Lifestyle Physical Activity for Depression and Alcoholism

(HEART Trial)

Overseen By Debra Herman, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Substance use disorder, Psychotic disorder, Suicidality, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

214 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a Lifestyle Physical Activity (LPA) program, supported by technology like a Fitbit, can help women with depression avoid relapse during alcohol treatment. Participants are divided into two groups: one receives the LPA program plus a Fitbit, while the other receives only the Fitbit. This trial suits women struggling with depression who are currently in treatment for alcohol use, particularly those who are not very active in their daily lives. As an unphased trial, it offers participants a unique opportunity to explore innovative ways to support their mental and physical health during recovery.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technology-supported lifestyle physical activity intervention is safe for women with depression and alcoholism?

Research has shown that Lifestyle Physical Activity (LPA) is a safe and effective way to improve mental health. In studies, participants walked about 9,174 steps each day while using a Fitbit, demonstrating consistent activity without issues.

The LPA program specifically supports women recovering from depression and alcohol addiction. It offers a flexible method to manage stress, making it both safe and helpful in reducing the chance of relapse.

Overall, evidence suggests that regular physical activity like LPA is well-tolerated and enhances mental health and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Lifestyle Physical Activity (LPA) for depression and alcoholism because it offers a holistic approach that differs from typical treatments like medication and therapy. This method emphasizes integrating more physical activity into daily life, which can naturally boost mood and reduce alcohol cravings without the side effects medications might have. Additionally, the use of a Fitbit in this approach allows for real-time tracking and personalized feedback, which can motivate participants to stay active and engaged in their recovery process. By promoting self-awareness and empowerment, LPA has the potential to enhance mental and physical well-being in a unique and sustainable way.

What evidence suggests that this trial's treatments could be effective for depression and alcoholism?

Research has shown that the Lifestyle Physical Activity (LPA) program, especially when combined with a Fitbit, holds promise for women dealing with both depression and alcohol use disorder (AUD). In this trial, participants in the LPA+Fitbit group will receive the Lifestyle Physical Activity intervention along with a Fitbit to track activity data. Studies have found that this approach improves mental health and increases physical activity. Specifically, participants in earlier studies reported feeling less depressed and experiencing a reduced urge to drink. On average, they walked about 9,174 steps per day with the help of a Fitbit, which kept them active. This suggests that combining exercise with technology can effectively support mental health and reduce alcohol cravings. ^{1 2 6 7 8}

Who Is on the Research Team?

Ana Abrantes, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 18-65 with depression who are currently in alcohol treatment, own a smartphone, and lead a sedentary lifestyle (less than 150 minutes of moderate exercise per week). They must score at least 5 on the PHQ-9 depression scale. Women can't join if they have certain medical conditions, severe substance use disorders, current pregnancy or intent to become pregnant soon.

Inclusion Criteria

You haven't been physically active or exercising enough in the past 3 months (less than 150 minutes per week of moderate-intensity exercise).

You are currently receiving treatment for alcohol addiction.

I own a smartphone compatible with health tracking apps.

Exclusion Criteria

current pregnancy or intent to become pregnant during the next 12 weeks

I have never had a psychotic disorder or current symptoms.

current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a Lifestyle Physical Activity intervention with Fitbit or Fitbit Only control condition

12 weeks

3 visits (in-person) for EMA data collection

Follow-up

Follow-up assessments occur at 6 weeks, end of treatment at 3 months, and 6, 9, and 12 months

12 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fitbit Only
• Lifestyle Physical Activity (LPA)

Trial Overview The study is testing whether a Lifestyle Physical Activity (LPA) program supported by technology like Fitbit helps prevent relapse in these women. Participants will be randomly placed into two groups: one doing LPA with Fitbit and another using only the Fitbit.

How Is the Trial Designed?

Group I: LPA+Fitbit Experimental Treatment 1 Intervention

Participants in this group receive a Lifestyle Physical Activity intervention and are provided with a Fitbit to collect activity data

Group II: Fitbit Only Active Control 1 Intervention

Participants in this group are provided with a Fitbit to collect activity data

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A 12-week pilot study involving 20 depressed women in alcohol treatment showed that using a lifestyle physical activity (LPA) intervention with a Fitbit significantly helped participants cope with negative emotions and cravings, with 44% remaining abstinent throughout the treatment.

Participants reported high satisfaction with the intervention and increased use of physical activity as a coping strategy, suggesting that this approach could be a valuable tool for reducing relapse risk in women recovering from alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Fitbit-supported lifestyle physical activity intervention for depressed alcohol dependent women. Abrantes, AM., Blevins, CE., Battle, CL., et al.[2019]

In a study of 89 inpatients with substance use disorders over 6 months, moderate physical activity was associated with lower depressive symptoms, as measured by the Becks Depression Inventory II (BDI-II).

Although higher physical activity levels correlated with lower depression scores in a dose-dependent manner, the overall decline in depressive symptoms over time was not linked to increased physical activity, suggesting other factors may also play a significant role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Regular Physical Activity and Depressive Symptoms Among Patients in Treatment of Alcohol and Substance Use Disorders. Berger, E., Bolstad, I., Lien, L., et al.[2023]

Leisure-time physical activity (LTPA) significantly reduces the risk of developing depression in women, with active women being less likely to report depression over a four-year follow-up compared to inactive women.

Women who stop engaging in LTPA, especially those who are divorced, separated, or widowed, face a 4.2 times higher risk of developing depression, highlighting the importance of maintaining physical activity for mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leisure-time physical activity and marital status in relation to depression between men and women: A prospective study. Wang, F., DesMeules, M., Luo, W., et al.[2011]

In a study involving 36 patients with major depressive disorder, many found the Fitbit helpful for increasing physical activity, highlighting benefits like self-awareness and goal-setting, which align with existing research on physical activity and depression.

However, some patients reported negative experiences, such as inconvenience and inaccuracies, indicating that while Fitbits can be beneficial, their limitations should be considered when used alongside behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of the Fitbit in behavioural activation therapy for depression: a qualitative study. Chum, J., Kim, MS., Zielinski, L., et al.[2023]

The study is testing a new intervention called BAcPAc, which combines behavioral activation with physical activity promotion, to help depressed adults improve both their mental and physical health; it involves 60 participants and aims to assess feasibility and acceptability before a larger trial.

The pilot trial will evaluate various health outcomes, including depression severity and physical activity levels, over a 12-month period, with the goal of informing a definitive trial on the intervention's effectiveness in reducing depression and preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc). Farrand, P., Pentecost, C., Greaves, C., et al.[2022]

In a study of 25 patients recovering from alcohol use disorder, only 56% engaged in moderate-intensity physical activity, and the average daily step count was 8183 steps, indicating low levels of structured exercise in their natural environments.

While increased daily steps were linked to slightly higher positive feelings and lower alcohol cravings, the overall effects were minimal, suggesting that natural physical activity may only benefit a small number of individuals in recovery from alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Ecological Momentary Assessments and Fitbit Data to Examine Daily Associations Between Physical Activity, Affect and Alcohol Cravings in Patients with Alcohol Use Disorder. Stevenson, BL., Kunicki, ZJ., Brick, L., et al.[2023]

In a 28-day inpatient treatment program for adult alcoholics, an exercise intervention significantly reduced state and trait anxiety, as well as depression, compared to a control group.

While the exercise program improved mental health outcomes, it did not show significant effects on self-concept or aerobic capacity, suggesting that the psychological benefits of exercise may be more pronounced than physical fitness improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult inpatient alcoholics: physical exercise as a treatment intervention. Palmer, J., Vacc, N., Epstein, J.[2019]

Among 2,262 chronically-ill older adults with type 2 diabetes, those who engaged in moderate-to-vigorous physical activity (MVPA) within the WHO guidelines (600-<1,200 MET.min.week-1) had 28% lower odds of experiencing Major Depression compared to those who did not meet these guidelines.

To reduce depressive symptoms, a higher dose of MVPA (1200-<2,400 MET.min.week-1) was necessary, resulting in a 13% lower rate of symptoms, indicating that increasing physical activity levels can be crucial for mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for depression among the chronically Ill: Results from older diabetics in the Irish longitudinal study on ageing. Laird, E., Herring, MP., Carson, BP., et al.[2023]

In a study of 258 patients with clinically confirmed depression, baseline leisure-time physical activity (LTPA) did not significantly influence the five-year prognosis for recovery from depression, as 29% still exhibited depressive symptoms at follow-up.

However, higher levels of baseline LTPA were linked to increased total physical activity after five years, suggesting that promoting physical activity could be beneficial for overall health management in depressed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does baseline leisure-time physical activity level predict future depressive symptoms or physical activity among depressive patients? Findings from a Finnish five-year cohort study. Raatikainen, I., Mäntyselkä, P., Heinonen, A., et al.[2022]

Physical activity interventions have a moderate and significant antidepressant effect on adolescents with depression, with an effect size of -0.47 based on a meta-analysis of 9 studies involving 431 participants.

To maximize effectiveness, physical activity sessions should be of at least moderate intensity, and while the treatments are generally well accepted, the low quality of the studies suggests that further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. Oberste, M., Medele, M., Javelle, F., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5624522/

Developing a Fitbit-Supported Lifestyle Physical Activity ... An average of 9,174 steps/day were taken on the days the Fitbit was worn. Participants completed 4.7 of the 6 scheduled phone PA counseling sessions (78%).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02705898

Lifestyle Physical Activity Intervention for Depressed ... Given the demonstrated benefits of exercise for decreasing depression, negative affect, and urges to drink, helping women engage in a flexible and acceptable ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924001188

A lifestyle physical activity intervention for women in ... LPA+Fitbit resulted in significant improvements in mental health outcomes, as well as self-reported physical activity, among women with AUD. Abstract ...

4. jsatjournal.com jsatjournal.com/article/S2949-8759(24)00118-8/abstract

A lifestyle physical activity intervention for women in ... LPA+Fitbit resulted in significant improvements in mental health outcomes, as well as self-reported physical activity, among women with AUD.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28755778/

Developing a Fitbit-supported lifestyle physical ... - PubMed Results: Participants wore their Fitbit on 73% of days during the intervention period. An average of 9174 steps/day were taken on the days the Fitbit was worn.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547217301083

Developing a Fitbit-supported lifestyle physical activity ... An average of 9174 steps/day were taken on the days the Fitbit was worn. Participants completed 4.7 of the 6 scheduled phone PA counseling sessions (78%). Among ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11562388/

A Novel Scale of Lifestyle Physical Activity: Measure ... Engaging in physical activity is strongly associated with improved mental health and health-related quality of life as well as a reduced risk of ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/263313

Testing a Lifestyle Physical Activity Intervention for Women With ... The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse ...