Clinical trial NCT01870141: Psychological Distress and Type 2 Diabetes
Official title: Glycaemic Control, Body Weight and Psychological Distress in Type 2 Diabetes: The Role of Self-Efficacy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Type 2 Diabetes
Psychological Distress
Keywords: Glucose Control
Depression
Self-Efficacy
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 61
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. Standard diabetes care
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.

Secondary outcomes: reduction of depression and anxiety, improvement in self-efficacy, perceived interference caused by diabetes, family support and eating problems.

Detailed description: Several studies have reported higher level of psychological disorders in people with diabetes such as depression and anxiety. A recent meta-analysis suggests that the odds of depression in the diabetic patients is twice than in nondiabetic subjects and this difference persists even after adjustment for sex, type of diabetes or assessment method. Furthermore, depression is significantly associated with hyperglycemia. Several proposals exist to explain this association.

The aim of this project is to study the effect of a psychological intervention based on cognitive-behavioural strategies in patients with type II diabetes. The effect will be evaluate on both physiological and psychosocial parameters. The hypothesis is that a psychological intervention based on cognitive behavioural strategies increases patient's belief in his self-efficacy to succeed in diabetes care. The improvement in self-efficacy will therefore lead to improve the psychological status, i.e. depression.

Material and Methods: The investigators will perform a randomized controlled trial (RCT). A sample of 80 type 2 diabetic patients will be recruited at Endocrinology Unit of Verona Hospital during routine medical examination and then randomly assigned to intervention or control arm. In details, patients will be first recruited for participation in the study by their physician. Thereafter, patients will be approached by psychologist who will explain research and its goals. Control group will receive current standard of diabetes care. Intervention group will receive a weekly psychological intervention based on cognitive behavioural strategies. Each session will be based on self-monitoring, problem solving and goal setting. The first session will be held two weeks after the enrollment and the last one will take place at twenty-sixth week. Subjects will be given a food and physical activity diary as well as a pedometer. Study participants will weekly fill in the diary starting from 2nd session until the 19th session for a total of 18 weeks. Subjects will carry the pedometer for the same time window.

The psychological intervention comprises three phases:

PHASE 1 (1°-2° session):

* Psychological testing
* Therapeutic alliance formation
* Goal definition

PHASE 2 (3°-19°)

* Food and physical activity self-monitoring
* Identifying unhealthy behaviours and helping subject to change them
* Identifying negative beliefs and replace them with positive and healthy ones
* Providing coping strategies to stress and emotions

PHASE 3 (20°-24°)

* Reinforcing behaviour modification
* Identifying possible barriers
* Activation of personal and social resources

Outcome measures will be assessed at baseline (pre-treatment), after 26 weeks treatment (post-treatment) and at 38 weeks follow up (follow-up).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline glycosylated haemoglobin (HbA1c) at 26th and 38th weeks [mmol/mol]
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)
Secondary outcomes:
measure: Change from baseline Body Mass Index (BMI)at 26th and 38th weeks [Kg/m2]
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
measure: Change from baseline depressive symptoms at 26th and 38th weeks (BDI-II score)
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
measure: Change from baseline anxiety symptoms at 26th and 38th weeks(BAI score)
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
measure: Change from baseline general perceptions of diabetes at 26th and 38th weeks (MDQ Section 1 score)
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
measure: Change from baseline family support at 26th and 38th weeks (MDQ section II score)
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
measure: Change from baseline Diabetes Self-Efficacy at 26th and 38th weeks (MDQ section III score)
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
measure: Change from baseline Binge-Eating Disorders at 26th and 38th weeks (BES score)
timeFrame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Division of Endocrinology and Metabolic Diseases
Study officials:
affiliation: Universita di Verona
name: Enzo Bonora, MD
role: PRINCIPAL_INVESTIGATOR
References: