CClinicalTrials.gg
Enrolling by invitationNCT06281288Updated May 6, 2024

Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms

An interventional study of Cognitive-Behavioral Therapy and Exercise Training in Depression, sponsored by Doaa Tammam Atia. Enrolling by invitation at 1 site in Egypt. Open to female participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Doaa Tammam Atia · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
Female
01

Study 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 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

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Doaa Tammam Atia as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

    1. Depression adolescent girls 2. All patients should be in school

Exclusion criteria

Exclusion Criteria:

  1. obesity
  2. malignant diseases
  3. psychotic disorders or psychosis.
  4. Permanent long-term psychiatric medication
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    cognitive therapy with regular exercise

    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).

    Behavioral: Cognitive-Behavioral Therapy · Other: Exercise Training

  • Experimental
    cognitive therapy with irregular exercise

    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).

    Behavioral: Cognitive-Behavioral Therapy · Other: Exercise Training

  • Experimental
    cognitive therapy only

    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

    Behavioral: Cognitive-Behavioral Therapy

Interventions

  • BehavioralCognitive-Behavioral Therapy

    Cognitive behavioral therapy

  • OtherExercise Training

    Moderate intensity (\~63% maximum heart rate; HRmax) aerobic (\~25 min) and resistance (\~25 min) activities

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: First at baseline and then after 12 weeks of the exercise program

07

Study locations

1 site
  • doaa Tammam Atia
    Suez, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication would be available after the end of the study

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06281288
Lead sponsor
Doaa Tammam Atia
Responsible party
Doaa Tammam Atia (Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Suez University, P.O.Box:43221, Suez, Egypt, Suez University) — Sponsor-investigator
First posted
Feb 28, 2024
Start date
Dec 25, 2023
Primary completion
May 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
May 6, 2024

Study contacts

Sally MS Mahmoud, Dr.
principal investigator · Misr University for Science and Technology, Giza, Egypt.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion