AzTrials
AzTrials

SuicidePhase 4MOHS2010NCT01152086

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

A Phase 4 study testing Mountain hiking in the Austrian and Bavarian Alps in people with Suicide and Hopelessness, run by Paracelsus Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide, Hopelessness
What is being tested?
Mountain hiking in the Austrian and Bavarian Alps
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Jul 2010to Dec 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronically suicidal defined as:
  • at least one attempted suicide
  • BHS summary scale > 26

Who cannot join

  • 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

About this study

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.

Being tested
Mountain hiking in the Austrian and Bavarian Alps
Keywords
Physical activity, mountain hiking, exercise, training program, hopelessness, chronic suicidality, depression, suicide attempt, suicide
Medical subject headings
Suicide, Motor Activity, Depression, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mountain hiking in the Austrian and Bavarian AlpsOther

    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)
Study groups in NCT01152086
Study groupRoleWhat they receive
Hiking firstActive comparatorThis group first starts with mountain hiking over 9 weeks followed by a 9 weeks control period.
Receives: Other: Mountain hiking in the Austrian and Bavarian Alps
Control firstActive comparatorThis group first starts with the control period (9 weeks) followed by the 9 weeks mountain hiking intervention.
Receives: Other: Mountain hiking in the Austrian and Bavarian Alps

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hopelessness

    Summary score BHS (Beck Hopelessness Scale; 20 items)

    Measured: 18 weeks (3 time points)

Secondary outcomes (8)

  1. Exercise capacity

    (Watts/kg)

    Measured: 18 weeks (3 time points)

  2. Depression

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

    Measured: 18 weeks (3 time points)

  3. Anxiety

    Summary score BAI (Beck anxiety inventory, 21 items)

    Measured: 18 weeks (3 time points)

  4. Suicide ideation

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

    Measured: 18 weeks (3 time points)

  5. Quality of life

    PLC (Profil der Lebensqualität Chronisch Kranker, 6 subscales: Leistungsvermögen, Genuß- und Entspannungsfähigkeit, Positive Stimmung, Negative Stimmung, Kontaktvermögen, Zugehörigkeitsgefühl)

    Measured: 18 weeks (3 time points)

  6. Blood parameters of inflammation

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

    Measured: 18 weeks (3 time points)

  7. 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)

    Measured: 18 weeks (daily)

  8. health-related physical activity

    IPAQ short version (International physical activity questionnaire, 2002)

    Measured: 18 weeks (3 time points)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01152086
Sponsor's protocol ID
Hiking2010
Acronym
MOHS2010
Status last verified
Sep 2011
First submitted
28 Jun 2010
Last updated
23 Sep 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19692930

  • 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.

    PubMed 18046198

  • 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.

    PubMed 15488361

  • 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.

    PubMed 19114382

  • 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.

    PubMed 17924938

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mountain hiking in the Austrian and Bavarian Alps in people with Suicide and Hopelessness, run by Paracelsus Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hopelessness (time frame: 18 weeks (3 time points)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01152086, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in