Diabetes MellitusNCT01498614
Psychological Impact in Diabetes: Intervention With Affect School and Basal Body Awareness
A study testing Affect School and Basal body awareness in people with Diabetes Mellitus and Depression, run by Lund University at 1 site in Sweden.
Trial 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. 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 Basal body awareness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to 28 Nov 2018
- 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 and type 2 diabetes at a specialist outpatient clinic in Vaxjo
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
- Being tested
- Affect School and Basal body awareness
- Keywords
- Diabetes mellitus, depression, anxiety, negative self image, alexithymia, metabolic control, diabetes complications
- Medical subject headings
- Diabetes Mellitus, Depression, Affective Symptoms, Anxiety Disorders, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect School and Basal body awarenessBehavioural
Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method
| Study group | Role | What they receive |
|---|---|---|
| Affect school | Experimental | Affect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist Receives: 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 Receives: Behavioral: Affect School and Basal body awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression
Evaluate depression score before and after intervention
Measured: 3 years
Secondary outcomes (1)
Level of A1C
Compare the A1C level before and after intervention
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMar 2009
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Why it stopped: Investigator no longer at LU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Landstinget Kronoberg, Sweden
- Responsible party
- Sponsor
- Investigators
- Eva O Melin, MD, Principal investigator, Landstinget Kronoberg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498614
- Sponsor's protocol ID
- FoU-Kronoberg Sweden 4522
- Status last verified
- Nov 2018
- First submitted
- 21 Dec 2011
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact, Metabolic Control, and Biological Stress Markers in Diabetes: Intervention Study With Affect School and Basal Body Awareness
- ClinicalTrials.gov ID
- NCT01498614
- Acronym / sponsor ID
- FoU-Kronoberg Sweden 4522
- Conditions
- Diabetes Mellitus, Depression, Alexithymia, Anxiety
- Keywords
- Diabetes mellitus, depression, anxiety, negative self image, alexithymia, metabolic control, diabetes complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator no longer at LU.
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Landstinget Kronoberg, Sweden
- Study start
- Mar 2009
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 23 Dec 2011 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affect school | Experimental | Behavioral: Affect School and Basal body awarenessAffect school is an educational intervention which includes 8 group sessions followed by 10 individual meetings with therapist |
| Basal body awareness | Active comparator | Behavioral: Affect School and Basal body awarenessBasal body awareness is an educational method with 9 group sessions followed by 6 individual meetings |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Type 1 and type 2 diabetes at a specialist outpatient clinic in Vaxjo
Key exclusion criteria (6 listed)
- Other severe somatic disorder, including being deaf or blind.
- Severe psychiatric disorder requiring psychiatric specialist care;
- psychotic disorder,
- bipolar disorder,
- severe drug abuse.
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 and Basal body awarenessAffect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method | Behavioural | Affect school, Basal body awareness |
Primary outcome
Prevalence of depression
Time frame: 3 years
Evaluate depression score before and after intervention
1 secondary outcome
Level of A1C
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Investigator no longer at LU.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
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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
Landstinget Kronoberg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect School and Basal body awareness in people with Diabetes Mellitus and Depression, run by Lund University at 1 site in Sweden.
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 6 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: stopped early, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Investigator no longer at LU.). Results are not available in the source record.
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?
Prevalence of depression (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2018.