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Completed

NCT Number: NCT01152086

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

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Depression Hopelessness Motor Activity Self-Injurious Behavior Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mountain hiking in the Austrian and Bavarian Alps

Other

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 outcomes

  1. Hopelessness

    Time frame: 18 weeks (3 time points)

    Summary score BHS (Beck Hopelessness Scale; 20 items)

Secondary outcomes

  1. Exercise capacity

    Time frame: 18 weeks (3 time points)

    (Watts/kg)

  2. Depression

    Time frame: 18 weeks (3 time points)

    BDI-2 summary score (Beck depression inventory 2, 21 items)

  3. Anxiety

    Time frame: 18 weeks (3 time points)

    Summary score BAI (Beck anxiety inventory, 21 items)

  4. Suicide ideation

    Time frame: 18 weeks (3 time points)

    Summary score BSI (Beck suicide ideation inventory, 21 items)

  5. 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)

  6. Blood parameters of inflammation

    Time frame: 18 weeks (3 time points)

    Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17;

  7. suicide risk factors

    Time frame: 18 weeks (daily)

    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)

  8. health-related physical activity

    Time frame: 18 weeks (3 time points)

    IPAQ short version (International physical activity questionnaire, 2002)

Sponsors and collaborators

Lead sponsor

Paracelsus Medical University

Other

Registry information

Acronym: MOHS2010

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2010
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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