Aerobic Training Versus Cognitive Behavioral Therapy in Management of Anxiety

Sponsor

Cairo University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04662021

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Disorder	Other: Aerobic Exercises	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Effect of Aerobic Training Versus Cognitive Behavioral Therapy in Management of Anxiety, Depression and Stress-related to Covid 19 Pandemics Among University Students: a Comparative Study

Actual Study Start Date :

Dec 10, 2020

Anticipated Primary Completion Date :

Feb 10, 2021

Anticipated Study Completion Date :

Feb 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise group	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)
Experimental: Cognitive therapy group	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)

Arm

Intervention/Treatment

Experimental: Exercise group

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)

Experimental: Cognitive therapy group

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)

Outcome Measures

Primary Outcome Measures

DASS 21 [8 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Eid	Cairo		Egypt	2011

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Eid, assistant professor of physical therapy for surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT04662021

Other Study ID Numbers:

12-2020

First Posted:

Dec 10, 2020

Last Update Posted:

Jan 11, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Anxiety Disorders

Study Results

No Results Posted as of Jan 11, 2021