Results Summary
What was the research about?
People with depression are four times more likely to die from heart disease than those without depression. Exercise like walking can improve symptoms of depression and prevent heart disease. But it can be hard for people with depression to find the desire and energy to exercise.
In this study, the research team compared three ways to encourage patients with depression who have or are at risk for heart disease to increase their daily steps:
- Fitbit® activity tracker, which tracks how many steps the wearer takes each day.
- Fitbit plus web-based cognitive behavioral therapy, or CBT. CBT helps patients change patterns in their thinking to encourage positive thoughts about exercise.
- Fitbit plus web-based, mindfulness-based cognitive therapy, or MBCT. MBCT helps patients become aware of their daily experiences that may prevent a healthy lifestyle.
What were the results?
After two months, the differences in daily steps across the three groups weren’t meaningful. The number of steps:
- Decreased by 8.2 steps per day for patients who received the Fitbit alone
- Increased by 2.9 steps per day for patients who also received CBT
- Increased by 2.8 steps per day for patients who also received MBCT
After four months, the three groups didn’t differ in the number of daily steps.
Who was in the study?
The study included 361 patients with depression who had or were at risk for heart disease. Of these patients, 83 percent were White, 7 percent were Black, 7 percent were more than one race, and 3 percent were another race; 7 percent were Hispanic. The average age was 45, 83 percent were women, and 92 percent had a college education or more.
What did the research team do?
The research team recruited patients from two Patient-Powered Research Networks, or PPRNs: MoodNetwork and Health eHeart. In PPRNs, patients, families, caregivers, and community members work closely with research teams to plan and conduct research. These PPRNs were part of PCORnet®.
The research team assigned patients by chance to one of three groups. Patients in all groups wore a Fitbit activity tracker for two months. In the first group, patients just wore the Fitbit. In the second group, patients viewed weekly, self-guided web-based courses using CBT for two months. In the third group, patients viewed weekly, self-guided web-based courses using MBCT for two months. Both courses encouraged patients to practice skills taught in each week’s course.
Patients in all groups filled out surveys every other week for the first two months and a final survey two months later.
Patients from the two PPRNs helped create research questions and plan the study.
What were the limits of the study?
Most patients were women, White, and had a college degree. Results may have differed if the study included patients with different backgrounds.
Future research could test the two types of therapy with live support from a coach or therapist.
How can people use the results?
Researchers can use the results when considering other ways to encourage patients with depression to exercise.
| How this project fits under PCORI’s Research Priorities MoodNetwork and Health eHeart online networks formerly were a Network Partner in PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute (PCORI). |
Professional Abstract
Objective
To evaluate whether internet-based, self-guided cognitive behavioral therapy (CBT) or mindfulness-based cognitive therapy (MBCT) in addition to an activity tracker (Fitbit®) increased daily steps compared with an activity tracker alone among patients with depression who have or are at risk for cardiovascular disease (CVD).
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 361 patients with self-reported bipolar or unipolar depression who have or are at risk for CVD; patients were from 2 PCORnet® PPRNs |
| Interventions/ Comparators |
|
| Outcomes |
Physical activity measured as the number of steps per day |
| Timeframe | 2-month follow-up for primary outcome |
This randomized controlled trial compared the effectiveness of two types of internet-based, self-guided mental health treatment plus activity tracking versus activity tracking alone on increasing physical activity in patients with depression who have or are at risk for CVD.
Researchers recruited patients from two Patient-Powered Research Networks (PPRNs), MoodNetwork and Health eHeart. These PPRNs were previously Network Partners in PCORnet®, the National Patient-Centered Clinical Research Network. In PPRNs, patients, caregivers, and community members contribute to all aspects of research.
Researchers randomized patients to one of three groups. In all groups, patients wore a Fitbit activity tracker for two months.
In the first group, patients viewed weekly, web-based CBT courses for two months. The CBT courses included content that could help patients change patterns in their thinking to encourage positive thoughts about physical activity. In the second group, patients viewed a weekly, web-based MBCT course for two months. The MBCT course included content on building awareness of daily experiences to understand impediments to a healthy lifestyle. Both courses encouraged patients to practice skills taught in each week’s course. In the third group, patients wore a Fitbit for two months and did not view any courses.
Patients completed surveys every other week for the first two months and again two months after the courses ended.
The study included 361 patients with bipolar or unipolar depression who had or were at risk for CVD. Of these patients, 83% were White, 7% were Black, 7% were more than one race, and 3% reported another race; 7% were Hispanic. The average age was 45, 83% were female, and 92% had a college degree or higher.
Patients from the two PPRNs helped create research questions and plan the study.
Results
After two months, differences in daily steps across the three groups were statistically significant but not clinically meaningful. The number of steps (all p<0.05):
- Decreased by 8.2 steps per day for patients who received the Fitbit alone
- Increased by 2.8 steps per day for patients who also received MBCT
- Increased by 2.9 steps per day for patients who also received CBT
At four months, the three groups did not differ significantly in number of daily steps.
Limitations
Most study participants were female, White, and had a college degree. Results may have differed if the study included participants with different backgrounds.
Conclusions and Relevance
In this study, an activity tracker with or without internet-based, self-guided mental health treatments did not meaningfully increase daily steps among patients with depression who have or are at risk for CVD.
Future Research Needs
Future research could test the CBT and MBCT interventions with live support from a coach or therapist.
| How this project fits under PCORI’s Research Priorities MoodNetwork and Health eHeart online networks formerly were a Network Partner in PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute (PCORI). |
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
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 questioned the researchers’ approach to calculating their needed sample size, saying that sample size should be calculated based on the minimal effect of interest, or the minimal difference between groups that would be clinically important. The researchers clarified that there was no previous evidence of a reliable minimum clinical difference for the outcome measures that they could use to calculate the sample size.
- Reviewers were particularly concerned that some study participants were not included in the analyses because they had not submitted any data from their activity monitors, questioning whether the researchers conducted their analyses based on the intention-to-treat principle or on how the participants were randomized. The researchers pointed to a supplementary table where they had compared the demographic characteristics of the participants who provided some activity data to those who provided none. They also acknowledged that their analyses were completed with all available data, which is not intention-to-treat.
- Reviewers noted that the authors’ description of their methods to account for missing data was written in future tense. The researchers explained that there was no agreed-upon method for controlling for missing data when data from an activity monitor were not even available at the baseline assessment. The researchers said they used future tense in this section because at the time of writing they had not yet performed all of the sensitivity analyses they planned to account for the missing activity data.