Diabetes MellitusNCT00564070

CBT for Adherence and Depression in Diabetes

A study testing Enhanced treatment as usual plus adherence training and Enhanced treatment as usual plus CBT-AD in people with Diabetes Mellitus and Depression, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Depression
What is being tested?: Enhanced treatment as usual plus adherence training and Enhanced treatment as usual plus CBT-AD
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Mar 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of type 2 diabetes that is poorly controlled despite treatment with an oral hypoglycemic, insulin, or both
Diagnosis of major depression or dysthymia, or current subclinical symptoms of depression in spite of prescription of an antidepressant
If on an antidepressant, oral hypoglycemic medication, or insulin, must have been on a stable dose for the preceding two months

Who cannot join

Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia
Experiencing suicidal thoughts
History of or currently receiving CBT for depression
Uses an insulin pump

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

This study will evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.

Read the detailed description

Depression is a serious illness that affects a person's mood, thoughts, and physical being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression is highly comorbid, often occurring in the presence of one or more other disorders. Up to 15% to 20% of the time, people with diabetes are also depressed. Diabetes is a disease that interferes with the body's proper production and use of the hormone insulin, which is needed to convert food into the energy required to perform daily life activities. Self-care is a crucial component of diabetes treatment. However, symptoms of depression can interfere with behaviors necessary to carry out this care. Cognitive behavioral therapy (CBT) has shown success in treating people with depression, but the effect of CBT on self-care behaviors and depression of those with diabetes is not well known. This study will evaluate the effectiveness of CBT for medical adherence and depression (CBT-AD) in people with a depressive mood disorder and type 2 diabetes.

Upon study entry, all participants will complete various assessments, including a psychiatric diagnostic interview, a series of paper questionnaires, neuropsychological testing, blood sample analysis, and blood sugar monitoring. Next, all participants will meet with a nutritionist and a nurse diabetes educator. The nutritionist will help set goals for eating, physical activity, weight, and blood glucose. The nurse diabetes educator will review diabetes medication history and blood glucose self-monitoring equipment.

Participants will then be randomly placed in one of two counseling groups. One group will meet for a single session that will be devoted to diabetes medical adherence. The other group will attend 10 to12 individual CBT sessions for diabetes medical adherence and depression management. The CBT sessions will last 45 to 50 minutes and will require practice of coping skills outside the sessions. Participants receiving CBT will also complete weekly assessments of depression, self-care, and diabetes medical adherence. All participants will be asked to monitor a prescribed medication with a pill cap for the course of the study. At Month 2, participants in both groups will also meet again with the nutritionist to review original goals and adjust them as necessary. Most of the previous study assessments will be repeated at Months 4, 8, and 12. The neuropsychological testing will be repeated only at Month 12.

Conditions: Diabetes Mellitus, Depression
Being tested: Enhanced treatment as usual plus adherence training, Enhanced treatment as usual plus CBT-AD
Keywords: Depression, Diabetes, Adherence
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.

Enhanced treatment as usual plus adherence trainingBehavioural
The single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.
Enhanced treatment as usual plus CBT-ADBehavioural
The multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.

Study groups in NCT00564070
Study group	Role	What they receive
Enhanced treatment as usual	Active comparator	Enhanced treatment as usual plus single-session life-steps treatment Receives: Behavioral: Enhanced treatment as usual plus adherence training
CBT-AD	Experimental	Enhanced treatment as usual plus multiple-session CBT treatment (CBT-AD) Receives: Behavioral: Enhanced treatment as usual plus CBT-AD

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose Monitoring Adherence at Acute Outcome
Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.
Measured: Measured at Month 4
Percent Medication Adherence Via MEMS
This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence
Measured: month 4
Clinician Rated Depression (MADRS) at the Acute Timepoint
Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.
Measured: month 4
Depression on the CGI at Acute Outcome
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression
Measured: Month 4

Secondary outcomes (1)

Glucose Control
Hemoglobin A1C value at acute outcome. HbA1c is the number of hemoglobin in red blood cells that is glycosylated (attached to sugar) and is reported here as a percentage.
Measured: Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Mar 2012

First posted27 Nov 2007 (estimated)
Study startJun 2007
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00564070
Sponsor's protocol ID: R01MH078571
Other IDs: R01MH078571
Status last verified: Dec 2017
First submitted: 23 Nov 2007
Last updated: 8 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29.
PubMed 24170758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CBT for Adherence and Depression in Diabetes
ClinicalTrials.gov ID: NCT00564070
Acronym / sponsor ID: R01MH078571
Conditions: Diabetes Mellitus, Depression
Keywords: Depression, Diabetes, Adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jun 2007
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 27 Nov 2007 (estimated)
Results: Posted 8 Jan 2018

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 evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating people with depression and type 2 diabetes.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Enhanced treatment as usual	Active comparator	Behavioral: Enhanced treatment as usual plus adherence trainingEnhanced treatment as usual plus single-session life-steps treatment
CBT-AD	Experimental	Behavioral: Enhanced treatment as usual plus CBT-ADEnhanced treatment as usual plus multiple-session CBT treatment (CBT-AD)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of type 2 diabetes that is poorly controlled despite treatment with an oral hypoglycemic, insulin, or both
Diagnosis of major depression or dysthymia, or current subclinical symptoms of depression in spite of prescription of an antidepressant
If on an antidepressant, oral hypoglycemic medication, or insulin, must have been on a stable dose for the preceding two months

Key exclusion criteria (4 listed)

Active untreated major mental illness (e.g., untreated psychosis), bipolar disorder, eating disorder, mental retardation, or dementia
Experiencing suicidal thoughts
History of or currently receiving CBT for depression
Uses an insulin pump

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
Enhanced treatment as usual plus adherence trainingThe single-session life-steps treatment targets informational, problem solving, and cognitive-behavioral steps that are geared toward improving medication adherence and diabetes self-management.	Behavioural	Enhanced treatment as usual
Enhanced treatment as usual plus CBT-ADThe multiple-session CBT treatment is given after completion of the life-steps session. The CBT sessions focus on treatment of depressive symptoms as well as adherence to diabetes self-care.	Behavioural	CBT-AD

Primary outcome

Glucose Monitoring Adherence at Acute Outcome
Time frame: Measured at Month 4
Medical adherence is a percent via the electronic monitoring using glucometer. This is a percent with a possible range of 0-100, with higher scores denoting better adherence.
Percent Medication Adherence Via MEMS
Time frame: month 4
This is an electronic pill cap at the acute outcome assessment. This is a percent with a possible range of 0-100, higher scores indicating greater adherence
Clinician Rated Depression (MADRS) at the Acute Timepoint
Time frame: month 4
Depression as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). This scale has a range of 0-60 with higher scores indicating greater depression severity.
Depression on the CGI at Acute Outcome
Time frame: Month 4
Clinical Global Impression is a scale from 1-7 with greater numbers meaning more severe depression

1 secondary outcome

Glucose Control
Time frame: Month 4

Results and safety

Results posted to the registry on 8 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Treatment as Usual	42	30
CBT-AD	45	38

Primary outcome: Glucose Monitoring Adherence at Acute Outcome

Time frame: Measured at Month 4. Mean (Standard Deviation). Unit: percentage of glucose monitoring goal

Measure	Enhanced Treatment as Usual n = 42	CBT-AD n = 45
Value	49.63 (4.66)	79.79 (4.03)

Enhanced Treatment as Usual vs CBT-AD: Mean Difference (Final Values): 30.2 (95% CI 17.37 to 42.9), p <.0001, Mixed Models Analysis

Primary outcome: Percent Medication Adherence Via MEMS

Time frame: month 4. Mean (Standard Deviation). Unit: Percentage of pills taken

Measure	Enhanced Treatment as Usual n = 42	CBT-AD n = 45
Value	69.69 (3.72)	90.37 (3.48)

Enhanced Treatment as Usual vs CBT-AD: Mean Difference (Final Values): 20.7 (95% CI 10.22 to 31.14), p <0.0001, Mixed Models Analysis

Population analysed: Participants in each study arm

Primary outcome: Clinician Rated Depression (MADRS) at the Acute Timepoint

Time frame: month 4. Mean (Standard Deviation). Unit: units on a scale (MADRS)

Measure	Enhanced Treatment as Usual n = 42	CBT-AD n = 45
Value	20.66 (1.52)	14.22 (1.45)

Enhanced Treatment as Usual vs CBT-AD: Mean Difference (Final Values): 6.22 (95% CI 2.33 to 10.56), p =.002, Mixed Models Analysis

Population analysed: Participants in each arm

Primary outcome: Depression on the CGI at Acute Outcome

Time frame: Month 4. Mean (Standard Deviation). Unit: units on a scale - the CGI

Measure	Enhanced Treatment as Usual n = 42	CBT-AD n = 45
Value	3.17 (.20)	2.44 (.21)

Enhanced Treatment as Usual vs CBT-AD: Mean Difference (Final Values): .74 (95% CI .16 to 1.32), p =.01, ANCOVA

Population analysed: Participants in each study arm

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Treatment as Usual	0 of 42 (0%)	0 of 42 (0%)	Not reported
CBT-AD	0 of 45 (0%)	0 of 45 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24170758Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29.

Related trials for Diabetes Mellitus

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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 Psaros, PhD study director

Partners HealthCare

Steven Safren, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 8 Jan 2018. 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?

Yes. Results are posted in the registry (first posted 8 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glucose Monitoring Adherence at Acute Outcome (time frame: Measured at Month 4). The study lists 4 primary outcomes in all. 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 NCT00564070, which also lists 1 linked publication.

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 8 Jan 2018.