Anxiety Depression DisorderNCT04662021
Aerobic Training Versus Cognitive Behavioral Therapy in Management of Anxiety
A study testing Aerobic Exercises in people with Anxiety Depression Disorder, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Anxiety Depression Disorder
- What is being tested?
- Aerobic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2020to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- severe psychological conditions such as schizophrenia
- severe depression
- any physical condition that limit physical activities
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Anxiety Depression Disorder
- Being tested
- Aerobic Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Other: Aerobic Exercises |
| Cognitive therapy group | Experimental | Not described Receives: Other: Aerobic Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start10 Dec 2020
- Primary completion10 Feb 2021 (estimated)
- Study completion25 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Depression DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662021
- Sponsor's protocol ID
- 12-2020
- Status last verified
- Jan 2021
- First submitted
- 4 Dec 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04662021
- Acronym / sponsor ID
- 12-2020
- Conditions
- Anxiety Depression Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Feb 2021 (estimated)
- Study completion
- 25 Feb 2021 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Aerobic Exercises |
| Cognitive therapy group | Experimental | Other: Aerobic Exercises |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- severe psychological conditions such as schizophrenia
- severe depression
- any physical condition that limit physical activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExercisesParticipants 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) | Other | Cognitive therapy group, Exercise group |
Primary outcome
DASS 21
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercises in people with Anxiety Depression Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASS 21 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.