The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care

Study Overview
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Brief Summary
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The aim of this study is find out how CBT-based weight loss program affects on eating behavior, weight loss, mood symptoms and risk for coronary heart diseases and type 2 diabetes and applicability of the program to obesity treatment among patients with comorbid depression. Our hypothesis is that the CBT-based intervention improves long-term weight management results and supports positively the change in eating behavior and the risk for CHD on type 2 DM. The study is randomized controlled one-year intervention study with 1 year follow-up. Study subjects are adult obese (BMI>35) subjects with comorbid depression. Number of randomized study subjects will be 80, 40 in intervention group, 40 in control group. Intervention group will proceed through a 52-week CBT-based weight loss group intervention. The aim of the intervention is to modify eating behavior and lifestyle factors affecting weight and weight maintenance. There will be 22 group counselling of 90 minutes divided in five modules and also three individual person-centered counselling visit, during which participants had an opportunity to discuss their personal concerns about diet and weight loss plan. Control group will receive the usual care of obesity in Kuopio University hospital. (4-8 individual 45-minute visit conducted by dieticians) Study visits are at baseline and one and 2 years after baseline. For example eating behavior, health behavior, motivation and depression are studied with questionnaires. Weight, waist circumference, height and blood pressure are measured. Laboratory tests (lipid, glucose etc) are taken.

Official Title
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CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression. Effect on Eating Behavior, Weight Loss, Mood, and Risk of Coronary Artery Disease and Diabetes.

Conditions
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Obesity, Depression, Cognitive Behavioral Therapy, Weight Loss

Intervention / Treatment
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* Behavioral: CBT-based weight loss model
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2) BMI > 35 Exclusion Criteria: Psychotic disorder, schizoaffective disorder, psychotic depression or bipolar disorder Severe current substance abuse Serious psychiatric condition (i.e self-destructive or impulsive behavior) Clinically significant illness contraindicating weight loss (i.e cancer or severe heart disease) Simultaneous participation in another weight loss program Severe vision, hearing, motoric deficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-Based Weight Loss Model<br>CBT- Based weight loss model | Behavioral: CBT-based weight loss model<br>* Methods of cognitive behavioral psychotherapy<br>|
| Active Comparator: Control<br>Usual Care | Behavioral: Control<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Measured by scale on baseline, 1 year and 2 years | baseline and change from baseline to 1 year and 2 years | 
| Change in Lipids | Measured by laboratory analyses (total cholesterol,High-density lipoprotein, Low-density lipoprotein, Triglyserides | baseline and change from baseline to 1 year and 2 years | 
| Change in Blood glucose | Measured by laboratory analyses | baseline and change from baseline to 1 year and 2 years | 
| Change in c-reactive protein level | Measured by laboratory analyses | baseline and change from baseline to 1 year and 2 years | 
| Change in Glycated hemoglobin (HbA1c) | Measured by laboratory analyses | baseline and change from baseline to 1 year and 2 years | 
| Change in Waist circumference | Measured by tape measure on baseline, 1 year and 2 years | baseline and change from baseline to 1 year and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eating behavior assessed by TFEQ-18 questionnaire | Three Factor Eating questionnaire-18 measures three eating behavior traits: emotional eating, cognitive restraint and uncontrolled eating. | baseline and change from baseline to 1 year and 2 years | 
| Change in Eating behavior assessed by BES-questionnaire | BES -questionnaire assess binge eating symptoms. | baseline and change from baseline to 1 year and 2 years | 
| Change in Intuitive Eating behavior | assessed by IES2 (Intuitive Eating Scale) questionnaire, | baseline and change from baseline to 1 year and 2 years | 
| Change in Physical acitivity | assessed by questionnaire assessing physical activity | baseline and change from baseline to 1 year and 2 years | 
| Change in Sleep | assessed by questionnaire | baseline and change from baseline to 1 year and 2 years | 
| Change in Use of alcohol and tobacco | assessed by questionnaire | baseline and change from baseline to 1 year and 2 years | 
| Previous weight loss | assessed by questioinnaire | baseline | 
| Change in Mood | assessed by BDI (Beck Depression Inventory) questionnaire | baseline and change from baseline to 1 year and 2 years | 
| Change in Anxiety | assessed by BAI (Beck Anxiety Inventory) questionnaire | baseline and change from baseline to 1 year and 2 years | 
| Change in Quality of life | Assesed by 15D questionnaire | baseline and change from baseline to 1 year and 2 years | 
| Change in Self-efficacy: questionnaire | assessed by WEL questionnaire | baseline and change from baseline to 1 year and 2 years | 
| Change in Sense of coherence | assesed by SOC13 (Sense of Coherence) questionnaire | baseline and change from baseline to 1 year and 2 years |