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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05430607
• Other study ID #: 0119-21-ZIV
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: October 2023

Study information

• Verified date: June 2022
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: October 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Issue
• Problem Behavior
• Psychiatric Disorder

Intervention

Behavioral:
• Running therapy
A 9-week running program.

Locations

Country	Name	City	State
Israel	Psychiatric adolescent department, Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Tali Bertler

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)