Clinical trial NCT00867776: Creating African-American Wellness Through Exercise
Official title: Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Depression
African Americans
Exercise
Culturally tailored intervention
Health disparities
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: African American Health Coalition
First posted: 2009-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Several studies have documented the effectiveness of exercise as a treatment for depression. However, these studies have used supervised exercise in medical school or university environments and have included mostly middle-class White populations. Little is known regarding how to translate these findings to real world settings or to minority populations. Exercise may be a particularly beneficial option for African-Americans suffering from depression. African-Americans face significant disparities in depression care. At least a part of these disparities are due to lack of trust in the healthcare system and negative attitudes toward antidepressants. Our goal is to pilot-test a culturally-tailored, community-based exercise support program for depressed African-Americans. We will recruit participants who screened positive for moderate depressive symptoms when they enrolled in the African-American Health Coalition's Free Exercise Card Program, but who are exercising less than 3 times per week. They will participate in a 6-week educational self-care group focusing on how to use exercise and other self-help tools to reduce depressive symptoms. Participants will be encouraged to create action plans regarding exercise and other healthy lifestyle changes. Groups will also provide culturally-tailored information about depression therapies, such as antidepressants and psychotherapy, and discuss strategies for obtaining quality health care.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9)
timeFrame: Week 1 (pre-test) and week 6 (post-test)
Secondary outcomes:
measure: Frequency of exercise using the International Physical Activity questionnaire(IPAQ).
timeFrame: Week 1 and Week 6
measure: Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS).
timeFrame: Week 1 and Week 6
measure: Use of guideline-concordant depression therapies
timeFrame: week 1 and week 6
measure: Acceptability of antidepressant therapy and counseling
timeFrame: week 1 and week 6
measure: Depression self-care behaviors
timeFrame: week 1 and week 6
measure: Satisfaction with program
timeFrame: week 6
measure: Attendance to sessions
timeFrame: Each week for 6 weeks
measure: Depression care self-efficacy
timeFrame: week 1 and week 6
Other outcomes:
Locations:
city: Portland
country: United States
facility: African American Health Coalition
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Christina M Nicolaidis, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: