Clinical trial NCT00971217: Exploring the Effectiveness of the 'Back of the Net' Intervention on Indices of Physical and Psychological Measures
Official title: Exploring the Effectiveness of the 'Back of the Net' Intervention on Indices of Physical and Psychological Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Concept
Body Fat Composition
Depression
Perceived Social Support
Keywords: Internet based Cognitive-Behavioural Intervention
Exercise Intervention
Depression
Perceived Social Support
Physical Self-Concept
Lead sponsor: Dublin City University
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

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.

Eligibility 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

Primary outcomes:
measure: Depression (Beck Depression Inventory-II).
timeFrame: week 1
measure: Depression (Becks Depression Inventory-II)
timeFrame: week 5
measure: Depression (Becks Depression Inventory-II)
timeFrame: week 10
measure: Depression (Becks Depression Inventory-II)
timeFrame: 8 week follow-up
Secondary outcomes:
measure: Perceived Social Support (Social provisions scale)
timeFrame: week 1
measure: Physical Self-Description Questionnaire
timeFrame: week 1
measure: Body Fat Composition
timeFrame: week 1
measure: Body Circumference
timeFrame: week 1
measure: Perceived Social Support (Social provisions scale)
timeFrame: week 5
measure: Perceived Social Support (Social provisions scale)
timeFrame: week 10
measure: Perceived Social Support (Social provisions scale)
timeFrame: 8 week follow-up
measure: Physical Self-Description Questionnaire
timeFrame: week 5
measure: Physical Self-Description Questionnaire
timeFrame: week 10
measure: Physical Self-Description Questionnaire
timeFrame: 8 week follow up
measure: Body Fat Composition
timeFrame: week 5
measure: Body Fat Composition
timeFrame: week 10
measure: Body Fat Composition
timeFrame: 8 week follow up
measure: Body Circumference
timeFrame: week 5
measure: Body Circumference
timeFrame: week 10
measure: Body Circumference
timeFrame: 8 week follow-up
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Dublin City University
Study officials:
affiliation: Dublin City University
name: Nadine McGale, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Chioqueta AP, Stiles TC. Cognitive factors, engagement in sport, and suicide risk. Arch Suicide Res. 2007;11(4):375-90. doi: 10.1080/13811110600897143.
citation: 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.
citation: 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.
citation: 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.
citation: Fox KR. The influence of physical activity on mental well-being. Public Health Nutr. 1999 Sep;2(3A):411-8. doi: 10.1017/s1368980099000567.