Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03647826 |
| Other study ID # |
2510 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2018 |
| Est. completion date |
November 26, 2019 |
Study information
| Verified date |
March 2023 |
| Source |
Norwegian Institute of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 (e.g. gymnastics), mental skills training (e.g.
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 (e.g. 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 people's 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 people's 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., & O'Kearney, 2009). However, most of the mental skills programs address
adolescents with symptoms of anxiety and depression, or at risk of developing mental
illnesses (e.g. Arnarson & Craighead, 2009).
Several mental health progammes have been evaluated in Norwegian schools; e.g. "Alle har en
psykisk helse", "Zippys venner", "Ungdom møter ungdom (STEP)", "Venn1.no" (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). Rose's 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 Rose's 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 Grieger's (1977) Rational Emotive Behaviour
Therapy (REBT) and Beck, Rush, Shaw, and Emery's (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 Rose's
proposition that a universal strategy is more effective than a high-risk strategy.
