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

NCT ID: NCT04513587

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Depression Cognitive Behavioral Therapy Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized intervention study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBT-Based Weight Loss Model

CBT- Based weight loss model

Group Type EXPERIMENTAL

CBT-based weight loss model

Intervention Type BEHAVIORAL

Methods of cognitive behavioral psychotherapy

Control

Usual Care

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Treatment as usual

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT-based weight loss model

Methods of cognitive behavioral psychotherapy

Intervention Type BEHAVIORAL

Control

Treatment as usual

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oulu

OTHER

Sponsor Role collaborator

Jyväskylä Central Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna-Maria Teeriniemi, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Finland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna-Maria Teeriniemi, PhD

Role: CONTACT

+358447113148

Sanna Rajapolvi, MSc

Role: CONTACT

+358447176209

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna-Maria Teeriniemi

Role: primary

+358447113148

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

510RA21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Behavioural Therapy for Obesity
NCT00294268 COMPLETED PHASE2