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

Primary Purpose

Obesity, Depression, Cognitive Behavioral Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
CBT-based weight loss model
Control
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-Based Weight Loss Model

Control

Arm Description

CBT- Based weight loss model

Usual Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Change in Eating behavior assessed by BES-questionnaire
BES -questionnaire assess binge eating symptoms.
Change in Intuitive Eating behavior
assessed by IES2 (Intuitive Eating Scale) questionnaire,
Change in Physical acitivity
assessed by questionnaire assessing physical activity
Change in Sleep
assessed by questionnaire
Change in Use of alcohol and tobacco
assessed by questionnaire
Previous weight loss
assessed by questioinnaire
Change in Mood
assessed by BDI (Beck Depression Inventory) questionnaire
Change in Anxiety
assessed by BAI (Beck Anxiety Inventory) questionnaire
Change in Quality of life
Assesed by 15D questionnaire
Change in Self-efficacy: questionnaire
assessed by WEL questionnaire
Change in Sense of coherence
assesed by SOC13 (Sense of Coherence) questionnaire

Full Information

First Posted
August 28, 2019
Last Updated
May 23, 2022
Sponsor
Kuopio University Hospital
Collaborators
University of Oulu, Jyväskylä Central Hospital, Oulu University Hospital, University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT04513587
Brief Title
The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Oulu, Jyväskylä Central Hospital, Oulu University Hospital, University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Depression, Cognitive Behavioral Therapy, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized intervention study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT-Based Weight Loss Model
Arm Type
Experimental
Arm Description
CBT- Based weight loss model
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
CBT-based weight loss model
Intervention Description
Methods of cognitive behavioral psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Change in Weight
Description
Measured by scale on baseline, 1 year and 2 years
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Lipids
Description
Measured by laboratory analyses (total cholesterol,High-density lipoprotein, Low-density lipoprotein, Triglyserides
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Blood glucose
Description
Measured by laboratory analyses
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in c-reactive protein level
Description
Measured by laboratory analyses
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Glycated hemoglobin (HbA1c)
Description
Measured by laboratory analyses
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Waist circumference
Description
Measured by tape measure on baseline, 1 year and 2 years
Time Frame
baseline and change from baseline to 1 year and 2 years
Secondary Outcome Measure Information:
Title
Change in Eating behavior assessed by TFEQ-18 questionnaire
Description
Three Factor Eating questionnaire-18 measures three eating behavior traits: emotional eating, cognitive restraint and uncontrolled eating.
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Eating behavior assessed by BES-questionnaire
Description
BES -questionnaire assess binge eating symptoms.
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Intuitive Eating behavior
Description
assessed by IES2 (Intuitive Eating Scale) questionnaire,
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Physical acitivity
Description
assessed by questionnaire assessing physical activity
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Sleep
Description
assessed by questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Use of alcohol and tobacco
Description
assessed by questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Previous weight loss
Description
assessed by questioinnaire
Time Frame
baseline
Title
Change in Mood
Description
assessed by BDI (Beck Depression Inventory) questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Anxiety
Description
assessed by BAI (Beck Anxiety Inventory) questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Quality of life
Description
Assesed by 15D questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Self-efficacy: questionnaire
Description
assessed by WEL questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years
Title
Change in Sense of coherence
Description
assesed by SOC13 (Sense of Coherence) questionnaire
Time Frame
baseline and change from baseline to 1 year and 2 years

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna-Maria Teeriniemi, PhD
Phone
+358447113148
Email
anna-maria.teeriniemi@kuh.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Sanna Rajapolvi, MSc
Phone
+358447176209
Email
sanna.rajapolvi@kuh.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Maria Teeriniemi, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Maria Teeriniemi
Phone
+358447113148
Email
anna-maria.teeriniemi@kuh.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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