Psychological Distress and Type 2 Diabetes (COPEST)
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:
- 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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Verona、イタリア、37126
- Division of Endocrinology and Metabolic Diseases
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Psychological Intervention
Cognitive Behavioural Intervention
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1 weekly individual 45 min-session for 24 weeks. The program comprises the following cognitive-behavioral strategies:
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介入なし：Current standard of care
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline glycosylated haemoglobin (HbA1c) at 26th and 38th weeks [mmol/mol]
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)
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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).
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Baseline, 26 weeks (post-treatment)-38 weeks (FU)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline Body Mass Index (BMI)at 26th and 38th weeks [Kg/m2]
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Body Mass Index is a measure of adiposity and is used here as anthropometric marker of life style change.
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Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Change from baseline depressive symptoms at 26th and 38th weeks (BDI-II score)
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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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. |
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Change from baseline anxiety symptoms at 26th and 38th weeks(BAI score)
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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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. |
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Change from baseline general perceptions of diabetes at 26th and 38th weeks (MDQ Section 1 score)
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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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:
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. |
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Change from baseline family support at 26th and 38th weeks (MDQ section II score)
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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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.
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Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Change from baseline Diabetes Self-Efficacy at 26th and 38th weeks (MDQ section III score)
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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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.
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Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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Change from baseline Binge-Eating Disorders at 26th and 38th weeks (BES score)
時間枠：Baseline, 26 weeks (post-treatment)-38 weeks (FU)
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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 |
Baseline, 26 weeks (post-treatment)-38 weeks (FU)
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協力者と研究者
捜査官
- 主任研究者：Enzo Bonora, MD、Universita di Verona
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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