SuicidePhase 4MOHS2010NCT01152086
The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients
A Phase 4 study testing Mountain hiking in the Austrian and Bavarian Alps in people with Suicide and Hopelessness, run by Paracelsus Medical University.
Trial summary
Suicide is a major public health issue with estimated 1 million deaths worldwide within the last year. Physical activity and nature recreation might be protective factors against suicidal behaviour, suicidal ideation and contributing factors like depression and hopelessness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Hopelessness
- What is being tested?
- Mountain hiking in the Austrian and Bavarian Alps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Dec 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronically suicidal defined as:
- at least one attempted suicide
- BHS summary scale > 26
Who cannot join
- Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
- not oriented in time and space
- demented
- acute psychotic
- cognitively impaired
- insufficient german language skills
About this study
Suicide is a major public health issue with estimated 1 million deaths worldwide within the last year. Physical activity and nature recreation might be protective factors against suicidal behaviour, suicidal ideation and contributing factors like depression and hopelessness.
In this randomized controlled cross-over intervention study the investigators aim to investigate the physical and psychological effects of a 9 weeks hiking program in chronically suicidal patients. The investigators aim to enroll 24 patients suffering from chronic suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests including questionnaires to assess suicide ideation, hopelessness, depression, anxiety, quality of life and health-related physical activity, physiological investigations to assess exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9 weeks supervised mountain hiking program followed by a 9-week-period without supervised exercise program. The other 12 patients start with 9 weeks without supervised exercise program followed by a 9-week-period of supervised mountain hiking program. The mountain hiking program includes 2 training sessions per week with a duration of 3 hours per session. The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics for body and nature perception, mobilisation and stretching will enrich the training program. Further investigations including questionnaire-assessments, assessment of exercise capacity and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition a daily assessment of several suicide risk-factors based on a web-based questionnaire will be done over the full study period. Within this mountain hiking program the investigators hope to reduce hopelessness in chronically suicidal patients.
- Conditions
- Suicide, Hopelessness
- Being tested
- Mountain hiking in the Austrian and Bavarian Alps
- Keywords
- Physical activity, mountain hiking, exercise, training program, hopelessness, chronic suicidality, depression, suicide attempt, suicide
- Medical subject headings
- Suicide, Motor Activity, Depression, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mountain hiking in the Austrian and Bavarian AlpsOther
Regularly supervised physical exercise training program.
Duration over all: 9 weeks; Frequency: 2 times per week; Duration one training-unit: 3 hours;
Program:
- Endurance training (performed within 70-85% of the maximum heart rate)
- Short exercises before hiking (Mobilisation, Body and nature perception, ca. 5 min)
- Stretching after hiking (ca. 5 min)
- Short break at half-time (ca. 15 min)
| Study group | Role | What they receive |
|---|---|---|
| Hiking first | Active comparator | This group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period. Receives: Other: Mountain hiking in the Austrian and Bavarian Alps |
| Control first | Active comparator | This group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention. Receives: Other: Mountain hiking in the Austrian and Bavarian Alps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopelessness
Summary score BHS (Beck Hopelessness Scale; 20 items)
Measured: 18 weeks (3 time points)
Secondary outcomes (8)
Exercise capacity
(Watts/kg)
Measured: 18 weeks (3 time points)
Depression
BDI-2 summary score (Beck depression inventory 2, 21 items)
Measured: 18 weeks (3 time points)
Anxiety
Summary score BAI (Beck anxiety inventory, 21 items)
Measured: 18 weeks (3 time points)
Suicide ideation
Summary score BSI (Beck suicide ideation inventory, 21 items)
Measured: 18 weeks (3 time points)
Quality of life
PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl)
Measured: 18 weeks (3 time points)
Blood parameters of inflammation
Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17;
Measured: 18 weeks (3 time points)
suicide risk factors
Several items:
- Grundwert aus dem Test zur existentiellen Motivation (Eckhard, 2000, 2 items)
- Burdensomeness and Connectedness (Interpersonal needs questionnaire, Joiner 2005, 3 items)
- Chronic Suicidality (Paris, 2007, 2 items)
- Suicidal Status Form (SSF, Jobes, 2006, 9 items)
- Emotionalität und Problembelastung (SNS-subscala, Schiepek, 9 items)
- Alcohol consumption (1 item)
- Sleep quality (1 item)
- Social support (F-SozU-S54, 4 items)
- Physical activity (IPAQ-short, 2 items)
- Environmental perception (3 items)
- Religiousness and spirituality (2 items)
Measured: 18 weeks (daily)
health-related physical activity
IPAQ short version (International physical activity questionnaire, 2002)
Measured: 18 weeks (3 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., Paracelsus Medical University
- Investigators
- Reinhold Fartacek, MD, MBA, Study chair, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152086
- Sponsor's protocol ID
- Hiking2010
- Acronym
- MOHS2010
- Status last verified
- Sep 2011
- First submitted
- 28 Jun 2010
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Babiss LA, Gangwisch JE. Sports participation as a protective factor against depression and suicidal ideation in adolescents as mediated by self-esteem and social support. J Dev Behav Pediatr. 2009 Oct;30(5):376-84. doi: 10.1097/DBP.0b013e3181b33659.
PubMed 19692930Brown DR, Galuska DA, Zhang J, Eaton DK, Fulton JE, Lowry R, Maynard LM. Psychobiology and behavioral strategies. Physical activity, sport participation, and suicidal behavior: U.S. high school students. Med Sci Sports Exerc. 2007 Dec;39(12):2248-57. doi: 10.1249/mss.0b013e31815793a3.
PubMed 18046198Simon TR, Powell KE, Swann AC. Involvement in physical activity and risk for nearly lethal suicide attempts. Am J Prev Med. 2004 Nov;27(4):310-5. doi: 10.1016/j.amepre.2004.07.003.
PubMed 15488361Taliaferro LA, Rienzo BA, Pigg RM Jr, Miller MD, Dodd VJ. Associations between physical activity and reduced rates of hopelessness, depression, and suicidal behavior among college students. J Am Coll Health. 2009 Jan-Feb;57(4):427-36. doi: 10.3200/JACH.57.4.427-436.
PubMed 19114382Tao FB, Xu ML, Kim SD, Sun Y, Su PY, Huang K. Physical activity might not be the protective factor for health risk behaviours and psychopathological symptoms in adolescents. J Paediatr Child Health. 2007 Nov;43(11):762-7. doi: 10.1111/j.1440-1754.2007.01217.x.
PubMed 17924938
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients
- ClinicalTrials.gov ID
- NCT01152086
- Acronym / sponsor ID
- MOHS2010 / Hiking2010
- Conditions
- Suicide, Hopelessness
- Keywords
- Physical activity, mountain hiking, exercise, training program, hopelessness, chronic suicidality, depression, suicide attempt
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jun 2010 (estimated)
- 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.
Suicide is a major public health issue with estimated 1 million deaths worldwide within the last year. Physical activity and nature recreation might be protective factors against suicidal behaviour, suicidal ideation and contributing factors like depression and hopelessness.
In this randomized controlled cross-over intervention study the investigators aim to investigate the physical and psychological effects of a 9 weeks hiking program in chronically suicidal patients. The investigators aim to enroll 24 patients suffering from chronic suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests including questionnaires to assess suicide ideation, hopelessness, depression, anxiety, quality of life and health-related physical activity, physiological investigations to assess exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9 weeks supervised mountain hiking program followed by a 9-week-period without supervised exercise program. The other 12 patients start with 9 weeks without supervised exercise program followed by a 9-week-period of supervised mountain hiking program. The mountain hiking program includes 2 training sessions per week with a duration of 3 hours per session. The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics for body and nature perception, mobilisation and stretching will enrich the training program. Further investigations including questionnaire-assessments, assessment of exercise capacity and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition a daily assessment of several suicide risk-factors based on a web-based questionnaire will be done over the full study period. Within this mountain hiking program the investigators hope to reduce hopelessness in chronically suicidal patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hiking first | Active comparator | Other: Mountain hiking in the Austrian and Bavarian AlpsThis group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period. |
| Control first | Active comparator | Other: Mountain hiking in the Austrian and Bavarian AlpsThis group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least one attempted suicide
- BHS summary scale > 26
Key exclusion criteria (6 listed)
- Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
- not oriented in time and space
- demented
- acute psychotic
- cognitively impaired
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 |
|---|---|---|
| Mountain hiking in the Austrian and Bavarian AlpsRegularly supervised physical exercise training program. Duration over all: 9 weeks; Frequency: 2 times per week; Duration one training-unit: 3 hours; Program: * Endurance training (performed within 70-85% of the maximum heart rate) * Short exercises before hiking (Mobilisation, Body and nature perception, ca. 5 min) * Stretching after hiking (ca. 5 min) * Short break at half-time (ca. 15 min) | Other | Control first, Hiking first |
Primary outcome
Hopelessness
Time frame: 18 weeks (3 time points)
Summary score BHS (Beck Hopelessness Scale; 20 items)
8 secondary outcomes
Exercise capacity
Time frame: 18 weeks (3 time points)
Depression
Time frame: 18 weeks (3 time points)
Anxiety
Time frame: 18 weeks (3 time points)
Suicide ideation
Time frame: 18 weeks (3 time points)
Quality of life
Time frame: 18 weeks (3 time points)
Blood parameters of inflammation
Time frame: 18 weeks (3 time points)
suicide risk factors
Time frame: 18 weeks (daily)
health-related physical activity
Time frame: 18 weeks (3 time points)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2011.
- Background: PubMed 19692930Babiss LA, Gangwisch JE. Sports participation as a protective factor against depression and suicidal ideation in adolescents as mediated by self-esteem and social support. J Dev Behav Pediatr. 2009 Oct;30(5):376-84. doi: 10.1097/DBP.0b013e3181b33659.
- Background: PubMed 18046198Brown DR, Galuska DA, Zhang J, Eaton DK, Fulton JE, Lowry R, Maynard LM. Psychobiology and behavioral strategies. Physical activity, sport participation, and suicidal behavior: U.S. high school students. Med Sci Sports Exerc. 2007 Dec;39(12):2248-57. doi: 10.1249/mss.0b013e31815793a3.
- Background: PubMed 15488361Simon TR, Powell KE, Swann AC. Involvement in physical activity and risk for nearly lethal suicide attempts. Am J Prev Med. 2004 Nov;27(4):310-5. doi: 10.1016/j.amepre.2004.07.003.
- Background: PubMed 19114382Taliaferro LA, Rienzo BA, Pigg RM Jr, Miller MD, Dodd VJ. Associations between physical activity and reduced rates of hopelessness, depression, and suicidal behavior among college students. J Am Coll Health. 2009 Jan-Feb;57(4):427-36. doi: 10.3200/JACH.57.4.427-436.
- Background: PubMed 17924938Tao FB, Xu ML, Kim SD, Sun Y, Su PY, Huang K. Physical activity might not be the protective factor for health risk behaviours and psychopathological symptoms in adolescents. J Paediatr Child Health. 2007 Nov;43(11):762-7. doi: 10.1111/j.1440-1754.2007.01217.x.
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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.
Reinhold Fartacek, MD, MBA study chair
Paracelsus Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mountain hiking in the Austrian and Bavarian Alps in people with Suicide and Hopelessness, run by Paracelsus Medical University.
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 6 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: finished, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hopelessness (time frame: 18 weeks (3 time points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152086, which also lists 5 linked publications.
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 23 Sep 2011; AzTrials last refreshed its copy on 8 Nov 2026.