Core elements of Cognitive Behavioural Therapy in treatment of depression in youth: does the type and sequence of elements matter

Depression is one of the most prevalent mental disorders among adolescents, and
a major public health concern (Merikangas et al., 2010). Besides a high
prevalence, adolescents* depression is associated with comorbid psychiatric
diagnoses (Cooper & Goodyer, 1993), high treatment costs (Meijer et al., 2006),
social impairments (Verboom, Sijtsema, Verhulst, & Penninx, 2014), poor
academic performance (Fletcher, 2008), and suicide (Portzky & Van Heeringen,
2009).
Treatment programs based on the principles of Cognitive Behavioural
Therapy (CBT) appear most effective and most applied for depression among
adolescents (e.g., Cuijpers, Muñoz, Clarke, & Lewinsohn, 2009). Most common
CBT-elements for depression in adolescents are cognitive restructuring,
behavioral activation, relaxation, and training of problem-solving skills
(Weersing, Rozenman & Gonzales, 2009). Although empirical evidence for the
effectiveness of these specific elements is scarce (Horowitz, & Garber, 2006),
a recent meta analysis identified two CBT elements, behavioral activation and
cognitive restructuring, as contributing most to the effectiveness of CBT (Oud
et al., in preparation). Both modules were reported as greatly effective in
reducing depressive symptoms (Ng, Eckshtain & Weisz, 2015). Moreover,
adolescents who received CBT treatment reported the feasibility of cognitive
restructuring and behavioral activation as high (Ng, Eckshtain & Weisz, 2015).
Behavioral activation is a structured approach of increasing social,
physical or successful activities that can elicit positive experiences and
counteract the typical patterns of withdrawal and inactivity that characterize
depression. The activity level is gradually increased and obstacles in avoiding
difficult activities are addressed (e.g., Dimidjian, Barrera, Martell, Muñoz, &
Lewinsohn, 2011). As such, this approach may have a beneficial effect on
depression by reducing the inactivity (resulting, e.g., in school refusal)
which can occur due to depressive symptoms (Scharree, 2007).
Cognitive restructuring is focused on learning to identify negative
aspects of thoughts, to systematically evaluate the accuracy and helpfulness of
thoughts, and to modify it into a more balanced appraisal of their problems
(Wenzel, Dobson, & Hays, 2016). As such, this cognition-focused approach may
improve depressive symptomatology, for example, by targeting the negative bias
present during information processing common amongst adolescents with
depressive disorder (Axelson & Birmaher, 2001). However, although cognitions
play an important role in the theoretical explanation of mood disorders and may
therefore provide a welcome target for reducing depression (e.g., Beck, 1979),
cognitive ability to reflect on their own core beliefs has not yet fully
developed in adolescents (e.g., Longmore & Worrell, 2007).
Empirical evidence on the specific effects of these core modules of CBT
is scarce, and there is no to little empirical support for how exactly these
elements should be offered*i.e., what their optimal sequencing is. Hence, there
is a need for clarification regarding the specific differential effects of the
two seemingly most effective CBT-modules, behavioural activation and cognitive
restructuring, in adolescents with depression. Moreover, no research has
specifically evaluated the sequential effect of the cognitive restructuring and
behavioural activation modules in depressed adolescents, despite the need for
treatment optimalization. Therefore, the proposed STARr study aims to
investigate and provide insights into the differential and sequential
effectiveness these two most commonly used CBT-elements: behavioural activation
and cognitive restructuring. This knowledge can be used for recommendations to
optimize CBT-programs for treatment of depression in adolescents.

Primary Objective:
The primary objective is to establish the differential and sequential
effectiveness of cognitive restructuring (CR) and behavioral activation (BA)
(and the optimal sequence of these elements) on depressive symptoms (PHQ-2 at
post treatment) in referred adolescents diagnosed with a depressive disorder.


Secondary Objective:
The secondary objective is to investigate the feasibility and effectiveness of
the CBT elements as judged by the clinicians and adolescents.

We will investigate the differential and sequential effects of the two
core elements of CBT, behavioral activation (BA) and cognitive restructuring
(CR), using a Single-Case Experimental Design (SCED; Smith, 2012). Such a
design uses repeated measurements to systematically investigate within-subject
differences to assess treatment outcomes. More specifically, this study will
use a replicated cross-over single case design (Vlaeyen et al., 2001).
This replicated cross-over single case design will last 12 weeks,
including a 3-week baseline period, a 6-week intervention period of the CBT
elements Cognitive Restructuring (CR) and Behavioral Activation (BA), and a
3-week follow-up period. All (N = 12) participants will be randomly assigned,
using computerized random assignment, to CR followed by BA (n = 6), or to BA
followed by CR (n = 6). CR and BA will both consist of three sessions, one per
week. By administering the two modular elements in a specific order, this study
design allows to establish the independent contribution of the CR and BA
elements

Measurements will be the same for all participants, i.e., in both
condition A (CR followed by BA) and B (BA followed by CR). There are three
types of assessments.
Diagnostic assessments will take place at the start of the 3-week baseline
period (T0); after the 3-week baseline period, right before the intervention
(T1); after the 3-week period of the first CBT-element (T2); post-intervention
assessment after the 3-week period of the second CBT-element (T3); after a
3-week period for follow up (T4). Both adolescent and their parent will
participate in these diagnostic measurements: digital questionnaires at all
assessment points (T0, T1, T2, T3 and T4), and a clinical interview at
assessment point T0 and T4 are conducted to investigate the presence of a
clinical depression disorder, symptom severity, measures of cognitions and
behavioral activation, and quality of life. These assessments consist partially
of measurements that are regularly distributed with CBT.
Daily assessments will take place throughout the entire 12-week study
period, in which only the adolescents will participate. Ten questions will be
asked once a day, at the end of the day, about the participant*s two core
depressive symptoms, most important personal problems, emotions, cognitions,
and behavior. These daily assessments will be completed on the adolescent*s
mobile phone, and take less than 5 minutes per day. The proposed daily
assessments will lead to 21 measurements per phase, which has been shown to be
sufficient for analysis (Vlaeyen et al., 2001).
By combining periodic diagnostic assessments with daily measurements,
SCED will allow for evaluation of the differential and sequential treatment
effects of BA and CR in two complementary ways. Treatment outcomes can be
assessed by descriptively comparing the diagnostic measurements at T0, T1, T2,
T3 and T4 within participants across time and across participants between
conditions. Similarly, patterns of daily depressive symptomatology, behavioral
activation, cognitions, emotions, top problems, and the passive behavioral
measurements can be descriptively and statistically compared across phases*the
baseline phase, first intervention phase, second intervention phase, and
post-intervention phase*both within individuals and between conditions.

The Cognitive Restructuring (CR) and Behavioral Activation (BA) modules come
from the STARr Training. STARr is developed and researched by researchers of
the Trimbos Instituut, Utrecht University and GGZ Oost Brabant in close
collaboration with certified CBT therapists and experts in the field. STARr is
developed based on current Dutch CBT-protocols (e.g., Doepressie and Op Volle
Kracht) and on MATCH-ADTC (Modular Approach to Therapy for Children with
Anxiety, Depression, Trauma, or Conduct Problems; Weisz et al., 2012). For this
Single Case study the modules have been adapted to an individualized format,
suitable for (severely) depressed adolescents. Each module consists of three
sessions, one per week, each one lasting 45 minutes.

The Cognitive Restructuring (CR) module aims to train adolescents to: identify
their own cognitions; understand the relation between events and their
cognitions, feelings, and behaviors; challenge unhealthy cognitions; create
new, healthier cognitions. Each of the three sessions, adolescents take a step
further in this learning process, according to the following content:
Session 1: psycho-education on (identifying) events, cognitions, feelings and
behavior
The first session consists of psycho-education and exercises regarding:
cognitions; basic emotions such as joy and anger, and more complicated
emotions; one*s behavior; how events, cognitions, feelings and behavior are
linked. Then automatic thought processes and the distinction between healthy
(helpful) and unhealthy (unhelpful) thoughts are introduced. Finally,
adolescents receive exercises to identify their own top three of helpful
thoughts/cognitions and assess their own event-thought-feeling-act patterns.
Session 2: challenging unhelpful cognitions.
In the second session, adolescents focus on understanding and identifying
unhealthy (unhelpful) thoughts/cognitions, such as catastrophic thoughts,
mind-reading thoughts, self-blame, and a negative self-bias. Thereafter
adolescents are explained how to challenge their unhelpful thoughts/cognitions,
by means of a 7-step approach: identify a set of a situation, unhelpful
thought, feeling and behavior; evaluate credibility of the unhelpful thought;
come up with arguments for and against their thought/cognition; focus on the
strongest argument against the unhelpful thought; come up with a
(counteractive) helpful thought; evaluate the credibility of this thought;
re-evaluate the credibility of the unhelpful thought. As a homework exercise
they will have to practice with this 7-step approach to challenge their
negative or unhelpful cognitions.
Session 3: learning how to challenge unhelpful cognitions in difficult
situations.
In this third and last session adolescents reflect on what they have learned so
far, and on how well they have been able to identify and challenge unhelpful
thoughts. In this session they have to explore events, thoughts, feelings and
behavior with regards to more ambiguous or complicated events, to further
practice the skills they have learned.

The Behavioral Activation (BA) module aims to educate adolescents on the
relationship between activity and behavior, and how to influence their
emotional wellbeing through behavioral activation.
Session 1: learning about the relation between acting and feeling.
The first session covers psychoeducation and exercises about the influence of
activities on one*s emotions. Adolescents will rate their emotions, link
activities to emotional experiences, and explore positive and negative spirals
of emotions and behavior influencing one another. Adolescents are explained how
to monitor their activities and their emotions, to become more aware of the
effects of their behavior on how they feel. This will be their homework
exercise.
Session 2: goal setting for behavioral activation.
After evaluation the feeling- and activity monitoring exercise, adolescents
reflect on their own positive and negative spirals. Thereafter, they explore
the possible causes of negative spirals, think of ways to enhance their
positive spirals, and set goals to improve their mood.
Session 3: evaluation of behavioral activation and goals.
Adolescents evaluate their monitoring results of the past two weeks, to see if
things have changed, if they have achieved their goals, and if they want to set
new goals. They receive tips for fun things to do and evaluate the exercises.

Risks are expected to be the same as in regular Cognitive Behavioural Therapy.
Regular CBT provides 12 to 15 sessions that involve cognitive restructuring
(CR), behavioral activation (BA), relaxation, and training of problem-solving
skills. In the current study we will administer three sessions of CR and three
sessions of BA. Participants will either receive the three sessions of CR first
followed by the three sessions of BA, or vice versa. After participating in the
study, participants have the opportunity to follow the other CBT modules
(relaxation, and training of problem-solving skills). The extra burden on
clients for participating in this study is: filling out five times a digital
questionnaire (40-65 minutes each), two times a structured interview (K-SADS,
45-90 minutes each), and 84 daily questionnaires (5 minutes each). In total,
this requires approximately, on average, 13,5 hours extra from clients who
participate in the study. See Table 2 in the protocol for an overview of the
extra burden of questionnaires on the participants. A major benefit for the
participant is that all questionnaires provide additional information/input for
the CBT treatment. Therefore, participating in the study provides an advantage
for the participants as well as the provided CBT. As suicide risk and
depression are tightly monitored we expect the study design to reduce
participants* chances of committing suicide. Because the additional information
provides substantial benefits for monitoring and distributing the CBT modules,
the burden on participants is not expected to be higher.can contribute to plan
further treatment.*