DepressionNCT06281288
Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms
A study testing Cognitive-Behavioral Therapy and Exercise Training in people with Depression, run by Doaa Tammam Atia at 1 site in Egypt.
Trial summary
PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society… Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive-Behavioral Therapy and Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2023to Jul 2024
- 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 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Depression adolescent girls 2. All patients should be in school
Who cannot join
- obesity
- malignant diseases
- psychotic disorders or psychosis.
- Permanent long-term psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cognitive-Behavioral Therapy Combined With Exercise Training in Adolescent Females With Elevated Depression Symptoms
PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms
BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"
RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls.
Read the detailed description
The interventions start after assessment of depression to know the level of depression by using the Center for Epidemiological Studies Depression Scale for Children (CES-DC), and the exercise intervention consist of physical activity combined with Cognitive behavioral therapy. Group - A perform regular physical activity in addition to cognitive therapy, Group - B perform irregular physical activity in addition to cognitive therapy, Group - C cognitive therapy only
- Conditions
- Depression
- Being tested
- Cognitive-Behavioral Therapy, Exercise Training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
Cognitive behavioral therapy
Exercise TrainingOther
Moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities
| Study group | Role | What they receive |
|---|---|---|
| cognitive therapy with regular exercise | Experimental | In the form of regular exercise where each participant perform exercise training approximately 60-min 3 times per week for 12 weeks, each session includes a combination of moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities, with additional time for warm-up (5 min; 10% HRmax) and cool down (5 min). Receives: Behavioral: Cognitive-Behavioral Therapy; Other: Exercise Training |
| cognitive therapy with irregular exercise | Experimental | in form of irregular exercise training approximately 60-min once a week for 12 weeks, each session include a combination of moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities, with additional time for warm-up (5 min; 10% HRmax) and cool down (5 min). Receives: Behavioral: Cognitive-Behavioral Therapy; Other: Exercise Training |
| cognitive therapy only | Experimental | Cognitive behavioral therapy) CBT (techniques is co facilitated by a psychiatrist where participants attend 12 sessions during the 12 weeks of treatment. The intervention is 60-min weekly in group sessions Receives: Behavioral: Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies Depression Scale for Children (CES-DC),
is a 20-item self-report depression inventory with possible scores ranging from 0 to 60. Each response to an item is scored as follows: 0 = "Not At All" 1 = "A Little" 2 = "Some" 3 = "A Lot" However, items 4, 8, 12, and 16 are phrased positively, and thus are scored in the opposite order: 3 = "Not At All" 2 = "A Little" 1 = "Some" 0 = "A Lot" Higher CES-DC scores indicate increasing levels of depression.
Measured: First at baseline and then after 12 weeks of the exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start25 Dec 2023
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doaa Tammam Atia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doaa Tammam Atia, Suez University
- Investigators
- Sally MS Mahmoud, Dr., Principal investigator, Misr University for Science and Technology, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281288
- Sponsor's protocol ID
- P.T.REC/012/004754
- Status last verified
- May 2024
- First submitted
- 20 Feb 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication would be available after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive-Behavioral Therapy Combined With Exercise Training in Adolescent Females With Elevated Depression Symptoms
- ClinicalTrials.gov ID
- NCT06281288
- Acronym / sponsor ID
- P.T.REC/012/004754
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Doaa Tammam AtiaUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 28 Feb 2024 (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.
PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms
BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"
RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls.
Detailed description
The interventions start after assessment of depression to know the level of depression by using the Center for Epidemiological Studies Depression Scale for Children (CES-DC), and the exercise intervention consist of physical activity combined with Cognitive behavioral therapy. Group - A perform regular physical activity in addition to cognitive therapy, Group - B perform irregular physical activity in addition to cognitive therapy, Group - C cognitive therapy only
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive therapy with regular exercise | Experimental | Behavioral: Cognitive-Behavioral Therapy, Other: Exercise TrainingIn the form of regular exercise where each participant perform exercise training approximately 60-min 3 times per week for 12 weeks, each session includes a combination of moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities, with additional time for warm-up (5 min; 10% HRmax) and cool down (5 min). |
| cognitive therapy with irregular exercise | Experimental | Behavioral: Cognitive-Behavioral Therapy, Other: Exercise Trainingin form of irregular exercise training approximately 60-min once a week for 12 weeks, each session include a combination of moderate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities, with additional time for warm-up (5 min; 10% HRmax) and cool down (5 min). |
| cognitive therapy only | Experimental | Behavioral: Cognitive-Behavioral TherapyCognitive behavioral therapy) CBT (techniques is co facilitated by a psychiatrist where participants attend 12 sessions during the 12 weeks of treatment. The intervention is 60-min weekly in group sessions |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Depression adolescent girls 2. All patients should be in school
Key exclusion criteria (4 listed)
- obesity
- malignant diseases
- psychotic disorders or psychosis.
- Permanent long-term psychiatric medication
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 |
|---|---|---|
| Cognitive-Behavioral TherapyCognitive behavioral therapy | Behavioural | cognitive therapy only, cognitive therapy with irregular exercise, cognitive therapy with regular exercise |
| Exercise TrainingModerate intensity (~63% maximum heart rate; HRmax) aerobic (~25 min) and resistance (~25 min) activities | Other | cognitive therapy with irregular exercise, cognitive therapy with regular exercise |
Primary outcome
Center for Epidemiological Studies Depression Scale for Children (CES-DC),
Time frame: First at baseline and then after 12 weeks of the exercise program
is a 20-item self-report depression inventory with possible scores ranging from 0 to 60. Each response to an item is scored as follows: 0 = "Not At All" 1 = "A Little" 2 = "Some" 3 = "A Lot" However, items 4, 8, 12, and 16 are phrased positively, and thus are scored in the opposite order: 3 = "Not At All" 2 = "A Little" 1 = "Some" 0 = "A Lot" Higher CES-DC scores indicate increasing levels of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication would be available after the end of the study
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Sally MS Mahmoud, Dr. principal investigator
Misr University for Science and Technology, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy and Exercise Training in people with Depression, run by Doaa Tammam Atia 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 1 inclusion and 4 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 6 May 2024. 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?
Center for Epidemiological Studies Depression Scale for Children (CES-DC), (time frame: First at baseline and then after 12 weeks of the exercise program). 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 6 May 2024.