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

Obesity Clinical Trial

— PsyCognObe2  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513587
• Other study ID #: 510RA21
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Kuopio University Hospital
• Contact: Anna-Maria Teeriniemi, PhD
• Phone: +358447113148
• Email: anna-maria.teeriniemi[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Cognitive Behavioral Therapy
• Depression
• Depressive Disorder
• Obesity
• Weight Loss

Intervention

Behavioral:
• CBT-based weight loss model
Methods of cognitive behavioral psychotherapy
• Control
Treatment as usual

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (5)

Lead Sponsor	Collaborator
Kuopio University Hospital	Jyväskylä Central Hospital, Oulu University Hospital, University of Eastern Finland, University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Measured by scale on baseline, 1 year and 2 years	baseline and change from baseline to 1 year and 2 years
Primary	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
Primary	Change in Blood glucose	Measured by laboratory analyses	baseline and change from baseline to 1 year and 2 years
Primary	Change in c-reactive protein level	Measured by laboratory analyses	baseline and change from baseline to 1 year and 2 years
Primary	Change in Glycated hemoglobin (HbA1c)	Measured by laboratory analyses	baseline and change from baseline to 1 year and 2 years
Primary	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	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
Secondary	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
Secondary	Change in Intuitive Eating behavior	assessed by IES2 (Intuitive Eating Scale) questionnaire,	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Physical acitivity	assessed by questionnaire assessing physical activity	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Sleep	assessed by questionnaire	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Use of alcohol and tobacco	assessed by questionnaire	baseline and change from baseline to 1 year and 2 years
Secondary	Previous weight loss	assessed by questioinnaire	baseline
Secondary	Change in Mood	assessed by BDI (Beck Depression Inventory) questionnaire	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Anxiety	assessed by BAI (Beck Anxiety Inventory) questionnaire	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Quality of life	Assesed by 15D questionnaire	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Self-efficacy: questionnaire	assessed by WEL questionnaire	baseline and change from baseline to 1 year and 2 years
Secondary	Change in Sense of coherence	assesed by SOC13 (Sense of Coherence) questionnaire	baseline and change from baseline to 1 year and 2 years