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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
Paracelsus Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 28, 2010
    Last Updated
    September 22, 2011
    Sponsor
    Paracelsus Medical University
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    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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