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Initiating and Maintaining Physical Activity in Depressed Individuals

NCT02691845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-12-28

No results posted yet for this study

Summary

The investigators propose a randomized clinical trial in which 240 depressed individuals are assigned to one of three arms, with each successive arm having an added component that may serve to increase and maintain physical activity:

1. brief advice (BA) to exercise (control condition);
2. BA + supervised \& home-based exercise (SHE) + health education (HE) contact control; and
3. BA + SHE+ cognitive-behavioral sessions focused on increasing and maintaining exercise (CBEX).

The primary aim is to assess and optimize the safety, feasibility, acceptability of each intervention component, as well as barriers limiting their effectiveness in order to prepare for a larger scale randomized clinical trial.

Conditions

Interventions

BEHAVIORAL

BA (brief advice)

BEHAVIORAL

SHE (supervised and home-based exercise)

BEHAVIORAL

HE (health education)

BEHAVIORAL

CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Lisa Uebelacker, PhD · Butler Hospital

  • Ana Abrantes, PhD · Butler Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02691845 on ClinicalTrials.gov