Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms

May 3, 2024 updated by: Doaa Tammam Atia

Effect of Cognitive-Behavioral Therapy Combined With Exercise Training in Adolescent Females With Elevated Depression Symptoms

PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms

BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"

RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The interventions start after assessment of depression to know the level of depression by using the Center for Epidemiological Studies Depression Scale for Children (CES-DC), and the exercise intervention consist of physical activity combined with Cognitive behavioral therapy. Group - A perform regular physical activity in addition to cognitive therapy, Group - B perform irregular physical activity in addition to cognitive therapy, Group - C cognitive therapy only

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Suez, Egypt
        • doaa Tammam Atia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Depression adolescent girls 2. All patients should be in school

Exclusion Criteria:

  1. obesity
  2. malignant diseases
  3. psychotic disorders or psychosis.
  4. Permanent long-term psychiatric medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive therapy with regular exercise
In the form of regular exercise where each participant perform exercise training approximately 60-min 3 times per week for 12 weeks, each session includes a combination of moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities, with additional time for warm-up (5 min; 10% HRmax) and cool down (5 min).
Behavioral: Cognitive-Behavioral Therapy
Cognitive behavioral therapy
Other: Exercise Training
Moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities
Experimental: cognitive therapy with irregular exercise
in form of irregular exercise training approximately 60-min once a week for 12 weeks, each session include a combination of moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities, with additional time for warm-up (5 min; 10% HRmax) and cool down (5 min).
Behavioral: Cognitive-Behavioral Therapy
Cognitive behavioral therapy
Other: Exercise Training
Moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities
Experimental: cognitive therapy only
Cognitive behavioral therapy) CBT (techniques is co facilitated by a psychiatrist where participants attend 12 sessions during the 12 weeks of treatment. The intervention is 60-min weekly in group sessions
Behavioral: Cognitive-Behavioral Therapy
Cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies Depression Scale for Children (CES-DC),
Time Frame: First at baseline and then after 12 weeks of the exercise program
is a 20-item self-report depression inventory with possible scores ranging from 0 to 60. Each response to an item is scored as follows: 0 = "Not At All" 1 = "A Little" 2 = "Some" 3 = "A Lot" However, items 4, 8, 12, and 16 are phrased positively, and thus are scored in the opposite order: 3 = "Not At All" 2 = "A Little" 1 = "Some" 0 = "A Lot" Higher CES-DC scores indicate increasing levels of depression.
First at baseline and then after 12 weeks of the exercise program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doaa Tammam Atia

Investigators

  • Principal Investigator: Sally MS Mahmoud, Dr., Misr University for Science and Technology, Giza, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication would be available after the end of the study

IPD Sharing Time Frame

10 months

IPD Sharing Access Criteria

requesting the main author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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