Depression Clinical Trial
Official title:
Depression and Diabetes Control Trial
This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c). Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care behaviour, diabetes acceptance and quality of life. The treatment group will be treated with a cognitive-behavioural group treatment comprising specific interventions to improve glycaemic control and reduce diabetes distress as well as depressive symptoms. The control group will receive treatment-as-usual. A total of 212 study participants will be included. A secondary study objective is to analyse associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with inflammatory markers.
Suboptimal glycaemic control is an established risk factor for the development of serious
long-term complications of diabetes. Moreover, it is associated with elevated risks of
significant hyperglycaemic acute events such as hyperosmolar hyperglycemic state or diabetic
ketoacidosis. Hence, patients with diabetes and persistent suboptimal glycaemic control are
at higher risk of having a rather poor prognosis.
Besides physiological and medical factors, psychological problems have been found to predict
suboptimal glycaemic control. A number of studies found depressive symptoms to be
independently associated with hyperglycaemia. Others focussed on diabetes-specific affective
problems - the so called diabetes distress - and suggested this factor to be of great
importance. Finally, some studies found that depressive symptoms and diabetes distress may
interact, with the coocurrence of these factors being associated with the highest risk or
suboptimal glycaemic control. The results correspond to other findings suggesting that both
depressive symptoms and diabetes distress are often associated with reduced diabetes
self-care, which can explain the associations of those factors with hyperglycaemia.
On the other hand, suboptimal glycaemic control could also be an explanation for affective
problems - either mediated by physiological mechanisms or psychological ones, e.g.
dissatisfaction or guilt. Hence, it is valid to assume that the link between depressive
symptoms and/or diabetes distress may be bidirectional - although evidence to support this
assumption is missing.
Following this evidence and background, the investigators designed the a to analyse the
relationships between suboptimal glycaemic control, depressive symptoms and diabetes distress
in diabetes using a prospective study design. The study is a randomized trial in which a
cognitive-behavioural group treatment is compared to a treatment-as-usual condition (standard
diabetes education) regarding their efficacy in improving suboptimal glycaemic control. 212
diabetes patients with suboptimal glycaemic control (HbA1c value > 7.5%) and elevated
depressive symptoms (Center for Epidemiologic Studies Depressions Scale score ≥ 16) and/or
elevated diabetes distress (Problem Areas In Diabetes Scale score ≥ 40) will be randomly
assigned to either the treatment group or treatment-as-usual. The primary outcome is the
improvement of suboptimal glycaemic control (reduction of HbA1c) in the 12-month follow-up.
As secondary outcomes positive baseline-to-follow up changes regarding depressive symptoms,
diabetes distress, diabetes self-care behaviour, diabetes acceptance and quality of life are
assessed.
A second study objective is to analyse cross-sectional and prospective associations of
suboptimal glycaemic control, depressive symptoms and diabetes distress with serum levels of
the following inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1 and Adiponectin.
Potential effects of the treatment groups on these markers will also be examined.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |