Unified Protocol for Adolescents (UP-A) Change Processes

The goal of this study is to examine how a core dysfunction transdiagnostic psychotherapy for
emotional disorders in youth influences change in cross-cutting features both theoretically
linked to neuroticism and also targeted by this treatment. Another goal is to investigate
change in symptoms of emotional disorders, including anxiety and depression, throughout the
course of this treatment, the Unified Protocol for the Treatment of Emotional Disorders in
Adolescents (UP-A).

My long-term goal is to identify ways to personalize an effective psychotherapy model for an
array of youth emotional disorders by determining how and when implementation of different
components of the UP-A influence change in mental health. My research objective in this study
is to use group-level and novel single case analytic strategies to identify changes in
emotional disorders during the implementation of the UP-A, a transdiagnostic form of
cognitive behavior therapy (CBT) for adolescents. Specifically, I am interested in examining
how features of the core dysfunction targeted by the UP-A, high neuroticism as well as
symptoms of emotional disorders change throughout UP-A treatment. My central hypothesis is
that adolescents with emotional disorders will display changes in measures of core
dysfunction and reductions in symptoms of emotional disorders throughout UP-A treatment.

Aim 1: Investigate relationships between the use of UP-A treatment components and changes in
measures of neuroticism, a core dysfunction that cuts across of emotional disorders. The main
working hypothesis is that the administration of the UP-A will result in observable changes
in measures of cross-cutting features of emotional disorders linked to neuroticism (cognitive
flexibility, distress tolerance, and experiential avoidance). Such changes will occur after
the introduction of relevant core principles of the UP-A. The proposed study is designed to
determine whether change in these aspects of neuroticism and emotional disorder symptoms
occur directly following the presentation of treatment components, or whether changes might
instead be staggered throughout treatment.

Aim 2: Investigate when and how reductions in symptoms of emotional disorders (i.e., symptoms
of anxiety and depression, severity of presenting problems) occur throughout treatment. Based
on knowledge obtained from previous randomized, controlled trials (RCTs) focusing on the
treatment of anxiety, depressive and related disorders, the main working hypothesis of Aim 2
is that the severity of emotional disorder symptoms will decrease from pre- to
post-treatment.

Exploratory Aim 3: Investigate aspects of neuroticism as potential mechanisms of change in
emotional disorder symptoms. The primary working hypothesis of Aim 3 is that changes in
features of neuroticism targeted by the UP-A will precede changes in anxiety and depressive
symptoms.

RESEARCH STRATEGY A. SIGNIFICANCE Anxiety, depression, and related emotional disorders are
prevalent and impairing. They have high levels of symptom overlap and also share underlying
temperament factors, including high neuroticism and low extroversion. The UP-A and similar
core dysfunction-focused transdiagnostic therapy approaches may lead to successful treatment
by targeting features that cut across emotional disorders.

B. INNOVATION Several studies of the UP-A indicate significant improvements in both anxiety
and depression from pre- to post-treatment. Research foci have recently shifted in an effort
to figure out why such these core-dysfunction treatments work. One step in this direction is
determining whether cross-cutting features defining internalizing disorders (i.e.,
neuroticism and related constructs) might serve as mechanisms of treatment-based change in
disorder symptoms and severity. One case study using the adult UP treatment found that
changes in cross-cutting features, including mindfulness and cognitive reappraisal, changed
prior to reductions in anxiety and depression. Within the child literature, a downward
adaptation of the UP-A (as compared to anxiety-focused CBT program) demonstrated greater
decreases in several cross-cutting features of emotional disorders, including sadness
dysregulation and reappraisal, over the course of treatment. However, no study thus far has
investigated change processes in cross-cutting features of emotional disorders, during
treatment with the UP-A. The present study will advance our understanding of how
implementation of the UP-A might lead to change in direct cognitive and behavioral targets as
well as symptoms of emotional disorders in adolescents. An increased understanding of how,
when and for whom the UP-A works is vital to personalizing this psychotherapy and maximizing
its efficiency and uptake in future dissemination and implementation research. Another
innovation of this investigation is its novel application of single-case research design
methodology and modeling techniques in the analysis of time-sequence data. Although
mechanisms of change may be investigated via large-scale RCTs of clinical interventions, the
time, cost and labor of such trials can impede rapid dissemination efforts. This innovative
single-case methodology allows clinical researchers to vet potential mechanisms of change
more quickly to be used in future research.

C. APPROACH Research Design and Methods Overview. A non-concurrent multiple baseline design
will be used. This type of design includes a series of A-B replications along with randomly
assigned baseline periods (2, 3, or 4 weeks in this study; 3 participants per baseline
condition). Repeated measures (adolescent- and parent-report of changes in cross-cutting
features of emotional disorders and of disorder-specific symptoms) will be given weekly
throughout treatment with more comprehensive assessment (adolescent- and parent-report as
well as clinician-rated clinical severity and diagnostic impressions) occurring at pre- and
post-treatment time points. The specific combination of analyses being used (nonparametric
group-level comparisons to assess change at major time points [pre-, mid-, and
post-treatment] as well as Simulation Modeling Analysis [SMA] to assess change over time in
an individual) requires measures to be administered at a variety of time points (i.e., pre-
and post- treatment, pre-, mid-, and post-treatment; weekly, respectively). Thus, change over
time in weekly measures will be examined at pre-, mid-, and post-treatment at a group level,
while change over time in weekly measures will be examined using weekly data (baseline,
treatment repeated measures) at an individual subject level. Further, change over time in
clinical interview data will be assessed from pre- to post-treatment.

Participants. A minimum of nine clinically anxious and/or depressed adolescents between the
ages of 13 and 17 will be recruited via a university clinic, with at least three adolescents
randomized to each baseline condition.

Intervention. Unified Protocol for the Treatment of Emotional Disorders in Adolescents
(UP-A). Adolescents will complete 16 sessions of the Unified Protocol for the Treatment of
Emotional Disorders in Adolescents in a fixed order. The UP-A is composed of 8 core modules,
including Orienting to Treatment and Enhancing Motivation, Emotion Education, Introduction to
Emotion-focused Behavioral Experiments, Awareness of Physical Sensations, Being Flexible in
Your Thinking, Emotional Awareness, Situation-Based Emotion Exposures, Relapse Prevention.

Analytic Plan Data will be analyzed using a specific combination of analyses supported in the
single case research design and clinical replication literature. Initial approaches will
utilize data from weekly measures, plus those administered at pre-treatment, post-baseline,
mid-treatment, and post-treatment time points. A second group of analyses, which will be used
to measure change over time in variables of interest throughout treatment as well as
potential mechanisms of treatment change, include the application of Parker and Hagan-Burke's
(2007) clinical outcomes approach, which was established specifically for the analysis of
single-case data as well as Simulation Modeling Analyses (SMA; [1-3, 30]), to identify
changes in cross-cutting features and emotional disorder symptoms over the course of
implementation of the UP-A.

Inclusion Criteria:

- Adolescents must be between 13 and 17 years of age

- Adolescents must have a primary DSM-5 anxiety or depressive disorder based on results
of a diagnostic interview administered by a trained clinician at intake within
protocol 20130139

- Adolescents must indicate elevated symptoms of depression via adolescent and/or parent
report of symptoms (RCADS and/or RCADS-P Depression Subscale Index T-Score ≥ 60) and
anxiety (RCADS and/or RCADS-P Total Anxiety Subscale Index T-Score ≥ 60) at intake

- If relevant, adolescents must be on a stable dose of any SSRI/SNRI medication

- Adolescents must self-report the ability to speak/read English sufficiently (and have
at least one parent who can) to complete all study measures in English

- Adolescents must have a legal guardian available to sign study consents, remain
present during assessments, and fill out study questionnaires.

Exclusion Criteria:

- Adolescents obtain a Full Scale IQ score below 80 on the Vocabulary and Matrix
Reasoning subtests of an abbreviated IQ test

- Adolescents indicate possible cognitive delays that could interfere with successful
completion of study procedures

- Adolescents currently receiving psychotherapy elsewhere.