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

November 28, 2018 updated by: Lund University

Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study 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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Kronoberg
      • Vaxjo, Kronoberg, Sweden, s-35251
        • Landstinget Kronoberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Affect school
Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist
Behavioral: 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
Active Comparator: Basal body awareness
Basal body awareness is an educational method with 9 group sessions followed by 6 individual meetings
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of depression
Time Frame: 3 years
Evaluate depression score before and after intervention
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of A1C
Time Frame: 3 years
Compare the A1C level before and after intervention
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Landstinget Kronoberg, Sweden

Investigators

  • Principal Investigator: Eva O Melin, MD, Landstinget Kronoberg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FoU-Kronoberg Sweden 4522

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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