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

The Impact of Running Therapy on Mental Health of Youth in the In-patient and Daycare Centers of the Psychiatric Adolescent Department, Ziv Medical Center, Safed - A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychiatric Disorder; Mental Health Issue
• Intervention / Treatment: Behavioral: Running therapy

Detailed Description

Patients in the inpatient and daycare centers of the psychiatric adolescent department at Ziv Medical Center receive an intensive treatment program including medical management, psychotherapy (individual, groups, and family therapy), and suited educational and other extracurricular recreational activities. Despite growing evidence of the effective influence of aerobic physical activity and running therapy, it is not included in the intensive treatment program, and, as far as we know, it is not included in most psychiatric wards in Israel.

The aim of this study is to assess the effectiveness of combining a group based running therapy as part of the treatment program provided in the inpatient and day care centers of the psychiatric ward.

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.

Participants will have group running sessions for 1 hour, three times a week, for 12 weeks. Sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. The sessions will be at an open court near the hospital. It will be guided by a team that will address both physical and therapeutic aspects.

The intervention program will include running outside the hospital complex (Safed Stadium) 3 times a week for about an hour each time, for 12 weeks. Participants will be transported to the stadium in an organized manner where the therapeutic running training will be conducted by a team that will include the researcher, running coach, nursing staff and psychology students.

Sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. At the end of the session, the participants will be driven back to the inpatient ward and day care centers.

Participants from the intervention group will be given specific group running T-shirts. Every week they will be given motivation band bracelets. The control group will be given similar items. Also, both groups will be given running shoes.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel, 1304300
    • Psychiatric adolescent department, Ziv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 12-18-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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; A 9-week running program.
No Intervention: Control group; The control group will continue their routine treatment program at the psychiatric ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self compassion symptoms	Self-compassion will be measured by The Self-Compassion Scale-Short Form (SCS-SF; Raes, Pommier, Neff, & Van Gucht, 2011) 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 emotion regulation symptoms	Emotion dysregulation will be measured by16-item version of the Difficulty in Emotion Regulation Scale (DERS-16; Bjureberg et al., 2016) 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 self-efficacy symptoms	Self-Efficacy will be measured by the 10 item General Self Efficacy Scale (GSES; Schwarzer, & Jerusalem, 1979, 1981, 1995) 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)
self injurious behavior	Self-injury will be measured by Direct self-injurious behaviors (D-SIB, i.e., selfinjury) 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
therapeutic components' effect on mental health	A specially designed questionnaire will address the effect on the therapeutic relationship and satisfaction that will include aspects of therapeutic alliance with the therapist, group aspects of treatment and the physical parts from the run itself.	10-11 weeks after the start of the intervention (at the end of intervention).

Collaborators and Investigators

• Sponsor: Tali Bertler
• Investigators: Principal Investigator: Tali Bertler, PhD, Ziv Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 0119-21-ZIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No