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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04662021
Other study ID # 12-2020
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 10, 2020
Est. completion date February 25, 2021

Study information

Verified date January 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anxiety and depression disorders (ADD) have the highest overall prevalence rate among psychiatric disorders in young females. Its manifestations are disabling, distressing a substantial negative impact on the quality of life. The purpose of this study was to compare the effect of cognitive-behavioral therapy and physical therapy on female students with mild to moderate anxiety and depression.


Description:

Female students of Taif University will be invited to participate in this study. 40 students will be assigned according to sample size calculation into the study as having mild to moderate anxiety and depression according to Depression, Anxiety and Stress Scale (DASS 21) most days of the week for at least six months. All study participants will sign an informed consent form. Screening for the physical activities in the last 7 days of all participants will be performed one day before starting the study protocol using The International Physical Activity Questionnaires (IPAQ) short form. The exclusion will be performed to severe psychological conditions such as schizophrenia and severe depression and any physical condition that limit physical activities. Also, participants who are taking any medications for the treatment of anxiety and depression will be excluded. Also, participants who had any abnormalities of the cardiovascular status that prevent them to perform the physical activities or reaching the target heart rate without risk as recommended by their primary care physician. The age range will be 18 to 25 years with a mean age of 21±0.75 years. Participants will be assigned into two groups: group A (GA) consists of 20 students and they will be instructed to increase their physical activities one hour daily, 5 days per week for 8 weeks of moderate to vigorous activities such as running, jumping, swimming, aerobics or dancing; and group B (GB) consists of 20 students and they will receive cognitive behavioral therapy for 8 sessions (once per week for 8 weeks).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date February 25, 2021
Est. primary completion date February 10, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - mild to moderate anxiety and depression according to Depression, Anxiety and Stress Scale (DASS 21) most days of the week for at least six months - Females Age 18-25 years Exclusion Criteria: - severe psychological conditions such as schizophrenia - severe depression - any physical condition that limit physical activities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic Exercises
Participants perform one hour of regular moderate to vigorous physical activities about (70 % to 90 %) of the maximum heart rate which was calculated according to this formula (HR max= 220- age)

Locations

Country Name City State
Egypt Marwa Eid Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary DASS 21 The DASS 21 is a 21 item self-report questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety 8 weeks
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