- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06281288
Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Suez, Egypt
- doaa Tammam Atia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Depression adolescent girls 2. All patients should be in school
Exclusion Criteria:
- obesity
- malignant diseases
- psychotic disorders or psychosis.
- Permanent long-term psychiatric medication
Study Plan
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).
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Cognitive behavioral therapy
Moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities
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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).
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Cognitive behavioral therapy
Moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities
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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
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Cognitive behavioral therapy
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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
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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.
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First at baseline and then after 12 weeks of the exercise program
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sally MS Mahmoud, Dr., Misr University for Science and Technology, Giza, Egypt.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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