NCT04662021

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

December 4, 2020

Last Update Submit

January 8, 2021

Conditions

Anxiety Depression Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Exercise group

EXPERIMENTAL
Other: Aerobic Exercises

Cognitive therapy group

EXPERIMENTAL
Other: Aerobic Exercises

Interventions

Aerobic ExercisesOTHER

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)

Cognitive therapy groupExercise group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • severe psychological conditions such as schizophrenia
  • severe depression
  • any physical condition that limit physical activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 10, 2020

Study Start

December 10, 2020

Primary Completion

February 10, 2021

Study Completion

February 25, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)