The Impact of Running Therapy on Mental Health of Youth in a Psychiatric Adolescent Department

NCT05430607 | Unknown

• 1 other identifier: 0119-21-ZIV
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. The control group will continue the treatment program as usual.

Conditions

Psychiatric Disorder; Mental Health Issue

Outcome Measures

Primary Outcomes (2)

• Change in depressive symptoms

  Depressive status will be measured using the Children Depression Inventory (CDI; Kovacs, 1992) before and after the intervention to assess the change in symptoms.

  1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)

• Change in anxiety symptoms

  Anxiety level will be measured by Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1997, 1999) before and after the intervention to assess the change in symptoms.

  1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)

Secondary Outcomes (4)

• Change in self compassion symptoms

  1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)

• Change in emotion regulation symptoms

  1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)

• Change in self-efficacy symptoms

  1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)

• self injurious behavior

  1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)

Other Outcomes (1)

• therapeutic components' effect on mental health

  10-11 weeks after the start of the intervention (at the end of intervention).

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will participate in a 9-week running program and will also continue their routine treatment program at the psychiatric ward.

Behavioral: Running therapy

Control group

NO INTERVENTION

The control group will continue their routine treatment program at the psychiatric ward.

Interventions

Running therapy BEHAVIORAL

A 9-week running program.

Intervention group

Eligibility Criteria

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

You may qualify if:

• year-olds.
• Expected to be under observation for at least 10 weeks at time of recruitment.
• Consent of the patients and their parents to participate in the randomized control trial

You may not qualify if:

• Acute psychosis or manic states
• Acute suicidality
• Extreme physical difficulties
• Anorexia Nervosa

Sponsors & Collaborators

• Tali Bertler: lead

Study Sites (1)

Psychiatric adolescent department, Ziv Medical Center

Safed, 1304300, Israel

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Tali Bertler, PhD

  Ziv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 parallel study arms

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: June 24, 2022
• Study Start: April 19, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)