Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness

Lund University

Status: Terminated

Conditions: Alexithymia; Diabetes Mellitus; Depression; Anxiety

Treatments: Behavioral: Affect School and Basal body awareness

Study type: Interventional

Funder types: Other

Identifiers

NCT01498614

FoU-Kronoberg Sweden 4522

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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321 participants in 2 patient groups

Affect school

Experimental group

Description:

Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist

Treatment:

Behavioral: Affect School and Basal body awareness

Basal body awareness

Active Comparator group

Description:

Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings

Treatment:

Behavioral: Affect School and Basal body awareness