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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01498614
Enrollment
321
Registered
2011-12-23
Start date
2009-03-31
Completion date
2018-11-28
Last updated
2018-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alexithymia, Anxiety, Depression, Diabetes Mellitus

Keywords

Diabetes mellitus, depression, anxiety, negative self image, alexithymia, metabolic control, diabetes complications

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.

Interventions

BEHAVIORALAffect School and Basal body awareness

Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method

Sponsors

Landstinget Kronoberg, Sweden
CollaboratorUNKNOWN
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of depression3 yearsEvaluate depression score before and after intervention

Secondary

MeasureTime frameDescription
Level of A1C3 yearsCompare the A1C level before and after intervention

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026