DepressionPhase 1/2NCT06170255
Depression Treatment and Risk for Cardiovascular Disease
A Phase 1/2 study testing Behavioral Activation (BA) in people with Depression, run by East Carolina University.
Trial summary
This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation (BA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2014to 2 Oct 2017
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females age 21-75
- Meet diagnostic criteria for major depressive disorder
- Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.
- Levels of depressive symptoms of at least moderate level (beck depression inventory II score > 19 of 63 possible points; or a Hamilton depression rating scale > 12 of 50 possible points)
Who cannot join
- A verbal expression of current, significant, suicidal ideation; a score of > 15 on the beck scale for suicidal ideation
- Score of >1 on any single item of the Beck Scale for Suicidal Ideation
- Score of > 1 on the item assessing suicidal ideation on the beck depression inventory II.
- Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)
- Current use of an antidepressant medication
- Currently in psychotherapy.
- Current use of a beta blocker, anxiolytic (benzodiazepine), antipsychotic agent
- Diagnosis of CVD.
About this study
This study was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.
- Conditions
- Depression
- Being tested
- Behavioral Activation (BA)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation (BA)Behavioural
Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Depression treatment | Experimental | Participants receive behavioral therapy for depression Receives: Behavioral: Behavioral Activation (BA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility of the study including recruitment, enrollment, and retention rates
Measured: 2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)
Secondary outcomes (1)
Heart Rate Variability (HRV)
Change in HRV from enrollment to post-treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start6 Mar 2014
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Matthew Whited, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170255
- Sponsor's protocol ID
- 5K23HL109620
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Treatment and Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06170255
- Acronym / sponsor ID
- 5K23HL109620
- Conditions
- Depression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Mental Health (NIMH)
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 14 Dec 2023 (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 was designed to determine the feasibility of a Randomized Controlled Trial (RCT) that involved treating depression among participants with an elevated risk for cardiovascular disease. It is expected that treating depression through non-pharmacological means will impact heart rate variability, a proximal measure of CVD risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depression treatment | Experimental | Behavioral: Behavioral Activation (BA)Participants receive behavioral therapy for depression |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females age 21-75
- Meet diagnostic criteria for major depressive disorder
- Framingham risk score indicating a greater than negligible 10-year risk (3% or greater) for cardiovascular disease.
- Levels of depressive symptoms of at least moderate level (beck depression inventory II score > 19 of 63 possible points; or a Hamilton depression rating scale > 12 of 50 possible points)
Key exclusion criteria (8 listed)
- A verbal expression of current, significant, suicidal ideation; a score of > 15 on the beck scale for suicidal ideation
- Score of >1 on any single item of the Beck Scale for Suicidal Ideation
- Score of > 1 on the item assessing suicidal ideation on the beck depression inventory II.
- Psychiatric diagnoses that could potentially interfere with depression treatment (current post traumatic stress disorder, bipolar I disorder, obsessive-compulsive disorder, bulimia or anorexia nervosa, schizophrenia, and panic disorder)
- Current use of an antidepressant medication
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 |
|---|---|---|
| Behavioral Activation (BA)Behavioral activation involves an exploration of the patient's individualized values and follows with goal setting to improve depression symptoms. | Behavioural | Depression treatment |
Primary outcome
Feasibility
Time frame: 2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)
Feasibility of the study including recruitment, enrollment, and retention rates
1 secondary outcome
Heart Rate Variability (HRV)
Time frame: 12 weeks
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 14 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Behavioral Activation (BA) in people with Depression, run by East Carolina University.
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 4 inclusion and 8 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility (time frame: 2 years. Throughout the course of the study (number recruited/screened, number enrolled, number completing the study)). 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 14 Dec 2023.