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

Primary Purpose

Psychiatric Disorder, Mental Health Issue

Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Running therapy
Sponsored by
Tali Bertler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychiatric Disorder

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric adolescent department, Ziv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 5, 2022
Last Updated
June 19, 2022
Sponsor
Tali Bertler
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1. Study Identification

Unique Protocol Identification Number
NCT05430607
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tali Bertler

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Mental Health Issue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 parallel study arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will participate in a 9-week running program and will also continue their routine treatment program at the psychiatric ward.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will continue their routine treatment program at the psychiatric ward.
Intervention Type
Behavioral
Intervention Name(s)
Running therapy
Intervention Description
A 9-week running program.
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
Depressive status will be measured using the Children Depression Inventory (CDI; Kovacs, 1992) before and after the intervention to assess the change in symptoms.
Time Frame
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)
Title
Change in anxiety symptoms
Description
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.
Time Frame
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 Measure Information:
Title
Change in self compassion symptoms
Description
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.
Time Frame
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)
Title
Change in emotion regulation symptoms
Description
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.
Time Frame
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)
Title
Change in self-efficacy symptoms
Description
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.
Time Frame
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)
Title
self injurious behavior
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
therapeutic components' effect on mental health
Description
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.
Time Frame
10-11 weeks after the start of the intervention (at the end of intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tali Bertler, PhD
Organizational Affiliation
Ziv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric adolescent department, Ziv Medical Center
City
Safed
ZIP/Postal Code
1304300
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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