NCT01870141

Brief Summary

Increasing evidence suggests that psychological disorders play an important role in the development and worsening of type 2 diabetes (T2D). Among the spectrum of psychological disorders, there is a wide literature about the association between depression and T2D and current data show an approximately two-fold prevalence of depression in adults affected by diabetes compared to un-affected subjects. Moreover, depression in diabetic patients is associated with higher blood glucose levels, poorer adherence to therapeutic regimens (whether pharmacological or therapeutic lifestyle changes), more medical complications, and higher hospitalization rates. Nevertheless, at the best of our knowledge, the mechanism underlying the association between depression and adverse diabetes-related outcomes is currently unresolved. Aim of this project is to assess the efficacy of a psychological treatment for diabetic patients with suboptimal level of Hemoglobin A1c. This project is a RCT that seeks to address the question if type 2 diabetic patients with suboptimal glycaemic control would benefit from a specific psychological intervention, as specified below. A total of 80 diabetic patients will be recruited and randomly assigned to two treatment arms:

  1. 1.Standard diabetes care
  2. 2.24 individual sessions of psychological intervention The expected main outcome is the improvement of glycaemic control under psychological intervention in 38 weeks of follow up.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
61

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

April 19, 2013

Last Update Submit

January 17, 2020

Conditions

Type 2 DiabetesPsychological Distress

Keywords

Glucose ControlDepressionSelf-Efficacy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline glycosylated haemoglobin (HbA1c) at 26th and 38th weeks [mmol/mol]

    Glycosylated haemoglobin (HbA1c) is a lab test that shows the average level of blood glucose over the previous 3 months. HbA1c is used in the present study as measure of the glycaemic control: it will be assessed at baseline (pre-treatment), after 26 weeks treatment (post-treatment) and at 38 weeks follow up (follow-up).

    Baseline, 26 weeks (post-treatment)-38 weeks (FU)

Secondary Outcomes (7)

  • Change from baseline Body Mass Index (BMI)at 26th and 38th weeks [Kg/m2]

    Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

  • Change from baseline depressive symptoms at 26th and 38th weeks (BDI-II score)

    Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

  • Change from baseline anxiety symptoms at 26th and 38th weeks(BAI score)

    Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

  • Change from baseline general perceptions of diabetes at 26th and 38th weeks (MDQ Section 1 score)

    Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

  • Change from baseline family support at 26th and 38th weeks (MDQ section II score)

    Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

  • +2 more secondary outcomes

Study Arms (2)

Psychological Intervention

EXPERIMENTAL

Cognitive Behavioural Intervention

Behavioral: Cognitive-Behavioral Intervention

Current standard of care

NO INTERVENTION

Interventions

Cognitive-Behavioral InterventionBEHAVIORAL

1 weekly individual 45 min-session for 24 weeks. The program comprises the following cognitive-behavioral strategies: * self-monitoring * problem solving * goal definition * cognitive restructuring * activation of personal and social resources

Psychological Intervention

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes diagnosed at least 1 year before enrollment
  • ≤ BMI ≤ 40 Kg⋅m-2
  • to 75 years
  • HbA1c \> 7,0%

You may not qualify if:

  • Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
  • Current psychotherapy
  • Severe physical illness (i.e. cancer)
  • Pregnancy
  • Eligibility to bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology and Metabolic Diseases

Verona, 37126, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Depression

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Enzo Bonora, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

June 5, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2015

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

IT(1)