Depression Clinical Trial
Official title:
Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
Verified date | November 2018 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 321 |
Est. completion date | November 28, 2018 |
Est. primary completion date | November 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Landstinget Kronoberg | Vaxjo | Kronoberg |
Lead Sponsor | Collaborator |
---|---|
Lund University | Landstinget Kronoberg, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of depression | Evaluate depression score before and after intervention | 3 years | |
Secondary | Level of A1C | Compare the A1C level before and after intervention | 3 years |
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