Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Lund University
- Enrollment
- 321
- Locations
- 2
- Primary Endpoint
- Prevalence of depression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Affect school
Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist
Intervention: Affect School and Basal body awareness (Behavioral)
Basal body awareness
Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings
Intervention: Affect School and Basal body awareness (Behavioral)
Outcomes
Primary Outcomes
Prevalence of depression
Time Frame: 3 years
Evaluate depression score before and after intervention
Secondary Outcomes
- Level of A1C(3 years)