Creating African-American Wellness Through Exercise

Depression Clinical Trial

Official title:

Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00867776
• Other study ID #: IRB00005105
• Status: Terminated
• Phase: N/A
• First received: March 23, 2009
• Last updated: October 30, 2015
• Start date: June 2009
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• AAHC Exercise Program Support Group
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.

Locations

Country	Name	City	State
United States	African American Health Coalition	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	African American Health Coalition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Frequency of exercise using the International Physical Activity questionnaire(IPAQ).		Week 1 and Week 6	No
Secondary	Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS).		Week 1 and Week 6	No
Secondary	Use of guideline-concordant depression therapies		week 1 and week 6	No
Secondary	Acceptability of antidepressant therapy and counseling		week 1 and week 6	No
Secondary	Depression self-care behaviors		week 1 and week 6	No
Secondary	Satisfaction with program		week 6	No
Secondary	Attendance to sessions		Each week for 6 weeks	No
Secondary	Depression care self-efficacy		week 1 and week 6	No