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

NCT01498614 | Terminated

• 1 other identifier: FoU-Kronoberg Sweden 4522
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of depression

  Evaluate depression score before and after intervention

  3 years

Secondary Outcomes (1)

• Level of A1C

  3 years

Study Arms (2)

Affect school

EXPERIMENTAL

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

Basal body awareness

ACTIVE COMPARATOR

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

Behavioral: Affect School and Basal body awareness

Interventions

Affect School and Basal body awareness BEHAVIORAL

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

Affect school; Basal body awareness

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 and type 2 diabetes at a specialist outpatient clinic in Vaxjo

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead
• Landstinget Kronoberg, Sweden: collaborator

Study Sites (1)

Landstinget Kronoberg

Vaxjo, Kronoberg County, s-35251, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Depression; Affective Symptoms; Anxiety Disorders; Diabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Eva O Melin, MD

  Landstinget Kronoberg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: March 1, 2009
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

SE (1)