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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Obesity; Weight Loss; Cognitive Behavioral Therapy
• Intervention / Treatment: Behavioral: CBT-based weight loss model; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna-Maria Teeriniemi, PhD; Phone Number: +358447113148; Email: anna-maria.teeriniemi@kuh.fi
• Study Contact Backup: Name: Sanna Rajapolvi, MSc; Phone Number: +358447176209; Email: sanna.rajapolvi@kuh.fi

Study Locations

• Finland
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Anna-Maria Teeriniemi; Phone Number: +358447113148; Email: anna-maria.teeriniemi@kuh.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Oulu University Hospital; University of Eastern Finland; University of Oulu; Jyväskylä Central Hospital
• Investigators: Principal Investigator: Anna-Maria Teeriniemi, PhD, Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Body Weight Changes; Depression; Depressive Disorder; Weight Loss; Body Weight
• Other Study ID Numbers: 510RA21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No