Psychiatric DisorderNCT05430607
The Impact of Running Therapy on Mental Health of Youth in a Psychiatric Adolescent Department
A study testing Running therapy in people with Psychiatric Disorder and Mental Health Issue, run by Tali Bertler at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Psychiatric Disorder, Mental Health Issue
- What is being tested?
- Running therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Apr 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Acute psychosis or manic states
- Acute suicidality
- Extreme physical difficulties
- Anorexia Nervosa
Trial locations and contacts
1 site in 1 country.
Israel1 site
Psychiatric adolescent department, Ziv Medical Center
Safed, 1304300
About this study
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
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.
Read the 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.
- Conditions
- Psychiatric Disorder, Mental Health Issue
- Being tested
- Running therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running therapyBehavioural
A 9-week running program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Running therapy |
| Control group | No intervention | The control group will continue their routine treatment program at the psychiatric ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start19 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel study arms
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tali Bertler
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tali Bertler, Ziv Hospital
- Investigators
- Tali Bertler, PhD, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430607
- Sponsor's protocol ID
- 0119-21-ZIV
- Status last verified
- Jun 2022
- First submitted
- 5 Apr 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05430607
- Acronym / sponsor ID
- 0119-21-ZIV
- Conditions
- Psychiatric Disorder, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tali BertlerOther government
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 parallel study arms
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Running therapyThe intervention group will participate in a 9-week running program and will also continue their routine treatment program at the psychiatric ward. |
| Control group | No intervention | –The control group will continue their routine treatment program at the psychiatric ward. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Acute psychosis or manic states
- Acute suicidality
- Extreme physical difficulties
- Anorexia Nervosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Running therapyA 9-week running program. | Behavioural | Intervention group |
Primary outcome
Change in depressive 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)
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
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)
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.
4 secondary outcomes
Change in self compassion 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)
Change in emotion regulation 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)
Change in self-efficacy 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)
self injurious behavior
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tali Bertler, PhD principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running therapy in people with Psychiatric Disorder and Mental Health Issue, run by Tali Bertler at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.