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Active, Not Recruiting

NCT Number: NCT04667520

Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment

The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. Participants are randomized to either 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments and EMA data will be collected.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Women develop AUD more quickly and suffer a broader range of adverse alcohol-related health consequences than men. Physical activity (PA) interventions may play an important role as an alternate coping strategy for women with AUD and a means to decrease relapse.

The primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (LPA) intervention for preventing relapse among women with depression engaged in alcohol treatment. A total of 214 women from the Alcohol and Drug Partial Hospitalization Program (ADP) at Butler Hospital with AUD and depression will be recruited and randomly assign them to either a: 1) LPA+Fitbit intervention or 2) Fitbit Only control condition. Follow-up assessments will occur at 6-weeks, end of treatment (EOT) at 3 months, and 6, 9 and 12 months. Participants will also complete 3, 10-day periods of ecological momentary assessment (EMA) during early recovery, at approximately weeks 1 & 2, 5 & 6, and again at weeks 11 & 12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • between 18 and 65 years of age
  • score of 5 or above on the PHQ-9 (need to have a score of 1 on questions 1 OR 2)
  • Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months)
  • are currently engaged in alcohol treatment
  • own a smartphone - to allow for EMA software and Fitbit application

Exclusion criteria

  • current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa
  • a history of psychotic disorder or current psychotic symptoms
  • current suicidality or homicidality
  • current mania
  • marked organic impairment according to either the medical record or responses to the diagnostic assessments
  • physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician)
  • current pregnancy or intent to become pregnant during the next 12 weeks

Treatment and study plan

Lifestyle physical activity (LPA)

Behavioral

This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.

Fitbit Only

Behavioral

Participants are provided with a Fitbit during their study participation.

Primary outcomes

  1. Percent of sample that is abstinent from alcohol

    Time frame: 12 months

    Timeline Follow-back Interview will be used to determined whether participants drank any alcohol during the time frame assessed.

Secondary outcomes

  1. Alcohol-Related Consequences

    Time frame: 12 months

    The Short Inventory of Problems will be used to measure the experience of alcohol-related consequences during the study period.

  2. Depressive symptoms

    Time frame: 12 months

    Symptoms of depression, as measured by the Patient Health Questionnaire-9

  3. Physical Activity levels

    Time frame: 12 months

    Objectively measured steps/day with a Fitbit

  4. Alcohol Abstinence Self-Efficacy

    Time frame: 12 months

    Alcohol abstinence self-efficacy, as measured by Alcohol Abstinence Self-Efficacy Scale

  5. Cardiorespiratory Fitness (estimated peak VO2)

    Time frame: 12 months

    Estimated VO2 max will be determined by the 6-minute Cycle Ergometer Exercise test

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: HEART

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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