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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Affect School
Psychological group education intervention
|
|
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Active Comparator: Body Awareness Therapy
Physiotherapeutic psychosomatic intervention
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
Aikaikkuna: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Level of HbA1c
Aikaikkuna: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Compare the HbA1c level before and after intervention
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
|
Alexithymia
Aikaikkuna: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
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
|
|
Anxiety
Aikaikkuna: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
|
Self-image
Aikaikkuna: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
|
First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Eva O Melin, MD, Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- FoU-Kronoberg 4522
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