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Self ConceptBTNNCT00971217

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

A study testing Exercise and Online Cognitive Behavioural Therapy in people with Self Concept and Body Fat Composition, run by Dublin City University at 1 site in Ireland.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Self Concept, Body Fat Composition, Depression
What is being tested?
Exercise and Online Cognitive Behavioural Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteIreland
Study dates
Aug 2010to Feb 2011
Phase
Interventional
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 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • Dublin City University

    Dublin, Dublin

Other trials in Ireland

About this study

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.

Read the 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.

Being tested
Exercise, Online Cognitive Behavioural Therapy
Keywords
Internet based Cognitive-Behavioural Intervention, Exercise Intervention, Depression, Perceived Social Support, Physical Self-Concept
Medical subject headings
Depression

What participants receive

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

  • ExerciseOther

    Also called Aerobic 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.

  • Online Cognitive Behavioural TherapyBehavioural

    Also called 'Back of the Net' Intervention

    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.

Study groups in NCT00971217
Study groupRoleWhat they receive
ExerciseExperimentalParticipants 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.
Receives: Other: Exercise
Online Cognitive Behavioural TherapyExperimentalParticipants 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.
Receives: Behavioral: Online Cognitive Behavioural Therapy
Combined Exercise/Online CBTExperimentalParticipants will simultaneously par-take in both the exercise and the online CBT conditions already outlined.
Receives: Other: Exercise; Behavioral: Online Cognitive Behavioural Therapy
ControlNo interventionIndividuals 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 being measured

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

  1. Depression (Beck Depression Inventory-II).

    Measured: week 1

  2. Depression (Becks Depression Inventory-II)

    Measured: week 5

  3. Depression (Becks Depression Inventory-II)

    Measured: week 10

  4. Depression (Becks Depression Inventory-II)

    Measured: 8 week follow-up

Secondary outcomes (16)
  1. Perceived Social Support (Social provisions scale)

    Measured: week 1

  2. Physical Self-Description Questionnaire

    Measured: week 1

  3. Body Fat Composition

    Measured: week 1

  4. Body Circumference

    Measured: week 1

  5. Perceived Social Support (Social provisions scale)

    Measured: week 5

  6. Perceived Social Support (Social provisions scale)

    Measured: week 10

  7. Perceived Social Support (Social provisions scale)

    Measured: 8 week follow-up

  8. Physical Self-Description Questionnaire

    Measured: week 5

  9. Physical Self-Description Questionnaire

    Measured: week 10

  10. Physical Self-Description Questionnaire

    Measured: 8 week follow up

  11. Body Fat Composition

    Measured: week 5

  12. Body Fat Composition

    Measured: week 10

  13. Body Fat Composition

    Measured: 8 week follow up

  14. Body Circumference

    Measured: week 5

  15. Body Circumference

    Measured: week 10

  16. Body Circumference

    Measured: 8 week follow-up

Timeline

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

  1. First posted3 Sep 2009 (estimated)
  2. Study startAug 2010
  3. Primary completionDec 2010
  4. Study completionFeb 2011

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 N/A
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971217
Sponsor's protocol ID
REC/2009/096
Acronym
BTN
Status last verified
Jul 2011
First submitted
2 Sep 2009
Last updated
1 Aug 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19230862
  • 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.

    PubMed 16260822
  • 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.

    PubMed 15106887
  • 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.

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

    PubMed 17882625
  • 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.

    PubMed 16719612
  • 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.

    PubMed 18843656
  • 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.

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

    PubMed 10610081

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Online Cognitive Behavioural Therapy in people with Self Concept and Body Fat Composition, run by Dublin City University at 1 site in Ireland.

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 4 inclusion and 4 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 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

Depression (Beck Depression Inventory-II). (time frame: week 1). The study lists 4 primary outcomes in all. 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 NCT00971217, which also lists 9 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 1 Aug 2011.

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