Suicide Clinical Trial
— MOHS2010Verified date | September 2011 |
Source | Paracelsus Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Paracelsus Medical University | Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical Universtity Salzburg, Institute of Synergetics and Psychotherapy Research, Paracelsus Medical Universtity Salzburg, Suicide Prevention Research Program, Paracelsus Medical Universtity Salzburg |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hopelessness | Summary score BHS (Beck Hopelessness Scale; 20 items) | 18 weeks (3 time points) | No |
Secondary | Exercise capacity | (Watts/kg) | 18 weeks (3 time points) | No |
Secondary | Depression | BDI-2 summary score (Beck depression inventory 2, 21 items) | 18 weeks (3 time points) | Yes |
Secondary | Anxiety | Summary score BAI (Beck anxiety inventory, 21 items) | 18 weeks (3 time points) | No |
Secondary | Suicide ideation | Summary score BSI (Beck suicide ideation inventory, 21 items) | 18 weeks (3 time points) | No |
Secondary | 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) | No |
Secondary | Blood parameters of inflammation | Interleukin 1 beta, Interleukin 2, Interleukin 6, Interferon gamma, Interleukin 10, Interleukin 17; | 18 weeks (3 time points) | No |
Secondary | 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) | No |
Secondary | health-related physical activity | IPAQ short version (International physical activity questionnaire, 2002) | 18 weeks (3 time points) | No |
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