental health care, BSD medication adherence, depression, anxiety, trauma, suicidal ideation, substance use, COVID-19 vaccine hesitancy, and barriers to receiving mental health services |
| Data Collection Timeframe | Youth and caregiver surveys and interviews: December 2020–October 2021 Clinician surveys: January 2021–May 2021 |
This study explored how the use of telehealth during the pandemic affected functioning, BSD medication adherence, symptom severity, COVID-19 vaccine hesitancy, and barriers to receiving mental health care among youth with BSD. Researchers compared youth using telehealth therapy via telephone or video, youth using in-person therapy, and youth who were not using therapy. Researchers did not randomly assign youth to the type of therapy.
Youth and caregivers completed surveys and interviews at baseline and six months later. Surveys asked about mental health care, functioning, and impairment. Researchers also interviewed clinicians about changes in their perceptions of telehealth since March 2020.
The study included 316 youth with BSD, 363 caregivers, and 57 clinicians. Of youth, 68% were White, 18% were Black, and 14% were another race; 14% were Hispanic. The average age of youth was 16, and 54% were male.
Youth with BSD, caregivers, and clinicians gave input throughout the study.
Results
Compared with youth who did not use any therapy, youth who used either telehealth or in-person therapy reported worse depression and higher rates of substance use and psychiatric emergency room visits (all p≤0.05). The two treatment groups did not differ significantly in other outcomes.
Youth who used telehealth reported higher overall functioning and less mania and mood instability (all p≤0.01) than youth who only used in-person therapy. Telehealth and in-person therapy did not differ significantly in other outcomes.
Among youth using telehealth therapy:
- Higher frequency of telehealth visits was associated with greater suicidal ideation and more psychiatric emergency room visits (both p≤0.01).
- Youth who used video telehealth were less depressed and anxious than youth who used telephone telehealth (both p≤0.01).
- Youth who used video for medication management were less likely to report feelings of neglect than youth who used telephone telehealth (p=0.01).
Clinicians reported that their perceptions of telehealth improved since March 2020. They also reported feeling confident in using technology and that telehealth did not decrease productivity.
Limitations
Researchers could not determine whether the outcomes among youth were the result of using therapy or if youth with more severe symptoms at baseline sought therapy or used it more often. The sample size was smaller than planned, which potentially limited the ability to detect differences between groups.
Conclusions and Relevance
In this study, youth with BSD who used in-person or telehealth therapy had unfavorable outcomes compared with youth who were not using therapy. However, among youth who used therapy, telehealth, especially video telehealth, had more favorable outcomes than in-person therapy.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked whether the researchers identified any patient characteristics that predicted their use of telemental health services and adjusted for those patient characteristics in their analyses. The researchers acknowledged that patients who had teletherapy via video had higher incomes than patients using phone-based teletherapy or in-person treatment, but the number of outcomes related to income was consistent with chance, so income was unlikely to be a major confounder.
- The reviewers noted some unexpected associations in the treatment response heterogeneity analyses and asked the researchers to add their thoughts about these associations to the report’s discussion section. The researchers explained that they did not feel that these results were clinically meaningful because the small number of notable responses was less than would be predicted by chance. They chose to refer to these results as exploratory and referred to the direction of these results, identifying the results as marginally significant.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by December 2023.
