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

Study Overview
=================
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.

Conditions
-----------------
Suicide, Hopelessness

Intervention / Treatment
-----------------
* Other: Mountain hiking in the Austrian and Bavarian Alps


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hiking first<br>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<br>* 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)<br>|
| Active Comparator: Control first<br>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<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopelessness | Summary score BHS (Beck Hopelessness Scale; 20 items) | 18 weeks (3 time points) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | (Watts/kg) | 18 weeks (3 time points) | 
| Depression | BDI-2 summary score (Beck depression inventory 2, 21 items) | 18 weeks (3 time points) | 
| Anxiety | Summary score BAI (Beck anxiety inventory, 21 items) | 18 weeks (3 time points) | 
| Suicide ideation | Summary score BSI (Beck suicide ideation inventory, 21 items) | 18 weeks (3 time points) | 
| Quality of life | 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 | Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17; | 18 weeks (3 time points) | 
| 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) | 18 weeks (daily) | 
| health-related physical activity | IPAQ short version (International physical activity questionnaire, 2002) | 18 weeks (3 time points) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, mountain hiking, exercise, training program, hopelessness, chronic suicidality, depression, suicide attempt, suicide