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

September 22, 2011 updated by: Prof. Josef Niebauer M.D., Ph.D., Paracelsus Medical University

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

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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.

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)

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:

  • 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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Reinhold Fartacek, MD, MBA, Paracelsus Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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