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).