NCT00867776

Brief Summary

The purpose of this study is to pilot-test a culturally-tailored, community-based educational program for African-Americans, focusing on how to use exercise and other self-management strategies to reduce depressive symptoms and improve health. This study will explore what type of additional support would encourage depressed African-Americans to exercise regularly. The investigators hypothesize that participants will report greater frequency of exercise and lower depression scores at the end of the program than they did at baseline. However, this study is not adequately powered to test this hypothesis - the main goal is to assess feasibility, acceptability and satisfaction of the pilot intervention.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

March 23, 2009

Last Update Submit

October 30, 2015

Conditions

Depression

Keywords

DepressionAfrican AmericansExerciseCulturally tailored interventionHealth disparities

Outcome Measures

Primary Outcomes (1)

  • Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9)

    Week 1 (pre-test) and week 6 (post-test)

Secondary Outcomes (8)

  • Frequency of exercise using the International Physical Activity questionnaire(IPAQ).

    Week 1 and Week 6

  • Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS).

    Week 1 and Week 6

  • Use of guideline-concordant depression therapies

    week 1 and week 6

  • Acceptability of antidepressant therapy and counseling

    week 1 and week 6

  • Depression self-care behaviors

    week 1 and week 6

  • +3 more secondary outcomes

Study Arms (1)

AAHC Excercise Program Support Group

EXPERIMENTAL

Participants taking part in the AAHC Exercise Program Support Group (the intervention).

Behavioral: AAHC Exercise Program Support Group

Interventions

AAHC Exercise Program Support GroupBEHAVIORAL

6-week community-based, culturally tailored support group program, focusing on exercise and healthy lifestyle habits. Groups will also include basic psychoeducation about depression and depression care. Groups will have up to 20 participants and will meet weekly for 2 hours. By the end of the program, participants will be encouraged to create a personalized action plan focusing on exercise and other healthy lifestyle choices.

Also known as: Support group, Psychoeducation, Exercise support, Self-care
AAHC Excercise Program Support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • African-American or of African-American descent
  • Currently participating in the African-American Health Coalition Free Exercise-Card Program
  • Experiencing moderate depressive symptoms, as indicated by a score of 10-20 on the Depression Scale of the Patient Health Questionnaire (PHQ-9.
  • Exercising less than three times per week (for a minimum of 30 minutes per session) over the past month

You may not qualify if:

  • Actively suicidal
  • If a health care provider, AAHC staff member, or an investigator feel that participation in the program may endanger the participant's health or safety.
  • Known mental or cognitive impairments
  • Known condition that precludes their ability to feasibly participate in a support group session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

African American Health Coalition

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Self-Help GroupsSelf Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsTherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christina M Nicolaidis, MD,MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 24, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 3, 2015

Record last verified: 2015-10

Locations

US(1)