Type 2 DiabetesCOPESTNCT01870141
Psychological Distress and Type 2 Diabetes
A study testing Cognitive-Behavioral Intervention in people with Type 2 Diabetes and Psychological Distress, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Psychological Distress
- What is being tested?
- Cognitive-Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2012to Mar 2015
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes diagnosed at least 1 year before enrollment
- 25 ≤ BMI ≤ 40 Kg⋅m-2
- 25 to 75 years
- HbA1c > 7,0%
Who cannot join
- Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
- Current psychotherapy
- Severe physical illness (i.e. cancer)
- Pregnancy
- Eligibility to bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycaemic Control, Body Weight and Psychological Distress in Type 2 Diabetes: The Role of Self-Efficacy
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:
Read more
- Standard diabetes care
- 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.
Read the 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).
- Conditions
- Type 2 Diabetes, Psychological Distress
- Being tested
- Cognitive-Behavioral Intervention
- Keywords
- Glucose Control, Depression, Self-Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | Cognitive Behavioural Intervention Receives: Behavioral: Cognitive-Behavioral Intervention |
| Current standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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]
Body Mass Index is a measure of adiposity and is used here as anthropometric marker of life style change.
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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.
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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.
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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:
- perceived interference caused by diabetes to daily activities, work and social activities (9 items);
- perceived severity of diabetes ( 3 items);
- 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.
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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.
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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.
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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
Measured: Baseline, 26 weeks (post-treatment)-38 weeks (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2015
Why it stopped: Study halted prematurely but potentially will resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enzo Bonora, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870141
- Sponsor's protocol ID
- CE-2212 Ago, 29 2012
- Acronym
- COPEST
- Status last verified
- Jan 2020
- First submitted
- 19 Apr 2013
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Control, Body Weight and Psychological Distress in Type 2 Diabetes: The Role of Self-Efficacy
- ClinicalTrials.gov ID
- NCT01870141
- Acronym / sponsor ID
- COPEST / CE-2212 Ago, 29 2012
- Conditions
- Type 2 Diabetes, Psychological Distress
- Keywords
- Glucose Control, Depression, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study halted prematurely but potentially will resume
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Mar 2015 (actual)
- First posted
- 5 Jun 2013 (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.
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:
- Standard diabetes care
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Cognitive-Behavioral InterventionCognitive Behavioural Intervention |
| Current standard of care | No intervention | – |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes diagnosed at least 1 year before enrollment
- 25 ≤ BMI ≤ 40 Kg⋅m-2
- 25 to 75 years
- HbA1c > 7,0%
Key exclusion criteria (5 listed)
- Current schizophrenia/ psychotic disorders, bipolar disorders, addictive disorders, personality disorders
- Current psychotherapy
- Severe physical illness (i.e. cancer)
- Pregnancy
- Eligibility to bariatric surgery
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 |
|---|---|---|
| Cognitive-Behavioral Intervention1 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 | Behavioural | Psychological Intervention |
Primary outcome
Change from baseline glycosylated haemoglobin (HbA1c) at 26th and 38th weeks [mmol/mol]
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)
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).
7 secondary outcomes
Change from baseline Body Mass Index (BMI)at 26th and 38th weeks [Kg/m2]
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline depressive symptoms at 26th and 38th weeks (BDI-II score)
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline anxiety symptoms at 26th and 38th weeks(BAI score)
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline general perceptions of diabetes at 26th and 38th weeks (MDQ Section 1 score)
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline family support at 26th and 38th weeks (MDQ section II score)
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline Diabetes Self-Efficacy at 26th and 38th weeks (MDQ section III score)
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline Binge-Eating Disorders at 26th and 38th weeks (BES score)
Time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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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.
Enzo Bonora, MD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Intervention in people with Type 2 Diabetes and Psychological Distress, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 5 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: paused, as of the sponsor's last update on 22 Jan 2020. 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 Italy. 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?
Results are not available in the source record.
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 from baseline glycosylated haemoglobin (HbA1c) at 26th and 38th weeks [mmol/mol] (time frame: Baseline, 26 weeks (post-treatment)-38 weeks (FU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.