Depression Clinical Trial
Official title:
Exploring the Effectiveness of the 'Back of the Net' Intervention on Indices of Physical and Psychological Measures
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |