Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03647826
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2018-07-17
Brief Title:
Mind Power - A CBT Based Program for Adolescents
Sponsor:
Norwegian Institute of Public Health
Organization:
Norwegian Institute of Public Health
Study Overview
Official Title:
Mind Power - A CBT Based Program for Adolescents Aimed at Developing Coping Skills
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to strengthen school achievement and positive mental health and to prevent and reduce school dropout and mental distress among high school students The researchers will scale up techniques that have already been proven highly effective in preventing common mental disorders depression anxiety in high risk groups indicated and selective prevention The researchers will disseminate these techniques to entire first year classes of high school students irrespective of risk factors universal prevention The study will report whether universal delivery in school of Mind Power - a Cognitive Behaviour Therapy CBT based programme - will strengthen school grades self-efficacy self-esteem self-regulation mental perceptions and well-being and prevent and reduce school dropout and symptoms of anxiety and depression In addition the researchers will analyse whether such universal delivery prevents more mental distress and is more cost-effective than when it is delivered only to those at high risk for school failure dropout or mental distress
Detailed Description:
Mind power MTE is a modification of the Coping With Depression CWD course Lewinsohn Weinstein Alper 1970 Lewinsohn Antonuccio Steinmetz Teri 1984 CWD is by far the most studied psycho-educational intervention Cuijpers Muños Clark Lewinsohn 2009 No other study has however tested these aims on a version of CWD MTE is The Adolescent Coping with Depression Course ACDC Børve 2012 In Norwegian Depresjonsmesting for ungdom DU and the newest version is Mestringskurs for ungdom -DU The name ACDC has been changed to MTE in this project to capture the target group
In Norway unlike physical health training eg gymnastics mental skills training eg psychological techniques in CBT is normally reserved for individuals in treatment or at risk for developing mental disorders However especially in Australia and USA universal mental skills training programmes in schools have shown positive long-term effects eg Harden et al 2001 Wells Barlow Stewart-Brown 2003
The researchers will address how innovative research may contribute to the development of high quality education in Norway and how to strengthen adolescents resilience and empowerment in order to meet the challenges in society and work life If the results in our project are positive this project may have great impact on policy making in the areas of both education and public mental health
Background Why promote mental health and prevent ill-health Depression costs society more than any other illness Helsedirektoratet 2015 and is one of the greatest contributors to burden of disease in Norway Folkehelseinstituttet 2016 Twelve per cent of both boys and girls in Norway report that they experience symptoms of depression NOVA 2014 Up to 80 of adolescents with mental health problems do not receive any treatment Essau 2005 Zachrisson Rödje Mykletun 2006 Individuals especially boys in need of help can be reluctant to contact the mental health system because of stigma associated with mental health problems Gulliver Griffiths Christensen 2010 Universally providing mental health skills in schools to enhancing young peoples social and emotional skills may compensate for this
Dropouts from high School Approximately 30 of adolescents in Norway do not complete high school Approximately one third who drop out end up on disability benefit due to mental illness mainly depression Øverland Glozier Krokstad Mykletun 2007 Sikveland 2013 Internalizing problems anxiety and depression seems to affect dropout significantly Melkevik et al 2016 This has severe consequences for later work abilities socioeconomic status and economic support disability pensions Falch Nyhus 2011 Bergslie 2013 Because of the relationship between school motivation mental health and academic achievements it may be important to include all adolescents Masten et al 2005 Gustavsson et al 2010
Reduce social differences Adolescents with multicultural backgrounds seek less help from the mental health system Guribye Sam 2008 Individuals without higher education receive less help from specialists Jensen 2009 Mykletun Skogen Knudsen 2010 These groups may benefit from mental health skills taught in high schools independently of socio-economic background If the MTE intervention works fewer adolescents may dropout from school
Initiatives in Schools Reviews of program evaluations show that interventions designed to promote young peoples cognitive behavioral emotional and social development can successfully enhance skills associated with mental wellbeing Browne 2004 Keleher Armstrong 2005 Ball 2010 There are several examples on mental skills training such as the Friends programme which has shown positive findings Barrett Farrell Ollendick Dadds 2006 along with the online CBT-programme MoodGym Calear Christensen Mackinnon Griffiths OKearney 2009 However most of the mental skills programs address adolescents with symptoms of anxiety and depression or at risk of developing mental illnesses eg Arnarson Craighead 2009
Several mental health progammes have been evaluated in Norwegian schools eg Alle har en psykisk helse Zippys venner Ungdom møter ungdom STEP Venn1no Aune Stiles 2009 Andersson et al 2009 Arnesen Breivik Johnsen 2005 Mishara Ystgaad 2006 However these programmes are aimed mainly at teaching children about general mental health not at teaching mental health skills universally in the classroom
Why universal dissemination Adolescent Coping with Depression Course ACDC has previously been tested on adolescents at risk for depression in a clinical setting with positive effects Garvik Idsoe Bru 2013 However as the prevention guru Geoffrey Rose stated If disease risk is widespread measures that decrease risk for everyone are more effective in reducing the burden of disease than a high-risk approach in which measures are targeted only to those individuals with a substantially increased risk for disease Because If disease rates rise continuously with higher levels of exposure to the risk factor the larger number of people with a small elevation in risk will usually contribute more disease cases to the total burden of disease than the smaller number of people exposed to a high risk Rose 2008 Roses prevention paradigm has been proven valid on physical health by Mackenbach et al 2012 and promising on mental health by Brugha et al 2011 Neither CWD or ACDC have ever been tested on a non-clinical classroom sample aimed at health promotion Because depression among young people is widespread the researchers expect Roses paradigm also to be valid on adolescent common mental disorder and disseminate MTE universally
Cognitive behaviour theory CBT Mental Techniques in Every-day life MTE is an adaption of the Adolescent Coping with Depression Course ACDC Børve 2012 ACDC has changed name to MTE to capture the target group ACDC is mainly based on Cognitive Behavior Theory CBT The techniques that individuals are taught in CBT are acknowledged as one of the most efficient interventions for preventing and reducing depression Clarke et al 1995 Cuijpers et al 2009 CBT delivered as group-therapy is effective in reducing major depression Rohde et al 2004 Rosselló Bernal Rivera-Medina 2012 The intention is to modify dysfunctional thinking and behaviour since these aspects are regarded as one of the main causes of depression A depressed individual is characterised as a person who has a negative internal dialog that maintains negative experiences and beliefs Weersing Rozenman Gonzalez 2009
METHOD Sample All first-year students in nine public high schools in the region of Østfold fylkeskommune and one school in Akershus fylkeskommune are implementing MTE in their ordinary school schedule The principals for each school have choosen which classes that will attend in the study The students in these classes are invited to attend the research project and respond to questionnaires It is voluntary to respond The target group is 16 and 17 years old students irrespective of school achievements and internalizing problems The sample consists of approximately 110 high school classes 2200 students The classes will be randomly divided into two groups see Design
Intervention The program teaches students how to reflect about situations and their thinking-style identify their own reaction-patterns to stressful events to predict and influence their reactions and to integrate this understanding and these skills into practice Examples of themes are how emotions emerge how thoughts and actions influence feelings how to change perspectives coping techniques and how to do exercises in these methods It combines interventions from Ellis and Griegers 1977 Rational Emotive Behaviour Therapy REBT and Beck Rush Shaw and Emerys 1979 cognitive behaviour therapy CBT In addition MTE has elements from meta-cognition Wells et al 2009 positive psychology Seligman 2006 social theories Bandura 1977 mindfulness and philosophy and modern neurobiological perspectives
In the current project only teachers will be course leaders and teach the students In CWD and ACDC course leaders have at least three years of relevant higher education often nurses or school-nurses and psychologist To be certified the course leader in MTE CWD and ACDC must complete a five-day intensive training program 36 hours The organization Fagakademiet educates course leaders and the training is held by a psychologist specialized in CBT There are standardized course leader manuals and textbooks In this project approximately 170 teachers will be trained in MTE The MTE course is once every week for 90 minutes across eight weeks and have two booster sessions After this project the teachers will be continuing this work because the school managements have decided to include MTE in the ordinary school plan MTE is not treatment of mental illness
Research questions
The researchers hypotheses that participating in Mind power will increase self-efficacy coping self-esteem self-control quality of life and perceptions of their mental health and reduce symptoms of anxiety and depression The researchers want to test the effects of Mind power on school grades and drop-out Separate analyses will be conducted on the whole intervention group vs the control group and on the high-risk group versus the low risk group HRG LRG The effects on all outcome measures will be examined after 1 year and there will be conducted a cost-effectiveness-analysis If more founding the data collection will end in 2037 the researchers have permission from The Norwegian National Research Ethics Committees The four main hypotheses
1 Mind power enhances school grades self-efficacy self-control self-esteem mental well-being and mental health perceptions compared to the control group
2 Mind power prevents and reduces school dropout and symptoms of depression and anxiety compared to the control group
3 More cases of prevented and reduced school dropout and symptoms of depression and anxiety are found in the LRG group than in the HRL group
4 Gain from prevented dropouts and mental distress among LGR and HRG exceed the costs of Mind power
Design The design is a longitudinal randomized controlled cluster trial where entire classes will be randomly divided into two groups The total sample will be measured when the first group starts Mind power The first group starts Mind power immediately and the second group starts Mind power after six months in the next semester The second group functions as a control group until beginning Mind power This delayed intervention design will allow us to differentiate between a natural increase in the outcome variables and an increase caused by Mind power in addition to comparing two Mind power interventions at follow up The students respond on questionnaires before the session starts on the first course day and at the end of the sessions on the last course day day 8 when the other group attend the course and follow-ups The students click on a link on iPads or Laptops when responding on the questionnaires The design makes us able to compare the two groups and analyze the immediate effects of MTE and the long-term effect over at least 1 year hopefully there will be follow-ups until 15 years if the project receive more founding and to test Roses proposition that a universal strategy is more effective than a high-risk strategy
In Norway unlike physical health training eg gymnastics mental skills training eg psychological techniques in CBT is normally reserved for individuals in treatment or at risk for developing mental disorders However especially in Australia and USA universal mental skills training programmes in schools have shown positive long-term effects eg Harden et al 2001 Wells Barlow Stewart-Brown 2003
The researchers will address how innovative research may contribute to the development of high quality education in Norway and how to strengthen adolescents resilience and empowerment in order to meet the challenges in society and work life If the results in our project are positive this project may have great impact on policy making in the areas of both education and public mental health
Background Why promote mental health and prevent ill-health Depression costs society more than any other illness Helsedirektoratet 2015 and is one of the greatest contributors to burden of disease in Norway Folkehelseinstituttet 2016 Twelve per cent of both boys and girls in Norway report that they experience symptoms of depression NOVA 2014 Up to 80 of adolescents with mental health problems do not receive any treatment Essau 2005 Zachrisson Rödje Mykletun 2006 Individuals especially boys in need of help can be reluctant to contact the mental health system because of stigma associated with mental health problems Gulliver Griffiths Christensen 2010 Universally providing mental health skills in schools to enhancing young peoples social and emotional skills may compensate for this
Dropouts from high School Approximately 30 of adolescents in Norway do not complete high school Approximately one third who drop out end up on disability benefit due to mental illness mainly depression Øverland Glozier Krokstad Mykletun 2007 Sikveland 2013 Internalizing problems anxiety and depression seems to affect dropout significantly Melkevik et al 2016 This has severe consequences for later work abilities socioeconomic status and economic support disability pensions Falch Nyhus 2011 Bergslie 2013 Because of the relationship between school motivation mental health and academic achievements it may be important to include all adolescents Masten et al 2005 Gustavsson et al 2010
Reduce social differences Adolescents with multicultural backgrounds seek less help from the mental health system Guribye Sam 2008 Individuals without higher education receive less help from specialists Jensen 2009 Mykletun Skogen Knudsen 2010 These groups may benefit from mental health skills taught in high schools independently of socio-economic background If the MTE intervention works fewer adolescents may dropout from school
Initiatives in Schools Reviews of program evaluations show that interventions designed to promote young peoples cognitive behavioral emotional and social development can successfully enhance skills associated with mental wellbeing Browne 2004 Keleher Armstrong 2005 Ball 2010 There are several examples on mental skills training such as the Friends programme which has shown positive findings Barrett Farrell Ollendick Dadds 2006 along with the online CBT-programme MoodGym Calear Christensen Mackinnon Griffiths OKearney 2009 However most of the mental skills programs address adolescents with symptoms of anxiety and depression or at risk of developing mental illnesses eg Arnarson Craighead 2009
Several mental health progammes have been evaluated in Norwegian schools eg Alle har en psykisk helse Zippys venner Ungdom møter ungdom STEP Venn1no Aune Stiles 2009 Andersson et al 2009 Arnesen Breivik Johnsen 2005 Mishara Ystgaad 2006 However these programmes are aimed mainly at teaching children about general mental health not at teaching mental health skills universally in the classroom
Why universal dissemination Adolescent Coping with Depression Course ACDC has previously been tested on adolescents at risk for depression in a clinical setting with positive effects Garvik Idsoe Bru 2013 However as the prevention guru Geoffrey Rose stated If disease risk is widespread measures that decrease risk for everyone are more effective in reducing the burden of disease than a high-risk approach in which measures are targeted only to those individuals with a substantially increased risk for disease Because If disease rates rise continuously with higher levels of exposure to the risk factor the larger number of people with a small elevation in risk will usually contribute more disease cases to the total burden of disease than the smaller number of people exposed to a high risk Rose 2008 Roses prevention paradigm has been proven valid on physical health by Mackenbach et al 2012 and promising on mental health by Brugha et al 2011 Neither CWD or ACDC have ever been tested on a non-clinical classroom sample aimed at health promotion Because depression among young people is widespread the researchers expect Roses paradigm also to be valid on adolescent common mental disorder and disseminate MTE universally
Cognitive behaviour theory CBT Mental Techniques in Every-day life MTE is an adaption of the Adolescent Coping with Depression Course ACDC Børve 2012 ACDC has changed name to MTE to capture the target group ACDC is mainly based on Cognitive Behavior Theory CBT The techniques that individuals are taught in CBT are acknowledged as one of the most efficient interventions for preventing and reducing depression Clarke et al 1995 Cuijpers et al 2009 CBT delivered as group-therapy is effective in reducing major depression Rohde et al 2004 Rosselló Bernal Rivera-Medina 2012 The intention is to modify dysfunctional thinking and behaviour since these aspects are regarded as one of the main causes of depression A depressed individual is characterised as a person who has a negative internal dialog that maintains negative experiences and beliefs Weersing Rozenman Gonzalez 2009
METHOD Sample All first-year students in nine public high schools in the region of Østfold fylkeskommune and one school in Akershus fylkeskommune are implementing MTE in their ordinary school schedule The principals for each school have choosen which classes that will attend in the study The students in these classes are invited to attend the research project and respond to questionnaires It is voluntary to respond The target group is 16 and 17 years old students irrespective of school achievements and internalizing problems The sample consists of approximately 110 high school classes 2200 students The classes will be randomly divided into two groups see Design
Intervention The program teaches students how to reflect about situations and their thinking-style identify their own reaction-patterns to stressful events to predict and influence their reactions and to integrate this understanding and these skills into practice Examples of themes are how emotions emerge how thoughts and actions influence feelings how to change perspectives coping techniques and how to do exercises in these methods It combines interventions from Ellis and Griegers 1977 Rational Emotive Behaviour Therapy REBT and Beck Rush Shaw and Emerys 1979 cognitive behaviour therapy CBT In addition MTE has elements from meta-cognition Wells et al 2009 positive psychology Seligman 2006 social theories Bandura 1977 mindfulness and philosophy and modern neurobiological perspectives
In the current project only teachers will be course leaders and teach the students In CWD and ACDC course leaders have at least three years of relevant higher education often nurses or school-nurses and psychologist To be certified the course leader in MTE CWD and ACDC must complete a five-day intensive training program 36 hours The organization Fagakademiet educates course leaders and the training is held by a psychologist specialized in CBT There are standardized course leader manuals and textbooks In this project approximately 170 teachers will be trained in MTE The MTE course is once every week for 90 minutes across eight weeks and have two booster sessions After this project the teachers will be continuing this work because the school managements have decided to include MTE in the ordinary school plan MTE is not treatment of mental illness
Research questions
The researchers hypotheses that participating in Mind power will increase self-efficacy coping self-esteem self-control quality of life and perceptions of their mental health and reduce symptoms of anxiety and depression The researchers want to test the effects of Mind power on school grades and drop-out Separate analyses will be conducted on the whole intervention group vs the control group and on the high-risk group versus the low risk group HRG LRG The effects on all outcome measures will be examined after 1 year and there will be conducted a cost-effectiveness-analysis If more founding the data collection will end in 2037 the researchers have permission from The Norwegian National Research Ethics Committees The four main hypotheses
1 Mind power enhances school grades self-efficacy self-control self-esteem mental well-being and mental health perceptions compared to the control group
2 Mind power prevents and reduces school dropout and symptoms of depression and anxiety compared to the control group
3 More cases of prevented and reduced school dropout and symptoms of depression and anxiety are found in the LRG group than in the HRL group
4 Gain from prevented dropouts and mental distress among LGR and HRG exceed the costs of Mind power
Design The design is a longitudinal randomized controlled cluster trial where entire classes will be randomly divided into two groups The total sample will be measured when the first group starts Mind power The first group starts Mind power immediately and the second group starts Mind power after six months in the next semester The second group functions as a control group until beginning Mind power This delayed intervention design will allow us to differentiate between a natural increase in the outcome variables and an increase caused by Mind power in addition to comparing two Mind power interventions at follow up The students respond on questionnaires before the session starts on the first course day and at the end of the sessions on the last course day day 8 when the other group attend the course and follow-ups The students click on a link on iPads or Laptops when responding on the questionnaires The design makes us able to compare the two groups and analyze the immediate effects of MTE and the long-term effect over at least 1 year hopefully there will be follow-ups until 15 years if the project receive more founding and to test Roses proposition that a universal strategy is more effective than a high-risk strategy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None