- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152086
The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients (MOHS2010)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Chronically suicidal defined as:
- at least one attempted suicide
- BHS summary scale > 26
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hiking first
This group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period.
|
Regularly supervised physical exercise training program. Duration over all: 9 weeks; Frequency: 2 times per week; Duration one training-unit: 3 hours; Program:
|
|
Active Comparator: Control first
This group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention.
|
Regularly supervised physical exercise training program. Duration over all: 9 weeks; Frequency: 2 times per week; Duration one training-unit: 3 hours; Program:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hopelessness
Time Frame: 18 weeks (3 time points)
|
Summary score BHS (Beck Hopelessness Scale; 20 items)
|
18 weeks (3 time points)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise capacity
Time Frame: 18 weeks (3 time points)
|
(Watts/kg)
|
18 weeks (3 time points)
|
|
Depression
Time Frame: 18 weeks (3 time points)
|
BDI-2 summary score (Beck depression inventory 2, 21 items)
|
18 weeks (3 time points)
|
|
Anxiety
Time Frame: 18 weeks (3 time points)
|
Summary score BAI (Beck anxiety inventory, 21 items)
|
18 weeks (3 time points)
|
|
Suicide ideation
Time Frame: 18 weeks (3 time points)
|
Summary score BSI (Beck suicide ideation inventory, 21 items)
|
18 weeks (3 time points)
|
|
Quality of life
Time Frame: 18 weeks (3 time points)
|
PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl)
|
18 weeks (3 time points)
|
|
Blood parameters of inflammation
Time Frame: 18 weeks (3 time points)
|
Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17;
|
18 weeks (3 time points)
|
|
suicide risk factors
Time Frame: 18 weeks (daily)
|
Several items:
|
18 weeks (daily)
|
|
health-related physical activity
Time Frame: 18 weeks (3 time points)
|
IPAQ short version (International physical activity questionnaire, 2002)
|
18 weeks (3 time points)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Reinhold Fartacek, MD, MBA, Paracelsus Medical University
Publications and helpful links
General 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.
- Brown 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.
- Simon 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.
- Taliaferro 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.
- Tao 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hiking2010
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