Clinical trial NCT01498614: Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
Official title: Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Depression
Alexithymia
Anxiety
Keywords: Diabetes mellitus
depression
anxiety
negative self image
alexithymia
metabolic control
diabetes complications
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Landstinget Kronoberg, Sweden
First posted: 2011-12-23
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness

Background:

Depression is common in patients with diabetes and is associated with impaired metabolic control. 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 (BBA) is a stress-reducing technique.

Purpose:

Our aim is to: 1. Analyze the prevalence of depression and anxiety and the personality variables alexithymia and self image in diabetes patients. 2. Explore correlations between these variables and risk factors, including biochemical markers for diabetic complications. 3. To evaluate an intervention with AS and BBA 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 of 350 people with 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 A1c ≥ 8 and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image (SASB: AFF \<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: 9 group meetings and 6 individual sessions with a physiotherapist as instructor. Post intervention: Self report tests, A1c, cytokines, hormones, cortisol.


Eligibility criteria: Inclusion Criteria:

* Type 1 and type 2 diabetes at a specialist outpatient clinic in Vaxjo

Exclusion Criteria:

* Other severe somatic disorder, including being deaf or blind.
* Severe psychiatric disorder requiring psychiatric specialist care;
* psychotic disorder,
* bipolar disorder,
* severe drug abuse.
* Inadequate knowledge of Swedish.

Primary outcomes:
measure: Prevalence of depression
timeFrame: 3 years
Secondary outcomes:
measure: Level of A1C
timeFrame: 3 years
Other outcomes:
Locations:
city: Vaxjo
country: Sweden
facility: Landstinget Kronoberg
state: Kronoberg
Study officials:
affiliation: Landstinget Kronoberg, Sweden
name: Eva O Melin, MD
role: PRINCIPAL_INVESTIGATOR
References: