NCT01714986

Brief Summary

The investigators want to try the psycho educational method "The Affect School with Script Analysis and the physiotherapeutic mind-body therapy "Basal Body Awareness Therapy in patients with diabetes, high HbA1c and psychological symptoms, in order to improve psychological health- with the primary outcome reduced depression. Secondary outcomes are improved improved glycemic control and self-image, and reduced alexithymia and anxiety.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable diabetes-mellitus

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

14.8 years

First QC Date

October 24, 2012

Last Update Submit

December 19, 2018

Conditions

Diabetes MellitusDepressionAlexithymiaAnxiety

Keywords

Diabetes mellitusDepressionAnxietyAlexithymiaSelf ImageHbA1cPsychoeducation

Outcome Measures

Primary Outcomes (1)

  • Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c

    a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy

    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline

Secondary Outcomes (4)

  • Level of HbA1c

    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline

  • Alexithymia

    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline

  • Anxiety

    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline

  • Self-image

    First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline

Study Arms (2)

Affect School

ACTIVE COMPARATOR

Psychological group education intervention

Behavioral: Affect School

Body Awareness Therapy

ACTIVE COMPARATOR

Physiotherapeutic psychosomatic intervention

Behavioral: Body Awareness Therapy

Interventions

Affect SchoolBEHAVIORAL
Affect School
Body Awareness TherapyBEHAVIORAL
Body Awareness Therapy

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 or type 2 diabetes and diabetes duration ≥1 year and HbA1c \>70 mmol/mol, and one of the following: depression, alexithymia, anxiety or a negative self image.

You may not qualify if:

  • 1) pregnancy; 2) severe comorbidities if it is anticipated that participation will be difficult or unsafe for the patient (end-stage renal disease, cancer, hepatic failure, deafness, social blindness, psychotic disorder, bipolar disorder, suicide ideation, severe personality disorder or severe substance abuse), 3) cognitive deficiencies (mental retardation, stroke or dementia); or 5) inadequate Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Melin EO, Svensson R, Gustavsson SA, Winberg A, Denward-Olah E, Landin-Olsson M, Thulesius HO. Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials. Trials. 2016 Apr 27;17(1):221. doi: 10.1186/s13063-016-1347-8.

    PMID: 27121185DERIVED

MeSH Terms

Conditions

Diabetes MellitusDepressionAffective SymptomsAnxiety Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Eva O Melin, MD

    Fou Kronoberg, Kronoberg County Council, Växjö, Sweden

    PRINCIPAL INVESTIGATOR
0

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

October 24, 2012

First Posted

October 26, 2012

Study Start

March 1, 2009

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

December 21, 2018

Record last verified: 2018-12