The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients (MOHS2010)

This study has been completed.
Sponsor:
Collaborators:
Suicide Prevention Research Program, Paracelsus Medical Universtity Salzburg
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical Universtity Salzburg
Institute of Synergetics and Psychotherapy Research, Paracelsus Medical Universtity Salzburg
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., Paracelsus Medical University
ClinicalTrials.gov Identifier:
NCT01152086
First received: June 28, 2010
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Suicide
Hopelessness
Other: Mountain hiking in the Austrian and Bavarian Alps
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Paracelsus Medical University:

Primary Outcome Measures:
  • Hopelessness [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    Summary score BHS (Beck Hopelessness Scale; 20 items)


Secondary Outcome Measures:
  • Exercise capacity [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    (Watts/kg)

  • Depression [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: Yes ]
    BDI-2 summary score (Beck depression inventory 2, 21 items)

  • Anxiety [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    Summary score BAI (Beck anxiety inventory, 21 items)

  • Suicide ideation [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    Summary score BSI (Beck suicide ideation inventory, 21 items)

  • Quality of life [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl)

  • Blood parameters of inflammation [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17;

  • suicide risk factors [ Time Frame: 18 weeks (daily) ] [ Designated as safety issue: No ]

    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 [ Time Frame: 18 weeks (3 time points) ] [ Designated as safety issue: No ]
    IPAQ short version (International physical activity questionnaire, 2002)


Estimated Enrollment: 24
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hiking first
This group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period.
Other: Mountain hiking in the Austrian and Bavarian Alps

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)
Active Comparator: Control first
This group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention.
Other: Mountain hiking in the Austrian and Bavarian Alps

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152086

Sponsors and Collaborators
Paracelsus Medical University
Suicide Prevention Research Program, Paracelsus Medical Universtity Salzburg
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical Universtity Salzburg
Institute of Synergetics and Psychotherapy Research, Paracelsus Medical Universtity Salzburg
Investigators
Study Chair: Reinhold Fartacek, MD, MBA Suicide Prevention Research Program, Paracelsus Medical Universtity Salzburg
  More Information

Publications:
Responsible Party: Prof. Josef Niebauer M.D., Ph.D., Prim. Prof. MD, PhD, MBA, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT01152086     History of Changes
Other Study ID Numbers: Hiking2010
Study First Received: June 28, 2010
Last Updated: September 22, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Paracelsus Medical University:
Physical activity
mountain hiking
exercise
training program
hopelessness
chronic suicidality
depression
suicide attempt
suicide

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 19, 2014