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Psychological Distress and Type 2 Diabetes (COPEST)

17. ledna 2020 aktualizováno: Azienda Ospedaliera Universitaria Integrata Verona

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:

  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.

Přehled studie

Postavení

Pozastaveno

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Aktuální)

61

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Itálie
      • Verona, Itálie, 37126
        • Division of Endocrinology and Metabolic Diseases

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

25 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Psychological Intervention
Cognitive Behavioural Intervention
Behaviorální: 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
Žádný zásah: Current standard of care

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline glycosylated haemoglobin (HbA1c) at 26th and 38th weeks [mmol/mol]
Časové okno: 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).
Baseline, 26 weeks (post-treatment)-38 weeks (FU)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline Body Mass Index (BMI)at 26th and 38th weeks [Kg/m2]
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Body Mass Index is a measure of adiposity and is used here as anthropometric marker of life style change.
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline depressive symptoms at 26th and 38th weeks (BDI-II score)
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

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)]
Change from baseline anxiety symptoms at 26th and 38th weeks(BAI score)
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

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)]
Change from baseline general perceptions of diabetes at 26th and 38th weeks (MDQ Section 1 score)
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]

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.
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline family support at 26th and 38th weeks (MDQ section II score)
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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.
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline Diabetes Self-Efficacy at 26th and 38th weeks (MDQ section III score)
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
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.
Baseline, 26 weeks (post-treatment)-38 weeks (FU)]
Change from baseline Binge-Eating Disorders at 26th and 38th weeks (BES score)
Časové okno: Baseline, 26 weeks (post-treatment)-38 weeks (FU)

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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Azienda Ospedaliera Universitaria Integrata Verona

Vyšetřovatelé

  • Vrchní vyšetřovatel: Enzo Bonora, MD, Universita di Verona

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. října 2012

Primární dokončení (Aktuální)

1. března 2015

Termíny zápisu do studia

První předloženo

19. dubna 2013

První předloženo, které splnilo kritéria kontroly kvality

3. června 2013

První zveřejněno (Odhad)

5. června 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. ledna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. ledna 2020

Naposledy ověřeno

1. ledna 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CE-2212 Ago, 29 2012

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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