Psychological Distress and Type 2 Diabetes (COPEST)

Experimental: Psychological Intervention

Cognitive Behavioural Intervention

Conductual: Cognitive-Behavioral Intervention

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

Sin intervención: Current standard of care

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).

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

Body Mass Index is a measure of adiposity and is used here as anthropometric marker of life style change.

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

The Beck Depression Inventory II is a 21-item questionnaire developed to assess the intensity of depression as defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV). The BDI-II items include (1) cognitive symptoms such as sadness and pessimism, (2) affective symptoms such as loss of pleasure and loss of interest, (3) somatic symptoms such as loss of energy, appetite changes and changes in sleep pattern.

The BDI-II is calculated by summing the ratings for the 21 items. The 4-point scale ranges from 0 to 3 for each item. The maximum total score is 63.

The measurement of outcome variables will be conducted 38 weeks after termination of the treatment (38 weeks follow up). The difference of the BDI-II scores among baseline (pretreatment), at the end of the 26 weeks treatment (post-treatment), and at 38 weeks follow up (follow-up) will be also calculated.

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

The Beck Anxiety Inventory is a 21- item questionnaire developed to assess the severity of an anxiety in adult and adolescents. The items in the BAI describe the emotional, physiological and cognitive symptoms of anxiety.

The 4-point scale ranges from 0 to 3 for each item. The maximum total score is 63.

The decisive measurement of the outcome variables will be conducted 38 weeks after termination of the treatment (38 weeks follow up). The difference of the BDI-II scores among baseline (pretreatment), at the end of the 26 weeks treatment (post-treatment), and at 38 weeks follow up (follow-up) will be also calculated.

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

The Multidimensional Diabetes Questionnaire (MDQ) was designed to provide a comprehensive assessment of diabetes-related cognitive and social factors. It includes 41 items subcategorized in three sections. The first section assesses the general perceptions of diabetes and related social support. It is comprised of three scales. These scales targets:

1. perceived interference caused by diabetes to daily activities, work and social activities (9 items);
2. perceived severity of diabetes ( 3 items);
3. perceived diabetes-related social support from a significant other such as family, friends and health professionals (4 items).

Responses were rated on 7-point rating scales (from 0 to 6), with higher scores indicating higher levels of perceived interference, social support and severity.

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

This section of the MDQ measures social incentives in relation to self-care activities. The scales included in this section were designed to measure the frequency of positive reinforcing behaviour (8 items) and the frequency of non supportive behaviours (4 items). Subjects recorded their responses on 7-point Likert scales (from 0 to 6) with higher scores indicating higher levels of positive and negative reinforcement behaviours.

Change from baseline Diabetes Self-Efficacy at 26th and 38th weeks (MDQ section III score)

This section of the MDQ is used to assess self-efficacy expectancies (7 items) and outcome expectancies (6 items). The self-efficacy scale measured patients' confidence in their ability to perform behaviours specific to the diabetes self-care activities. Responses were rated on a 0 to 100 rating scale. The outcome expectancies scale assessed patients' perceptions of the effect of diabetes self-care behaviours on metabolic control. Responses were rated on a 0 to 100 rating scale.

Change from baseline Binge-Eating Disorders at 26th and 38th weeks (BES score)

The Binge-Eating Scale (BES) is a 16-item questionnaire developed to assess the presence of binge eating behaviour indicative of eating disorders. The BES includes questions on subjects' concerns about weight and food, inability to control urges to eat, feelings of guilt after eating and frequency of strict dieting.

Each question has 3-4 separate responses assigned a numerical value. The score ranges is from 0-46