Depressive SymptomsNCT03107039
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
A study testing Exercise and Health Education in people with Depressive Symptoms, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Exercise and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Jan 2020
- 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 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experiencing depression symptoms and generally healthy.
Who cannot join
- Anyone assessed to be unsafe to be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Teachers College, Columbia University
New York, New York, 10027
About this study
This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.
- Conditions
- Depressive Symptoms
- Being tested
- Exercise, Health Education
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A 12 week resistance exercise curriculum
Health EducationBehavioural
A 12 week health education curriculum
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | This arm will use a resistance exercise curriculum. Receives: Behavioral: Exercise |
| Health Education | Active comparator | This arm will use health education curriculum. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
The Quick Inventory of Depression Symptomatology will be used to assess depression.
Measured: 6 months
Secondary outcomes (1)
Blood lipids
Total cholesterol, HDL, LDL, and triglycerides will be assessed from a blood sample.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Sep 2016
- Primary completion1 Apr 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Ciccolo, PhD, Principal investigator, Teachers College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107039
- Sponsor's protocol ID
- 512156
- Status last verified
- Dec 2020
- First submitted
- 22 Mar 2017
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciccolo JT, Louie ME, SantaBarbara NJ, Webster CT, Whitworth JW, Nosrat S, Chrastek M, Dunsiger SI, Carey MP, Busch AM. Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy. BMC Psychiatry. 2022 Apr 21;22(1):283. doi: 10.1186/s12888-022-03935-x.
PubMed 35448974Busch AM, Louie ME, SantaBarbara NJ, Ajayi AA, Gleason N, Dunsiger SI, Carey MP, Ciccolo JT. Effects of resistance training on depression and cardiovascular disease risk in Black men: Protocol for a randomized controlled trial. Ment Health Phys Act. 2019 Oct;17:100299. doi: 10.1016/j.mhpa.2019.100299. Epub 2019 Sep 12.
PubMed 32863882
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men
- ClinicalTrials.gov ID
- NCT03107039
- Acronym / sponsor ID
- 512156
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 group
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThis arm will use a resistance exercise curriculum. |
| Health Education | Active comparator | Behavioral: Health EducationThis arm will use health education curriculum. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Experiencing depression symptoms and generally healthy.
Key exclusion criteria (1 listed)
- Anyone assessed to be unsafe to be enrolled.
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 |
|---|---|---|
| ExerciseA 12 week resistance exercise curriculum | Behavioural | Exercise |
| Health EducationA 12 week health education curriculum | Behavioural | Health Education |
Primary outcome
Depression symptoms
Time frame: 6 months
The Quick Inventory of Depression Symptomatology will be used to assess depression.
1 secondary outcome
Blood lipids
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 35448974Ciccolo JT, Louie ME, SantaBarbara NJ, Webster CT, Whitworth JW, Nosrat S, Chrastek M, Dunsiger SI, Carey MP, Busch AM. Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy. BMC Psychiatry. 2022 Apr 21;22(1):283. doi: 10.1186/s12888-022-03935-x.
- Derived from this study: PubMed 32863882Busch AM, Louie ME, SantaBarbara NJ, Ajayi AA, Gleason N, Dunsiger SI, Carey MP, Ciccolo JT. Effects of resistance training on depression and cardiovascular disease risk in Black men: Protocol for a randomized controlled trial. Ment Health Phys Act. 2019 Oct;17:100299. doi: 10.1016/j.mhpa.2019.100299. Epub 2019 Sep 12.
- Individual participant dataSharing planned: No
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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.
Joseph Ciccolo, PhD principal investigator
Teachers College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Health Education in people with Depressive Symptoms, run by Teachers College, Columbia 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Dec 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107039, which also lists 2 linked publications.
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 23 Dec 2020.