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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06281288
Other study ID # P.T.REC/012/004754
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 25, 2023
Est. completion date July 2024

Study information

Verified date May 2024
Source Suez University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date July 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Female
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt doaa Tammam Atia Suez

Sponsors (1)

Lead Sponsor Collaborator
Doaa Tammam Atia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center for Epidemiological Studies Depression Scale for Children (CES-DC), 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
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