1.

Study Background and Rationale

Depression (D) is a disorder which negatively affects how a person feels,

thinks and acts whilst anxiety (A) disorder involves excessive feelings of

worry, fear and nervousness (APA, 2013). Individuals with D display signs

such as constantly feeling down or having no interest in activities they

previously enjoyed whilst individuals with A show signs such as persistent

worrying, racing heart and shaking. These two disorders are major issues

faced by children and adolescents and often occur together. Costello et.

al. (2003) found that approximately 20% of youth will experience a

depressive episode or an A disorder by the age of 18 years old.

Additionally, D and A disorders usually run a chronic and recurring course,

with comorbidity levels as high as 50% (Scholten et. al., 2013; Garber &

Weersing, 2010). This presents serious burdens for families and public

health. This is supported by Angold et.al., (1998) who showed that high

levels of parental burden resulted from their child mental-health problem

were a big reason for specialist mental-health services use (Ebert et. al.,

2015). Furthermore, D and A can lead to issues such as poor academic

performance, drug and alcohol misuse, impaired social and coping skills,

suicide risk, and physical health problems which all can persist into

adulthood (Werner-Seidler et. al., 2017). Furthermore, it can lead to

increased likelihood of other disorders such as conduct disorder

(Woodward & Fergusson 2001).

1.2 Treatments
Researchers have provided strong evidence-base for effective drug and

non-drug treatments of D and A. D and A disorder can be treated

similarly, for example both disorders respond to selective serotonin

reuptake and serotonin norepinephrine reuptake inhibitor medications

(Gorman et. al., 1999; Hidalgo et. al., 2007). D and A can also be treated

by psychotherapy for example, interpersonal therapy and problem-solving

therapy (Compton et. al., 2013). However, this study protocol will

primarily focus on the effectiveness of cognitive-behavioural therapy

(CBT) in treating D or A disorder.

1.2.1 Cognitive-Behavioural Therapy (CBT)

CBT derives from Becks (1976) cognitive model, which explains that three

levels of cognition are responsible for the persistence of A and D. These

include: 1. Negative self-schemas, 2. Cognitive Triad, and 3. Biased

information processing (Clark & Beck, 2010). CBT is another form of

psychotherapy and has been recommended as the first-line treatment for

D or A by the NICE guidelines (NICE, 2009). The main aims of CBT are to

teach individual different ways of thinking and behaving through focusing

on their thoughts, attitudes and beliefs (Bennett, 2011). The effectiveness

of CBT for A and D has been rigorously investigated, Butler et. al., 2006

meta-analysis showed that CBT was better than antidepressants when

treating adult D. It was also found that individuals with A disorder treated

with CBT showed between 60- 80-% of clinically significant improvements

at 6 and 12-month follow-up. (Butler et. al., 2006). Lastly another

research found that CBT appears to have enduring effects in treating D

and A which could rule out the need for extended medication treatment

(Hollon et. al., 2006).

Despite these findings, research has shown that around 80% of youths

with mental disorders receive no treatment, this is due to hesitation to

seek help due to the perceived stigma linked with mental disorders,

discomfort discussing mental disorders or a preference for self-help

(Elbert et. al., 2015). Another challenge with CBT is that the demand

cannot be reached from existing therapist resources and it is not cost-

effective (Kumar et. al., 2017). Therefore, this study protocol will provide

an alternative treatment but still produce equal effectiveness as face-to-

face CBT. The alternative treatment chosen is computerised-CBT (cCBT).

cCBT delivers the important basis of CBT through a technological device,

for example via a computer, tablet or phone (Cooney et. al., 2017).

Andersson et. al., (2014) meta-anlysis and systematic review showed that

cCBT vs face-to-face-CBT produced equivalent overall treatment effects in

adults with A or D. However, the amount of studies that compare cCBT vs

traditional-CBT is limited. Therefore, more research is required to

establish equivalence of the two treatment formats. Furthermore, their

analysis revealed there is far less known about the effectiveness of cCBT

for A and B in young people. Thus, the effectiveness of cCBT in that

population needs to be determined.

There are many different reasons why cCBT should be used as an

alternative treatment. Using cCBT can provide solutions for many of the

limitations associated with face-to-face-CBT (Ebert et. al., 2015). For

example, availability and accessibility will be improved as cCBT will be

able to increase the availability of traditional-CBT for mental disorders as

it will be portable and cost-effective as less time with the therapist is

required (Kumar et. al. 2017). Furthermore, due to the youth having

more practical knowledge about the internet the advantages of cCBT will

be more relevant in youths than in adults. Proudfoot (2004) stated that

when young adults are online, they feel empowered and are ensured

anonymity which makes them feel more comfortable and confident in

exploring sensitive issues. This is supported by Berger et. al., (2005)

who’s survey revealed that 7,014 internet users with stigmatised

conditions such as A and D were significantly more likely to retrieve

health information online instead of seeking information face-to-face

(Sethi, 2013). Furthermore, another survey revealed that approximately

28% of individuals with psychiatric conditions owned a computer

(Borzekowski et al., 2009). These findings indicate that computerised

distribution of health information, could be a crucial platform for people

who are unwilling to request for help face-to-face. Lastly, cCBT will work

extremely well in children and adolescent population due to the

interactivity and visual attractiveness of cCBT which will help engage

them better than adults.

However only one study has exclusively looked at the effectiveness of

cCBT for A and D in youth. Ebert et. al. 2015 conducted a meta-analysis

of randomised controlled trials examining if cCBT was effective for

treating symptoms of A or D in children or young adults. They found that

cCBT was superior over control when targeting A and D (Elbert et. al.,

2015). However, majority of studies in this population did not have

follow-up assessment with treatment vs control. Thus, long-term effects

of treatments could not be evaluated.

Preliminary findings seem to indicate that cCBT interventions are effective

and acceptable by youth but the literature in this field is limited. This

study aims to compare effectiveness of cCBt with traditional-CBT and

control in improving symptoms of D or A and well-being at pre-and-post-

treatment and at long-term follow up (>12 months) in young people. It

was hypothesised that traditional-cbt and cCBT will be superior than

control in reducing symptoms and that cCBT will be as effective as

traditional-CBT in improving A and D symptoms and mental well-being in

the long-term.

2. Study Configuration

Design

A 3 x 3 mixed between-within groups randomised control trial (RCT) will

be used. A and D symptoms will be assessed at 3 time points: 1.pre-

treatment, 2. Post-treatment, 3. Long-term follow-up (>12months).

Sample

Through G*power v.3.1 (Faul et. al., 2009) it was calculated that for a

medium effect size (f² = 0.25, a= 0.05) a minimum of 168 outpatients is

needed to achieve the required power level (power= 95%) for this study.

Participants will be randomly allocated to 1 out of 3 groups: 1. Face-to-

face-cbt, 2. cCBT or 3. Control group. Randomisation will be conducted

via Microsoft Excel (2019) random list generator function and following

that order.

Participants will be recruited through referrals by health-care

professionals in mental-health clinics, schools or youth centres located in

the Nottingham area who use Structured Clinical Interview for DSM-IV to

diagnose individuals with anxiety or depression. Inclusion criteria for this

study are: a) must be between the ages of 12-18, b) have a principal

diagnosis of mild or moderate D or A according to DSM-IV criteria c)

English-Speaking. Exclusion criteria for this study are: a) have a

diagnosed neurodevelopmental disorder such as autism or ADHD b) have

had evidence of past or current psychosis or suicidal ideation and c)

currently involved in any other form of treatment e.g. medication or

psychological. Participants who are deemed as suitable to be treated with

cCBT or CBT to treat their symptoms by health-care professionals and

meet the inclusion and not the exclusion criteria, will be invited to

participate in the experiment and be contacted by the team via telephone

where they will be informed with procedures, if participants are under the
age of 16, this procedure will be given to parents/guardians. Experimental

group 1 will have 56 participants who will receive face-to-face-CBT,

Experimental group 2 will have 56 participants who will receive cCBT and

the control group will have 56 participants. Participants and researchers

will not be masked to treatment assignment due to nature of the

intervention.

Measures

Primary outcomes:

The Depression and Anxiety Stress Scale (DASS-21) (Lovibond &

Lovibond 1995) is a self-report questionnaire which measures the

emotional states of D, A and stress. This scale consists of 21 items, 7

items per subscale. Participants will be asked to score each item on a

scale from 0 (did not apply to me at all) to 3 (applied to me very much).

In terms of scoring, sum scores will be retrieved by adding scores on the

items per subscale and multiplying it by 2. For the D subscale: 0–9

(Normal), 10–13 (Mild), 14–20 (Moderate), A subscale: 0–7 (Normal), 8–

9 (Mild), 10–14 (Moderate) and for the stress subscale are: 0–14

(Normal), 15–18 (Mild), 19–25 (Moderate). The DASS-21 has excellent

internal consistency for each subscale (D=.97, A=.92, Stress =.95).

It also has strong convergent validity with other instruments of D (Beck

Depression Inventory, r=.79) and A (Beck Anxiety Inventory, r=.85)

(Antony et. al., 1998).

The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

(Tennant et. al., 2007) is a shortened version of the WEMWBS. This scale

measures mental well-being. This scale consists of 7 statements on a 5-

point Likert-scale (“none of the time” to “all of the time”). It is scored by

summing the response to each item, with higher scores indicating higher

positive mental well-being. This scale has high internal consistency

(Cronbach's alpha was 0.89) (Tennant et. al., 2007)

Treatment

Young people have a short attention span. Spek et. al., (2007) found that

CBT was completed by 94.5% of participants vs 48.3% of participants in

the cCBT group. They suggested that the duration involved when

individuals completed treatment was too long to maintain their attention.

Furthermore, Eysenbach (2005) reported that online-based treatments

will be rejected if participant believe that the treatment is too demanding.

Therefore, instructions and duration of sessions will be shortened in this

protocol.

Face-to-face-CBT

Face-to-face-CBT aims to provide individuals with skills to help tackle

irrational thought patterns. In face-to-face-CBT individuals will have to

identify negative maladaptive thoughts using cognitive homework and

then substituting those thoughts with healthier ones. Techniques involved

within CBT include cognitive restructuring, problem-solving, behavioural

experiments, self-monitoring and coping-skills training. One session will

last up to 40 minutes.

cCBT – MoodGYM

MoodGYM is an online psychological therapy program, with proven

effectiveness in treating mild and moderate D and A and promoting

mental well-being in young people (https://moodgym.com.au/).

MoodGYM is based on the traditional face-to-face-CBT thus aims to

change negative thoughts and beliefs, improve interpersonal relationships

and self-esteem and teach important coping skills. It incorporates

cognitive principles such as cognitive restructuring, relationship between

thoughts and feelings, pleasant events scheduling, relaxation and

problem-solving. The program will consist 20 – 30 minutes interactive

modules which provide information, animated demonstrations, an online

workbook for quizzes and homework exercises, feedback assessment and

a downloadable relaxation audio file.

Control Group

Participants will not receive traditional-cbt or cCBT. However, they will be

able to access general information pages on their mental well-being on

the NHS choice website or look for non-study treatments in the 12-week

period, this can conclude GPs or school counsellor.

Procedure
Participants will be given a choice of venue to complete their treatment

sessions, this includes their local community centre, school or GP surgery.

These locations will have private spaces to conduct standard-cbt, access

to internet for cCBT and provide protected confidentiality. Before

treatment sessions commence, all participants will have an initial meeting

where all relevant questionnaires will be completed (demographic, DASS-

12, SWEMWBS) and informed consent obtained. Treatment groups will

complete 1 session of either face-to-face-CBT or cCBT per week for 12

weeks. All questionnaires and treatments will be administered by

registered psychologists. In face-to-face-CBT psychologists will conduct

standardised-CBT and in cCBT psychologist role will be to present the

program to participants and helpers will be present in case participants

require help or have any questions. After this period, the DASS-12 and

SWEMWBS will be re-administered to treatment and control groups at

post-treatment and at long-term follow-up (<12 months). All measures

will be recorded and scored. Lastly, any dropouts or attrition will be

accounted for and reported.

Ethics

Ethical approval will be obtained from the Nottinghamshire NHS Research

Ethics Committee. Participants will be sent information sheets and

consent forms to obtain both their signature and that of a

parent/guardian. They were ensured anonymity and that they could leave
experiment at any point. Once the experiment is completed those

allocated in the control group will be offered cCBT or face-to-face-CBT.

Data and Statistical Analysis

All data will be analysed on SPSS version 23. A mixed between-within

subjects’ ANOVA will be conducted. The between-groups factor will be the

different treatment groups (cCBT vs face-to-face-CBT vs control) and the

within-participants factor will be time (pre, post and at long-term). This

statistical test will test for differences in symptom severity and well-being

mean scores between the 3 groups at each time point. Analyses will test

for main effects and interactions.

3. Lay Summary

Depression and anxiety is a common problem in children and teenagers

and can affect how a person thinks, behaves, feels and relate to others. If

sadness fills most of your days or worries bury your mind that is not

normal and may mean you are experiencing real problems with

depression or anxiety. Depression and anxiety can cause problems in a

young person’s life, for example reduced academic achievement,

damaged social and coping skills, increased risk of other mental-health

problems and drug and alcohol abuse, these problems can continue into

adulthood. There are many ways to treat individuals with depression or

anxiety, these include medication and psychotherapy. However, one

treatment that has been recommended as the first-line treatment of

depression and anxiety in children and adolescents is Cognitive-

behavioural therapy (CBT). CBT is a talking therapy that can help a

person manage their problems by changing the way they think and

behave. Many studies have provided evidence of the effectiveness of CBT,

all showing improved symptom severity and mental well-being in young

people after a course of CBT. Despite, this around 80% of young people

with mental-health problems never seek any help. There are different

reasons for this, such as CBT is not readily available, but also because

young people and their parents fear the stigma associated with mental-

health problems. Many individuals are uncomfortable talking about these

problems and would prefer self-help. Thus, this protocol suggests that

computerised-CBT (cCBT) which delivers principles of CBT through a

computer should be used as an alternative treatment. cCBT will help with

the problems associated with CBT such as provide availability, anonymity,

and increase cost-effectiveness. Furthermore, the interactive appeal of

cCBT and young people’s knowledge of computers could enable them to

engage with cCBT even better than adults. There is some evidence of

effectiveness of cCBT to treat depression and anxiety in adults but, far

less known about how effective cCBT is for treating young people with

anxiety or depression. Therefore, this study will address the gap in the

research by examining if cCBT is as effective as CBT in treating anxiety

and depression symptoms and improving their well-being in young

people. 168 participants between the ages 12- 16 with a diagnosis of mild

or moderate depression or anxiety will take part in a 12-week programme

of either face-to-face-CBT, cCBT or control. Clinical assessments that

measure symptom severity and mental well-being will be assessed pre-

treatment, post-treatment and at long-term follow up to analyse

improvements and determine effectiveness of treatments. Implications of

the proposed study include using cCBT as an adjunct to other therapies.

Furthermore, this could lead to opportunities in potentially delivering cCBT

packages to children and adolescents on a larger scale such as through

school-based mental health programmes.

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