DepressionNCT00867776
Creating African-American Wellness Through Exercise
A study testing AAHC Exercise Program Support Group in people with Depression, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- AAHC Exercise Program Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
African American Health Coalition
Portland, Oregon, 97227
About this study
Official title: Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health
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.
Read the 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.
- Conditions
- Depression
- Being tested
- AAHC Exercise Program Support Group
- Keywords
- Depression, African Americans, Exercise, Culturally tailored intervention, Health disparities
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAHC Exercise Program Support GroupBehavioural
Also called Support group, Psychoeducation, Exercise support, Self-care
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.
| Study group | Role | What they receive |
|---|---|---|
| AAHC Excercise Program Support Group | Experimental | Participants taking part in the AAHC Exercise Program Support Group (the intervention). Receives: Behavioral: AAHC Exercise Program Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9)
Measured: Week 1 (pre-test) and week 6 (post-test)
Secondary outcomes (8)
Frequency of exercise using the International Physical Activity questionnaire(IPAQ).
Measured: Week 1 and Week 6
Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS).
Measured: Week 1 and Week 6
Use of guideline-concordant depression therapies
Measured: week 1 and week 6
Acceptability of antidepressant therapy and counseling
Measured: week 1 and week 6
Depression self-care behaviors
Measured: week 1 and week 6
Satisfaction with program
Measured: week 6
Attendance to sessions
Measured: Each week for 6 weeks
Depression care self-efficacy
Measured: week 1 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: We decided to alter the intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- African American Health Coalition
- Responsible party
- Principal investigator, Christina M. Nicolaidis, Oregon Health and Science University
- Investigators
- Christina M Nicolaidis, MD,MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867776
- Sponsor's protocol ID
- IRB00005105
- Status last verified
- Oct 2015
- First submitted
- 23 Mar 2009
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating African-American Wellness Through Exercise: Community Driven Strategies to Improve Health
- ClinicalTrials.gov ID
- NCT00867776
- Acronym / sponsor ID
- IRB00005105
- Conditions
- Depression
- Keywords
- Depression, African Americans, Exercise, Culturally tailored intervention, Health disparities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We decided to alter the intervention.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- African American Health Coalition
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAHC Excercise Program Support Group | Experimental | Behavioral: AAHC Exercise Program Support GroupParticipants taking part in the AAHC Exercise Program Support Group (the intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAHC Exercise Program Support GroupAlso: Support group, Psychoeducation, Exercise support, Self-care6-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. | Behavioural | AAHC Excercise Program Support Group |
Primary outcome
Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9)
Time frame: Week 1 (pre-test) and week 6 (post-test)
8 secondary outcomes
Frequency of exercise using the International Physical Activity questionnaire(IPAQ).
Time frame: Week 1 and Week 6
Attitudes about exercise, exercise self-efficacy and readiness to exercise using physical activity assessment scale (PAAS).
Time frame: Week 1 and Week 6
Use of guideline-concordant depression therapies
Time frame: week 1 and week 6
Acceptability of antidepressant therapy and counseling
Time frame: week 1 and week 6
Depression self-care behaviors
Time frame: week 1 and week 6
Satisfaction with program
Time frame: week 6
Attendance to sessions
Time frame: Each week for 6 weeks
Depression care self-efficacy
Time frame: week 1 and week 6
Results and safety
The study was stopped early (reason given: We decided to alter the intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Nicolaidis, MD,MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAHC Exercise Program Support Group in people with Depression, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We decided to alter the intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression severity, as measured by the Depression Scale of the Patient Health Questionnaire (PHQ-9) (time frame: Week 1 (pre-test) and week 6 (post-test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.