Psychological Variables and Hyperglycemia in Diabetes Mellitus (ALEXIDIAB)
Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background:
Depression is common in patients with diabetes and is associated with impaired glycemic control and elevated cortisol levels. Alexithymia has been associated with depression, anxiety, stress related disorders and diabetes mellitus. Affect School (AS) is an intervention that may reduce depression and alexithymia according to previous research. Basic Body Awareness Therapy (BBAT) is a stress-reducing technique and is used in psychiatric care in Scandinavia in order to improve psychiatric health.
Purpose:
The aims are to: 1. Analyze the prevalence of depression and anxiety and the personality variables alexithymia and self image in diabetes patients at baseline. 2. Explore correlations between these variables and risk factors, including biochemical markers for diabetic complications. 3. To evaluate an intervention with Affect School with Script Analysis and Basal Body Awareness Therapy in patients with diabetes that scored high in psychometric self-report tests and at the same time showed impaired metabolic control.
Method:
A randomized controlled trial in two steps. First step started in 2009 and consists of 350 people with diabetes, 90% with type 1 diabetes, 18-59 years, 56% men, 44% women. Base-line study: from medical records and the National Diabetes Registry - waist circumference, BMI, blood pressure, type and duration of diabetes, diabetes complications, other diseases, medications, exercise habits and smoking. Tests - A1c, blood lipids, cytokines, hormones, beta-cell antibodies, c-peptide, midnight cortisol (salivary). Self-report tests of psychological and personality variables: HAD, TAS-20, SASB. Intervention: patients with HbA1c >70 mmol/mol (A1c ≥ 8 %) and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image (SASB: Affinity dimension <284) or alexithymia (TAS-20 ≥ 61) were randomized to AS or BBA. AS: 8 group sessions followed by 10 individual sessions. Instructors were a primary care physician and a psychotherapist. BBA: 10 group meetings and 5individual sessions with a physiotherapist as instructor. Post intervention: Self report tests, A1c, cortisol.
Second step will start in 2015: Recruitment of 350 people from primary care with type 2 diabetes with high A1c and either depression, alexithymia, negative self image or anxiety. Randomization procedures and patient characteristics will be assessed in the same way as above.
Tipo di studio
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Type 1 or type 2 diabetes and diabetes duration ≥1 year and HbA1c >70 mmol/mol, and one of the following: depression, alexithymia, anxiety or a negative self image.
Exclusion Criteria:
•1) pregnancy; 2) severe comorbidities if it is anticipated that participation will be difficult or unsafe for the patient (end-stage renal disease, cancer, hepatic failure, deafness, social blindness, psychotic disorder, bipolar disorder, suicide ideation, severe personality disorder or severe substance abuse), 3) cognitive deficiencies (mental retardation, stroke or dementia); or 5) inadequate Swedish
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Affect School
Psychological group education intervention
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Comparatore attivo: Body Awareness Therapy
Physiotherapeutic psychosomatic intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
Lasso di tempo: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
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First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Level of HbA1c
Lasso di tempo: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Compare the HbA1c level before and after intervention
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First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Alexithymia
Lasso di tempo: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
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First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Anxiety
Lasso di tempo: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
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First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Self-image
Lasso di tempo: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
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First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Eva O Melin, MD, Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FoU-Kronoberg 4522
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