The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients (MOHS2010)
Primary Purpose
Suicide, Hopelessness
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mountain hiking in the Austrian and Bavarian Alps
Sponsored by
About this trial
This is an interventional supportive care trial for Suicide focused on measuring Physical activity, mountain hiking, exercise, training program, hopelessness, chronic suicidality, depression, suicide attempt, suicide
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hiking first
Control first
Arm Description
This group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period.
This group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention.
Outcomes
Primary Outcome Measures
Hopelessness
Summary score BHS (Beck Hopelessness Scale; 20 items)
Secondary Outcome Measures
Exercise capacity
(Watts/kg)
Depression
BDI-2 summary score (Beck depression inventory 2, 21 items)
Anxiety
Summary score BAI (Beck anxiety inventory, 21 items)
Suicide ideation
Summary score BSI (Beck suicide ideation inventory, 21 items)
Quality of life
PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl)
Blood parameters of inflammation
Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17;
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)
health-related physical activity
IPAQ short version (International physical activity questionnaire, 2002)
Full Information
NCT ID
NCT01152086
First Posted
June 28, 2010
Last Updated
September 22, 2011
Sponsor
Paracelsus Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01152086
Brief Title
The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients
Acronym
MOHS2010
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paracelsus Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Hopelessness
Keywords
Physical activity, mountain hiking, exercise, training program, hopelessness, chronic suicidality, depression, suicide attempt, suicide
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hiking first
Arm Type
Active Comparator
Arm Description
This group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period.
Arm Title
Control first
Arm Type
Active Comparator
Arm Description
This group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention.
Intervention Type
Other
Intervention Name(s)
Mountain hiking in the Austrian and Bavarian Alps
Intervention Description
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)
Primary Outcome Measure Information:
Title
Hopelessness
Description
Summary score BHS (Beck Hopelessness Scale; 20 items)
Time Frame
18 weeks (3 time points)
Secondary Outcome Measure Information:
Title
Exercise capacity
Description
(Watts/kg)
Time Frame
18 weeks (3 time points)
Title
Depression
Description
BDI-2 summary score (Beck depression inventory 2, 21 items)
Time Frame
18 weeks (3 time points)
Title
Anxiety
Description
Summary score BAI (Beck anxiety inventory, 21 items)
Time Frame
18 weeks (3 time points)
Title
Suicide ideation
Description
Summary score BSI (Beck suicide ideation inventory, 21 items)
Time Frame
18 weeks (3 time points)
Title
Quality of life
Description
PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl)
Time Frame
18 weeks (3 time points)
Title
Blood parameters of inflammation
Description
Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17;
Time Frame
18 weeks (3 time points)
Title
suicide risk factors
Description
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)
Time Frame
18 weeks (daily)
Title
health-related physical activity
Description
IPAQ short version (International physical activity questionnaire, 2002)
Time Frame
18 weeks (3 time points)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhold Fartacek, MD, MBA
Organizational Affiliation
Paracelsus Medical University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
19692930
Citation
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.
Results Reference
background
PubMed Identifier
18046198
Citation
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.
Results Reference
background
PubMed Identifier
15488361
Citation
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.
Results Reference
background
PubMed Identifier
19114382
Citation
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.
Results Reference
background
PubMed Identifier
17924938
Citation
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.
Results Reference
background
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The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients
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