Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT04667520

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

Led by Butler Hospital · Updated on 2025-04-06

214

Participants Needed

1

Research Sites

268 weeks

Total Duration

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Sponsors

B

Butler Hospital

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Between 18 and 65 years of age
  • Score of 5 or above on the PHQ-9 with a score of 1 on question 1 or 2
  • Sedentary or low active (less than 150 minutes per week of moderate-intensity exercise for the past 3 months)
  • Currently engaged in alcohol treatment
  • Own a smartphone to use EMA software and Fitbit application
Not Eligible

You will not qualify if you...

  • Current moderate or severe substance use disorder or anorexia or bulimia nervosa
  • History of psychotic disorder or current psychotic symptoms
  • Current suicidality or homicidality
  • Current mania
  • Marked organic impairment based on medical records or diagnostic assessments
  • Physical or medical problems that prevent safe participation in moderate intensity physical activity (not medically cleared by study physician)
  • Current pregnancy or planning to become pregnant within the next 12 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Butler Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

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Research Team

A

Ana Abrantes, PhD

CONTACT

D

Debra Herman, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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