The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care (PsyCognObe2)

Kuopio University Hospital

Status: Enrolling

Conditions: Weight Loss; Obesity; Cognitive Behavioral Therapy; Depression

Treatments: Behavioral: CBT-based weight loss model; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04513587

510RA21

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

CBT-Based Weight Loss Model

Experimental group

Description:

CBT- Based weight loss model

Treatment:

Behavioral: CBT-based weight loss model

Control

Active Comparator group

Description:

Usual Care

Treatment:

Behavioral: Control