NCT00971217

Brief Summary

To date very little research has focused on the mental health of young men. The main aim of the proposed research is to explore the effectiveness of a combined exercise and internet-based cognitive behavioral therapy (CBT) intervention (called "Back of the Net") on indices of suicide risk in young men. A second aim is to explore the relationship between physical self-concept, self esteem, body fat composition, body circumference and changes in depression as a result of an exercise intervention. It is hypothesised that the combined exercise and internet-delivered CBT intervention will have greater benefits for indices of suicide risk compared to an exercise-only intervention, an internet-delivered CBT-only intervention and a control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 1, 2011

Status Verified

July 1, 2011

Enrollment Period

4 months

First QC Date

September 2, 2009

Last Update Submit

July 29, 2011

Conditions

Keywords

Internet based Cognitive-Behavioural InterventionExercise InterventionDepressionPerceived Social SupportPhysical Self-Concept

Outcome Measures

Primary Outcomes (4)

  • Depression (Beck Depression Inventory-II).

    week 1

  • Depression (Becks Depression Inventory-II)

    week 5

  • Depression (Becks Depression Inventory-II)

    week 10

  • Depression (Becks Depression Inventory-II)

    8 week follow-up

Secondary Outcomes (16)

  • Perceived Social Support (Social provisions scale)

    week 1

  • Physical Self-Description Questionnaire

    week 1

  • Body Fat Composition

    week 1

  • Body Circumference

    week 1

  • Perceived Social Support (Social provisions scale)

    week 5

  • +11 more secondary outcomes

Study Arms (4)

Exercise

EXPERIMENTAL

Participants will engage in 2 exercise sessions each week for 10 weeks. Each session will last 50 minutes and will commence with a 5 minute warm up on the bike or treadmill and conclude with a 5 minute cool down. The participants will be required to exercise on their own without interference from others. Participants will wear heart rate monitors to ensure that they are exercising to moderate intensity (70-80% of age predicted maximum heart rate). Exercise: Aerobic exercise on the bike/cross trainer/ rower/ treadmill and resistance exercise on the weights machines.

Other: Exercise

Online Cognitive Behavioural Therapy

EXPERIMENTAL

Participants will be asked to log-on to a web-site specifically aimed at young men once per week and complete the set cognitive-behavioural tasks.

Behavioral: Online Cognitive Behavioural Therapy

Combined Exercise/Online CBT

EXPERIMENTAL

Participants will simultaneously par-take in both the exercise and the online CBT conditions already outlined.

Other: ExerciseBehavioral: Online Cognitive Behavioural Therapy

Control

NO INTERVENTION

Individuals will be advised that the start of their intervention will be delayed by 10 weeks. After 10 weeks individuals in the control condition will be given the opportunity to avail of an induction session in the gym and subsequently use the gym facilities for three sessions if they so desire. Participants will be asked to refrain from exercise for the 10 week study period.

Interventions

Moderate intensity aerobic exercise on the bike/cross trainer/ rower/ treadmill and resistance exercise on the weights machines, twice per week for 10 weeks.

Also known as: Aerobic exercise
Combined Exercise/Online CBTExercise

Participants will be asked to log-on to a website aimed at young men once per week. Participants will be asked to read a vignette or watch a specific video clip, which will be updated each week by the researcher. Participants will be asked to respond to the vignette/video clip on the website. This should take no longer than 10-15 minutes to complete. Different themes (such as those addressed by traditional cognitive behavioural therapy) will be introduced each week. Themes include: relaxation, identifying positive strengths, body image, goal-setting, problem-solving, resilience, self-care behaviour and sources of support.

Also known as: 'Back of the Net' Intervention
Combined Exercise/Online CBTOnline Cognitive Behavioural Therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males aged 18-40 years
  • Available twice a week for 10 weeks and willing to participate in moderate intensity exercise for 50 minutes at each session
  • Not regularly physically active (i.e., engages in a structured exercise session once or less per week)
  • Willing to participate in the internet-based CBT intervention once per week for 10 weeks

You may not qualify if:

  • Current illness or history of clinical conditions that prevents participation in exercise
  • Currently alcohol/drug abusing
  • Major cognitive or psychiatric impairments
  • Currently receiving medication for major psychiatric disorders, including depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dublin City University

Dublin, Dublin, Ireland

Location

Related Publications (9)

  • Andersson G. Using the Internet to provide cognitive behaviour therapy. Behav Res Ther. 2009 Mar;47(3):175-80. doi: 10.1016/j.brat.2009.01.010. Epub 2009 Feb 20.

    PMID: 19230862BACKGROUND
  • Andersson G, Bergstrom J, Hollandare F, Carlbring P, Kaldo V, Ekselius L. Internet-based self-help for depression: randomised controlled trial. Br J Psychiatry. 2005 Nov;187:456-61. doi: 10.1192/bjp.187.5.456.

    PMID: 16260822BACKGROUND
  • Barbe RP, Bridge J, Birmaher B, Kolko D, Brent DA. Suicidality and its relationship to treatment outcome in depressed adolescents. Suicide Life Threat Behav. 2004 Spring;34(1):44-55. doi: 10.1521/suli.34.1.44.27768.

    PMID: 15106887BACKGROUND
  • Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.

    PMID: 16077050BACKGROUND
  • Chioqueta AP, Stiles TC. Cognitive factors, engagement in sport, and suicide risk. Arch Suicide Res. 2007;11(4):375-90. doi: 10.1080/13811110600897143.

    PMID: 17882625BACKGROUND
  • Dishman RK, Hales DP, Pfeiffer KA, Felton GA, Saunders R, Ward DS, Dowda M, Pate RR. Physical self-concept and self-esteem mediate cross-sectional relations of physical activity and sport participation with depression symptoms among adolescent girls. Health Psychol. 2006 May;25(3):396-407. doi: 10.1037/0278-6133.25.3.396.

    PMID: 16719612BACKGROUND
  • Mead GE, Morley W, Campbell P, Greig CA, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004366. doi: 10.1002/14651858.CD004366.pub3.

    PMID: 18843656BACKGROUND
  • Russell V, Gaffney P, Collins K, Bergin A, Bedford D. Problems experienced by young men and attitudes to help-seeking in a rural Irish community. Ir J Psychol Med. 2004 Mar;21(1):6-10. doi: 10.1017/S0790966700008065.

    PMID: 30308724BACKGROUND
  • Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. doi: 10.1017/s1368980099000567.

    PMID: 10610081BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nadine McGale, MSc

    Dublin City University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

August 1, 2011

Record last verified: 2011-07

Locations