Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients

NCT01630512 | Completed

• 1 other identifier: METIS
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• change in severity of depressive symptoms

  severity of depressive symptoms will be assessed with the Beck Depression Inventory-II

  change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months

Secondary Outcomes (6)

• change in diabetes related distress

  change from baseline in diabetes related distress at 3 months, 6 months, and 12 months

• change in generalized anxiety

  change from baseline in generalized anxiety at 3 months, 6 months, and 12 months

• change in well-being

  change from baseline in well-being at 3 months, 6 months, and 12 months

• change in depressive symptoms

  change from baseline in depressive symptoms at 3 months, 6 months, and 12 months

• change in glycemic control

  change from baseline in glycemic control at post-treatment

Study Arms (3)

MBCT

EXPERIMENTAL

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

CBT

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy (CBT)

Waitlist

NO INTERVENTION

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) BEHAVIORAL

The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.

MBCT

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.

CBT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Groningen: collaborator

Study Sites (1)

UMCG

Groningen, 9713 AV, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25566369 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robbert Sanderman, Prof. dr.

  University Medical Center Groningen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 28, 2012
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

NL (1)