DiabetesBA-MEDICNCT02027259
Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits
A study testing Behavioral activation (BA) in people with Diabetes and Depression, run by Providence VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether group visits with added behavioral activation (BA) for depression will have a greater clinical impact than our standard group visits without BA for depression in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, 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
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2012to 2 Oct 2015
- 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
- Clinical diagnosis of type 2 diabetes
- Clinical diagnosis of depression
- PHQ-9 score ≥10 for depressive symptoms
- >= 18 years old
- a most recent HbA1c ≥8.0% within the previous 12 months in the chart; and
- have 1 or more of the following modifiable CVD risk factors not at target goals, defined as:
Show all 9Show fewer
- current smoker (any cigarette smoking <30 days),
- blood pressure >130/80 mm Hg, documented at least twice in the last 6 months
- LDL cholesterol >100 mg/dL within the last 12 months.
Who cannot join
- Inability to attend the group sessions
- active psychosis of any type or organic brain injury that precludes DM self- care
- type 1 diabetes as documented in the medical chart
- pregnancy
- actively suicidal and /or
- end-stage medical illness (e.g. metastatic cancer, awaiting organ transplant)
- Patients currently enrolled in DM group programs that include medication titration within the group setting would not be eligible due to co- intervention.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether group visits with added behavioral activation (BA) for depression will have a greater clinical impact than our standard group visits without BA for depression in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.
Read the detailed description
BACKGROUND Nearly 33% of the 24.5 million people in the US with diabetes mellitus (DM) have co-morbid depression. Since 65% of patients with DM die from cardiovascular disease (CVD), concomitant control of CVD risk factors along with glycemic control is crucial to prevent adverse outcomes. However, co-morbid depression makes DM and CVD risk factors harder to control. We demonstrated that a pharmacist-led group visit model consisting of: 1) pharmacotherapy management for DM, hyperlipidemia and hypertension, 2) self-management education, 3) case management and 4) behavioral strategies for DM and CVD self-care behaviors, was more efficacious in improving hyperglycemia and CVD risk factors compared to standard primary care controls in a general DM population and also for patients with DM and co-morbid depression. For participants with DM and depression there was also a non-significant trend toward improvement in depression despite the lack of depression treatment.
OBJECTIVE: Our objective is to determine whether group visits with added behavioral activation (BA) for depression (cases) will have a greater clinical impact than our standard group visits without BA for depression (active control) in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.
RESEARCH PLAN/METHODS: The goal is to conduct a randomized-controlled pilot trial (n=25 in each arm) to evaluate the clinical effect of added BA to our group intervention in patients with DM and depression who have a Hemoglobin A1c>=8% and a PHQ-9 depression score >=10 and at least one additional CVD risk factor such as tobacco use, hyperlipidemia or hypertension not at American Heart Association and American Diabetes Association guideline recommended goals. The interventions in both arms will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.
The primary aims are:
- 1) To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 6 months
- 2) To examine the acceptability and adherence to our group visit model with and without added BA therapy by way of focus groups and attendance
The secondary aim is
- 1) To explore mediating factors of our group visit model with added BA therapy that are associated with improvement in CVD risk and depression
- Conditions
- Diabetes, Depression
- Being tested
- Behavioral activation (BA)
- Keywords
- Diabetes, Depression, Group
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activation (BA)Behavioural
Also called BA MEDIC
The addition of Behavioral activation (BA) to our group visits in patients with DM and depression will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.
| Study group | Role | What they receive |
|---|---|---|
| Group visits with behavioral activation | Experimental | Group visits with behavioral activation (BA) will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse. Receives: Behavioral: Behavioral activation (BA) |
| Standard group visits | No intervention | Standard group visits will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-year UKPDS coronary event risk and PHQ-9 depression scores.
To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 6 months.
Measured: Change from baseline in 10-year UKPDS coronary event risk and PHQ-9 depression scores at 6 months..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study start19 Jan 2012
- Primary completion2 Oct 2015
- Study completion2 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Tracey H. Taveira, Providence VA Medical Center
- Investigators
- Tracey H Taveira, Pharm.D., Principal investigator, Providence VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027259
- Sponsor's protocol ID
- 12CRP9840018
- Acronym
- BA-MEDIC
- Status last verified
- Oct 2021
- First submitted
- 12 Nov 2013
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits
- ClinicalTrials.gov ID
- NCT02027259
- Acronym / sponsor ID
- BA-MEDIC / 12CRP9840018
- Conditions
- Diabetes, Depression
- Keywords
- Diabetes, Depression, Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Study start
- 19 Jan 2012 (actual)
- Primary completion
- 2 Oct 2015 (actual)
- Study completion
- 2 Oct 2015 (actual)
- First posted
- 6 Jan 2014 (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 determine whether group visits with added behavioral activation (BA) for depression will have a greater clinical impact than our standard group visits without BA for depression in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.
Detailed description
BACKGROUND Nearly 33% of the 24.5 million people in the US with diabetes mellitus (DM) have co-morbid depression. Since 65% of patients with DM die from cardiovascular disease (CVD), concomitant control of CVD risk factors along with glycemic control is crucial to prevent adverse outcomes. However, co-morbid depression makes DM and CVD risk factors harder to control. We demonstrated that a pharmacist-led group visit model consisting of: 1) pharmacotherapy management for DM, hyperlipidemia and hypertension, 2) self-management education, 3) case management and 4) behavioral strategies for DM and CVD self-care behaviors, was more efficacious in improving hyperglycemia and CVD risk factors compared to standard primary care controls in a general DM population and also for patients with DM and co-morbid depression. For participants with DM and depression there was also a non-significant trend toward improvement in depression despite the lack of depression treatment.
OBJECTIVE: Our objective is to determine whether group visits with added behavioral activation (BA) for depression (cases) will have a greater clinical impact than our standard group visits without BA for depression (active control) in reducing the risk of future coronary events as measured by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine and depression symptoms as measured by Patient Health Questionnaire-9 (PHQ-9) after 6 months.
RESEARCH PLAN/METHODS: The goal is to conduct a randomized-controlled pilot trial (n=25 in each arm) to evaluate the clinical effect of added BA to our group intervention in patients with DM and depression who have a Hemoglobin A1c>=8% and a PHQ-9 depression score >=10 and at least one additional CVD risk factor such as tobacco use, hyperlipidemia or hypertension not at American Heart Association and American Diabetes Association guideline recommended goals. The interventions in both arms will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.
The primary aims are:
- 1) To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 6 months
- 2) To examine the acceptability and adherence to our group visit model with and without added BA therapy by way of focus groups and attendance
The secondary aim is
- 1) To explore mediating factors of our group visit model with added BA therapy that are associated with improvement in CVD risk and depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group visits with behavioral activation | Experimental | Behavioral: Behavioral activation (BA)Group visits with behavioral activation (BA) will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse. |
| Standard group visits | No intervention | –Standard group visits will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of type 2 diabetes
- Clinical diagnosis of depression
- PHQ-9 score ≥10 for depressive symptoms
- >= 18 years old
- a most recent HbA1c ≥8.0% within the previous 12 months in the chart; and
Key exclusion criteria (7 listed)
- Inability to attend the group sessions
- active psychosis of any type or organic brain injury that precludes DM self- care
- type 1 diabetes as documented in the medical chart
- pregnancy
- actively suicidal and /or
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)Also: BA MEDICThe addition of Behavioral activation (BA) to our group visits in patients with DM and depression will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse. | Behavioural | Group visits with behavioral activation |
Primary outcome
Change in 10-year UKPDS coronary event risk and PHQ-9 depression scores.
Time frame: Change from baseline in 10-year UKPDS coronary event risk and PHQ-9 depression scores at 6 months..
To examine the effects of our group visit model with and without added BA therapy on the 10-year UKPDS coronary event risk, and PHQ-9 depression scores after 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 15 Oct 2021.
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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.
Tracey H Taveira, Pharm.D. principal investigator
Providence VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral activation (BA) in people with Diabetes and Depression, run by Providence VA Medical Center 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 9 inclusion and 7 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 15 Oct 2021. 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?
Change in 10-year UKPDS coronary event risk and PHQ-9 depression scores. (time frame: Change from baseline in 10-year UKPDS coronary event risk and PHQ-9 depression scores at 6 months..). 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 15 Oct 2021.