Depressive SymptomsNCT01630512
Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) in people with Depressive Symptoms, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to May 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus Type 1 or 2 for at least three months prior to inclusion
- Written informed consent
- Age ≥ 18 and ≤ 70
- Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)
Who cannot join
- Not being able to read and write Dutch
- Severe (psychiatric) co-morbidity
- Acute suicidal ideations or behavior
- Pregnancy
- Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study
- Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial
The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in patients with diabetes.
Read the detailed description
Depression is a common co-morbidity of diabetes, negatively affecting physical performance, glycemic control, adherence to medication, and dietary, and exercise recommendations. Modalities of psychotherapy like cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) can reduce depressive symptoms in patients with medical conditions. However, proper designed randomized trials assessing and comparing effectiveness of these psychological interventions are rare.
This longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in diabetes patients. Furthermore, potential moderators and mediators of treatment effect will be explored, as well as the role of common factors and treatment integrity.
- Conditions
- Depressive Symptoms
- Being tested
- Mindfulness-Based Cognitive Therapy (MBCT), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
Cognitive Behavioral Therapy (CBT)Behavioural
The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| MBCT | Experimental | Not described Receives: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
| CBT | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in severity of depressive symptoms
severity of depressive symptoms will be assessed with the Beck Depression Inventory-II
Measured: change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months
Secondary outcomes (6)
change in diabetes related distress
diabetes related distress will be measured by the Problem Areas in Diabetes scale (PAID)
Measured: change from baseline in diabetes related distress at 3 months, 6 months, and 12 months
change in generalized anxiety
generalized anxiety will be measured by the Generalised Anxiety Disorder Assessment (GAD 7)
Measured: change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
change in well-being
well-being will be measured by the Well-being Index (WHO-5)
Measured: change from baseline in well-being at 3 months, 6 months, and 12 months
change in depressive symptoms
depressive symptoms will be measured by the 7-Item Hamilton Depression Rating scale (HAM-D7)
Measured: change from baseline in depressive symptoms at 3 months, 6 months, and 12 months
change in glycemic control
glycemic control will be indicated with HbA1c values
Measured: change from baseline in glycemic control at post-treatment
intersession changes in mood
intersession changes in mood will be assessed by the Emotion Thermometers Tool (ETT)
Measured: change in mood from the beginning of the first session to the beginning of the last session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Sponsor
- Investigators
- Robbert Sanderman, Prof. dr., Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630512
- Sponsor's protocol ID
- METIS
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2012
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Tovote KA, Fleer J, Snippe E, Bas IV, Links TP, Emmelkamp PM, Sanderman R, Schroevers MJ. Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial. BMC Psychol. 2013 Oct 9;1(1):17. doi: 10.1186/2050-7283-1-17. eCollection 2013.
PubMed 25566369
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Patients With Diabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01630512
- Acronym / sponsor ID
- METIS
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- First posted
- 28 Jun 2012 (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 mindfulness-based cognitive therapy (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in patients with diabetes.
Detailed description
Depression is a common co-morbidity of diabetes, negatively affecting physical performance, glycemic control, adherence to medication, and dietary, and exercise recommendations. Modalities of psychotherapy like cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) can reduce depressive symptoms in patients with medical conditions. However, proper designed randomized trials assessing and comparing effectiveness of these psychological interventions are rare.
This longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in diabetes patients. Furthermore, potential moderators and mediators of treatment effect will be explored, as well as the role of common factors and treatment integrity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBCT | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
| CBT | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT) |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes mellitus Type 1 or 2 for at least three months prior to inclusion
- Written informed consent
- Age ≥ 18 and ≤ 70
- Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)
Key exclusion criteria (6 listed)
- Not being able to read and write Dutch
- Severe (psychiatric) co-morbidity
- Acute suicidal ideations or behavior
- Pregnancy
- Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study
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 |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT)The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes. | Behavioural | MBCT |
| Cognitive Behavioral Therapy (CBT)The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes. | Behavioural | CBT |
Primary outcome
change in severity of depressive symptoms
Time frame: change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months
severity of depressive symptoms will be assessed with the Beck Depression Inventory-II
6 secondary outcomes
change in diabetes related distress
Time frame: change from baseline in diabetes related distress at 3 months, 6 months, and 12 months
change in generalized anxiety
Time frame: change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
change in well-being
Time frame: change from baseline in well-being at 3 months, 6 months, and 12 months
change in depressive symptoms
Time frame: change from baseline in depressive symptoms at 3 months, 6 months, and 12 months
change in glycemic control
Time frame: change from baseline in glycemic control at post-treatment
intersession changes in mood
Time frame: change in mood from the beginning of the first session to the beginning of the last session
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 18 Apr 2024.
- Derived from this study: PubMed 25566369Tovote KA, Fleer J, Snippe E, Bas IV, Links TP, Emmelkamp PM, Sanderman R, Schroevers MJ. Cognitive behavioral therapy and mindfulness-based cognitive therapy for depressive symptoms in patients with diabetes: design of a randomized controlled trial. BMC Psychol. 2013 Oct 9;1(1):17. doi: 10.1186/2050-7283-1-17. eCollection 2013.
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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.
Robbert Sanderman, Prof. dr. study chair
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) in people with Depressive Symptoms, run by University Medical Center Groningen at 1 site in Netherlands.
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 6 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 18 Apr 2024. 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 Netherlands. 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 severity of depressive symptoms (time frame: change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 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 NCT01630512, 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 18 Apr 2024.