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

NCT06281288 | Enrolling By Invitation DMC

• 1 other identifier: P.T.REC/012/004754
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Outcome Measures

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.

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

Study Arms (3)

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).

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).

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

Behavioral: Cognitive-Behavioral Therapy

Interventions

Cognitive-Behavioral Therapy BEHAVIORAL

Cognitive behavioral therapy

cognitive therapy only; cognitive therapy with irregular exercise; cognitive therapy with regular exercise

Exercise Training OTHER

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

cognitive therapy with irregular exercise; cognitive therapy with regular exercise

Eligibility Criteria

• Age: 12 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Depression adolescent girls 2. All patients should be in school

You may not qualify if:

• obesity
• malignant diseases
• psychotic disorders or psychosis.
• Permanent long-term psychiatric medication

Sponsors & Collaborators

• Doaa Tammam Atia: lead

Study Sites (1)

doaa Tammam Atia

Suez, Egypt

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy; Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sally MS Mahmoud, Dr.

  Misr University for Science and Technology, Giza, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Suez University, P.O.Box:43221, Suez, Egypt

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: December 25, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 10 months
• Access Criteria: requesting the main author

Locations

EG (1)