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

NCT ID: NCT01498614

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2018-11-28

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.

Conditions

Diabetes Mellitus; Depression; Alexithymia; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Affect school

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

Group Type: EXPERIMENTAL

Affect School and Basal body awareness

Intervention Type: BEHAVIORAL

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

Basal body awareness

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

Group Type: ACTIVE_COMPARATOR

Affect School and Basal body awareness

Intervention Type: BEHAVIORAL

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

Interventions

Affect 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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Landstinget Kronoberg, Sweden

UNKNOWN

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva O Melin, MD

Role: PRINCIPAL_INVESTIGATOR

Landstinget Kronoberg, Sweden

Locations

Landstinget Kronoberg

Vaxjo, Kronoberg County, Sweden

Countries

Sweden

Other Identifiers

FoU-Kronoberg Sweden 4522

Identifier Type: -

Identifier Source: org_study_id