Clinical trial NCT05430607: The Impact of Running Therapy on Mental Health of Youth in a Psychiatric Adolescent Department
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Disorder
Mental Health Issue
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-24
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel study arms
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: 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)
measure: Change in anxiety symptoms
timeFrame: 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:
measure: Change in self compassion symptoms
timeFrame: 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)
measure: Change in emotion regulation symptoms
timeFrame: 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)
measure: Change in self-efficacy symptoms
timeFrame: 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)
measure: self injurious behavior
timeFrame: 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:
measure: therapeutic components' effect on mental health
timeFrame: 10-11 weeks after the start of the intervention (at the end of intervention).
Locations:
city: Safed
country: Israel
facility: Psychiatric adolescent department, Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Tali Bertler, PhD
role: PRINCIPAL_INVESTIGATOR
References: