Diabetes MellitusALEXIDIABNCT01714986
Psychological Variables and Hyperglycemia in Diabetes Mellitus
A study testing Affect School and Body Awareness Therapy in people with Diabetes Mellitus and Depression, run by Lund University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Diabetes Mellitus, Depression, Alexithymia
- What is being tested?
- Affect School and Body Awareness Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- •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
About this study
Official title: Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
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.
Read the detailed description
Background:
Depression is common in patients with diabetes and is associated with impaired glycemic control and elevated cortisol levels. 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 (BBAT) is a stress-reducing technique and is used in psychiatric care in Scandinavia in order to improve psychiatric health.
Purpose:
The aims are to: 1. Analyze the prevalence of depression and anxiety and the personality variables alexithymia and self image in diabetes patients at baseline. 2. Explore correlations between these variables and risk factors, including biochemical markers for diabetic complications. 3. To evaluate an intervention with Affect School with Script Analysis and Basal Body Awareness Therapy 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 in two steps. First step started in 2009 and consists of 350 people with diabetes, 90% with type 1 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 HbA1c >70 mmol/mol (A1c ≥ 8 %) and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image (SASB: Affinity dimension <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: 10 group meetings and 5individual sessions with a physiotherapist as instructor. Post intervention: Self report tests, A1c, cortisol.
Second step will start in 2015: Recruitment of 350 people from primary care with type 2 diabetes with high A1c and either depression, alexithymia, negative self image or anxiety. Randomization procedures and patient characteristics will be assessed in the same way as above.
- Conditions
- Diabetes Mellitus, Depression, Alexithymia, Anxiety
- Being tested
- Affect School, Body Awareness Therapy
- Keywords
- Diabetes mellitus, Depression, Anxiety, Alexithymia, Self Image, HbA1c, Psychoeducation
- Medical subject headings
- Diabetes Mellitus, Depression, Affective Symptoms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect SchoolBehavioural
Body Awareness TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Affect School | Active comparator | Psychological group education intervention Receives: Behavioral: Affect School |
| Body Awareness Therapy | Active comparator | Physiotherapeutic psychosomatic intervention Receives: Behavioral: Body Awareness Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Secondary outcomes (4)
Level of HbA1c
Compare the HbA1c level before and after intervention
Measured: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Alexithymia
Includes difficulty identifying and describing feelings and low capacity of introspection and reflection - assessed by Toronto Alexithymia Scale 20-items
Measured: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Anxiety
Assessed by Hospital Anxiety and Depression scale -Anxiety subscale (HADS-a)
Measured: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Self-image
Assessed by Structural Analysis of Social Behaviour -Affinity dimension (SASB - Aff)
Measured: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startMar 2009
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Not active
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- FoU Kronoberg, Landstinget Kronoberg
- Responsible party
- Sponsor
- Investigators
- Eva O Melin, MD, Principal investigator, Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714986
- Sponsor's protocol ID
- FoU-Kronoberg 4522
- Acronym
- ALEXIDIAB
- Status last verified
- Dec 2018
- First submitted
- 24 Oct 2012
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27121185
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact, Metabolic Control, Biological Stress Markers in Diabetes: Intervention With Affect School and Basal Body Awareness
- ClinicalTrials.gov ID
- NCT01714986
- Acronym / sponsor ID
- ALEXIDIAB / FoU-Kronoberg 4522
- Conditions
- Diabetes Mellitus, Depression, Alexithymia, Anxiety
- Keywords
- Diabetes mellitus, Depression, Anxiety, Alexithymia, Self Image, HbA1c, Psychoeducation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not active
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- FoU Kronoberg, Landstinget Kronoberg
- Study start
- Mar 2009
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Depression is common in patients with diabetes and is associated with impaired glycemic control and elevated cortisol levels. 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 (BBAT) is a stress-reducing technique and is used in psychiatric care in Scandinavia in order to improve psychiatric health.
Purpose:
The aims are to: 1. Analyze the prevalence of depression and anxiety and the personality variables alexithymia and self image in diabetes patients at baseline. 2. Explore correlations between these variables and risk factors, including biochemical markers for diabetic complications. 3. To evaluate an intervention with Affect School with Script Analysis and Basal Body Awareness Therapy 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 in two steps. First step started in 2009 and consists of 350 people with diabetes, 90% with type 1 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 HbA1c >70 mmol/mol (A1c ≥ 8 %) and anxiety (HAD ≥ 8), depression (HAD ≥ 8), negative self-image (SASB: Affinity dimension <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: 10 group meetings and 5individual sessions with a physiotherapist as instructor. Post intervention: Self report tests, A1c, cortisol.
Second step will start in 2015: Recruitment of 350 people from primary care with type 2 diabetes with high A1c and either depression, alexithymia, negative self image or anxiety. Randomization procedures and patient characteristics will be assessed in the same way as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affect School | Active comparator | Behavioral: Affect SchoolPsychological group education intervention |
| Body Awareness Therapy | Active comparator | Behavioral: Body Awareness TherapyPhysiotherapeutic psychosomatic intervention |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- •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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affect School | Behavioural | Affect School |
| Body Awareness Therapy | Behavioural | Body Awareness Therapy |
Primary outcome
Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c
Time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
a two-arm randomized controlled trial comparing Affect School and Basal Body Awareness Therapy
4 secondary outcomes
Level of HbA1c
Time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Alexithymia
Time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Anxiety
Time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Self-image
Time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Derived from this study: PubMed 27121185Melin 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva O Melin, MD principal investigator
Fou Kronoberg, Kronoberg County Council, Växjö, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Affect School and Body Awareness Therapy in people with Diabetes Mellitus and Depression, run by Lund University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention with Affect School with Script Analysis and Basic Basal Awareness Therapy in patients with diabetes, psychological symptoms and high HbA1c (time frame: First follow up after intervention about 2 years after baseline and terminal follow up 6 years from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.