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

July 29, 2011 updated by: Dublin City University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The increase in the number of young people, particularly males, taking their own lives in Ireland has become a major cause for concern. Five times more men than women end their own lives in Ireland today. Research shows that young people, particularly men under 30 years are far less likely to attend their GP than adults aged over 30 years. Thus, young men who are suffering from depression and who are vulnerable to suicidal behaviour are not actively seeking the help they require. Young men are the group least likely to approach mental health services (Russell, Gaffney, Bergin & Bedford, 2004), despite suicide and depression being so prevalent among young Irish males. It is clear that approaches to suicide prevention in Irish society need to bridge the gap between young at-risk men and mental health services.

Research has shown that both psychotherapeutic interventions such as Cognitive Behavioural Therapy (CBT) and exercise interventions can be equally effective as pharmacotherapy in addressing some of the risk factors associated with suicide (Mead et al., 2008), including symptoms of depression. Cognitive-Behavioural Therapy (CBT) places emphasis on identifying and changing maladaptive beliefs and behaviours that contribute to emotional distress. CBT techniques aim to enhance self-control, rational problem-solving abilities and social skills; it is therefore unsurprising that CBT has proven to be beneficial in addressing indices of suicide risk such as depression and perceived social isolation (Barbe, Bridge, Birhamer, Kolko & Brent, 2004; Brown at al., 2005). In an attempt to make CBT more widely available and easily accessible to various populations, research groups are investigating the impact of internet delivered CBT programmes on indices of suicide risk, including depression. Internet delivered CBT programmes have been found to be as effective as face-to-face treatment (Anderson, 2009). Internet delivered CBT has been shown to significantly reduce levels of depression in young people living in Sweden (Anderson, Bergstrom, Hollandare et al., 2005). Research proposes that internet-based interventions represent a paradigm shift in treatment techniques and that internet delivered CBT should be pursued further as a treatment alternative for symptoms of depression (Anderson, 2009; Anderson et al., 2005).

There is a large body of research that supports the role of exercise in treating depressive symptoms. Both depression and feelings of hopelessness, principal indices of suicide, are found to be lower in adults who regularly engage in exercise compared to those who remain sedentary (Chioqueta & Stiles, 2007). In a study involving university students, Chioqueta and Stiles (2007) demonstrate that active engagement in physical activity was significantly associated with improvements in indices of suicide. Involvement in physical activity has been shown to produce positive mood states and subjective well-being as well as reducing stress levels (Fox, 1999).

Suicide prevention in Ireland requires an innovative approach, one that provides support and is easily accessible by young men and which promotes help-seeking behaviour and mental health awareness. It is possible that internet based CBT interventions present such an opportunity for delivering mental health promotion and encouraging help-seeking behaviour among young Irish men while reducing indices of suicide risk. Exercise interventions are similarly successful in reducing the risk factors associated with suicide in young men, such as severity of depressive symptoms. Thus the main aim of this study is to explore the effectiveness of a combined exercise and internet delivered CBT intervention in reducing indices of suicide in young men.

In addition, it has been suggested that Physical Self-Concept mediates the relationship between exercise and self-esteem which is in turn related to depression (Dishman, Hales, Ward et al., 2006). However the relationship between these variables over time as a result of an intervention has not yet been studied. Therefore a secondary aim of this present study is to explore the relationship between physical self-concept, self-esteem and depression throughout the duration of the proposed intervention. We will also examine if changes in body-fat composition and body circumference mediate the relationship between these variables.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Dublin City University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • '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 Names:
  • 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 Names:
  • '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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression (Beck Depression Inventory-II).
Time Frame: week 1
week 1
Depression (Becks Depression Inventory-II)
Time Frame: week 5
week 5
Depression (Becks Depression Inventory-II)
Time Frame: week 10
week 10
Depression (Becks Depression Inventory-II)
Time Frame: 8 week follow-up
8 week follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Perceived Social Support (Social provisions scale)
Time Frame: week 1
week 1
Physical Self-Description Questionnaire
Time Frame: week 1
week 1
Body Fat Composition
Time Frame: week 1
week 1
Body Circumference
Time Frame: week 1
week 1
Perceived Social Support (Social provisions scale)
Time Frame: week 5
week 5
Perceived Social Support (Social provisions scale)
Time Frame: week 10
week 10
Perceived Social Support (Social provisions scale)
Time Frame: 8 week follow-up
8 week follow-up
Physical Self-Description Questionnaire
Time Frame: week 5
week 5
Physical Self-Description Questionnaire
Time Frame: week 10
week 10
Physical Self-Description Questionnaire
Time Frame: 8 week follow up
8 week follow up
Body Fat Composition
Time Frame: week 5
week 5
Body Fat Composition
Time Frame: week 10
week 10
Body Fat Composition
Time Frame: 8 week follow up
8 week follow up
Body Circumference
Time Frame: week 5
week 5
Body Circumference
Time Frame: week 10
week 10
Body Circumference
Time Frame: 8 week follow-up
8 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dublin City University

Investigators

  • Principal Investigator: Nadine McGale, MSc, Dublin City University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

August 1, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/2009/096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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