Exploring the Effectiveness of the 'Back of the Net' Intervention on Indices of Physical and Psychological Measures (BTN)

This study has been completed.
Sponsor:
Information provided by:
Dublin City University
ClinicalTrials.gov Identifier:
NCT00971217
First received: September 2, 2009
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Self Concept
Body Fat Composition
Depression
Perceived Social Support
Other: Exercise
Behavioral: Online Cognitive Behavioural Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Exploring the Effectiveness of the 'Back of the Net' Intervention on Indices of Physical and Psychological Measures

Resource links provided by NLM:


Further study details as provided by Dublin City University:

Primary Outcome Measures:
  • Depression (Beck Depression Inventory-II). [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Depression (Becks Depression Inventory-II) [ Time Frame: week 5 ] [ Designated as safety issue: No ]
  • Depression (Becks Depression Inventory-II) [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Depression (Becks Depression Inventory-II) [ Time Frame: 8 week follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived Social Support (Social provisions scale) [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Physical Self-Description Questionnaire [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Body Fat Composition [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Body Circumference [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Perceived Social Support (Social provisions scale) [ Time Frame: week 5 ] [ Designated as safety issue: No ]
  • Perceived Social Support (Social provisions scale) [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Perceived Social Support (Social provisions scale) [ Time Frame: 8 week follow-up ] [ Designated as safety issue: No ]
  • Physical Self-Description Questionnaire [ Time Frame: week 5 ] [ Designated as safety issue: No ]
  • Physical Self-Description Questionnaire [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Physical Self-Description Questionnaire [ Time Frame: 8 week follow up ] [ Designated as safety issue: No ]
  • Body Fat Composition [ Time Frame: week 5 ] [ Designated as safety issue: No ]
  • Body Fat Composition [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Body Fat Composition [ Time Frame: 8 week follow up ] [ Designated as safety issue: No ]
  • Body Circumference [ Time Frame: week 5 ] [ Designated as safety issue: No ]
  • Body Circumference [ Time Frame: week 10 ] [ Designated as safety issue: No ]
  • Body Circumference [ Time Frame: 8 week follow-up ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: August 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise

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
Moderate intensity aerobic exercise on the bike/cross trainer/ rower/ treadmill and resistance exercise on the weights machines, twice per week for 10 weeks.
Other Name: Aerobic exercise
Experimental: Online Cognitive Behavioural Therapy
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
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.
Other Name: 'Back of the Net' Intervention
Experimental: Combined Exercise/Online CBT
Participants will simultaneously par-take in both the exercise and the online CBT conditions already outlined.
Other: Exercise
Moderate intensity aerobic exercise on the bike/cross trainer/ rower/ treadmill and resistance exercise on the weights machines, twice per week for 10 weeks.
Other Name: Aerobic exercise
Behavioral: Online Cognitive Behavioural Therapy
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.
Other Name: 'Back of the Net' Intervention
No Intervention: Control
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971217

Locations
Ireland
Dublin City University
Dublin, Ireland
Sponsors and Collaborators
Dublin City University
Investigators
Principal Investigator: Nadine McGale, MSc Dublin City University
  More Information

Publications:
Responsible Party: Nadine McGale, Dublin City University
ClinicalTrials.gov Identifier: NCT00971217     History of Changes
Other Study ID Numbers: REC/2009/096
Study First Received: September 2, 2009
Last Updated: July 29, 2011
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Dublin City University:
Internet based Cognitive-Behavioural Intervention
Exercise Intervention
Depression
Perceived Social Support
Physical Self-Concept

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014