Unified Protocol for Adolescents (UP-A) Change Processes
Condition: Anxiety Disorders; Depression; Obsessive-Compulsive Disorder; Adolescent - Emotional Problem; Emotional Disorder
MeSH terms: Anxiety Disorders; Obsessive-Compulsive Disorder; Mood Disorders
Study type: Interventional

Summary: 
      The purpose of this protocol is to employ single case analytic strategies, including a
      multiple baseline design and novel modeling techniques to identify changes in cross-cutting
      features of emotional disorders as well as emotional disorder symptoms during the
      implementation of The Unified Protocol for the Treatment of Emotional Disorders in
      Adolescents (UP-A). The first aim is to investigate relationships between the use of UP-A
      treatment components and changes in measures of cross-cutting features of emotional
      disorders. The second aim is to investigate when and how reductions in symptoms of emotional
      disorders and presenting problems (i.e., symptoms of anxiety and depression, severity of
      presenting problems) occur throughout treatment.
    

Detailed description: 
      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.
    

Intervention name(s): Unified Protocol for Emotional Disorders in Adolescents (UP-A)
Intervention type(s): Behavioral
Intervention description(s): The Unified Protocol for Emotional Disorders in Adolescents (UP-A), is a transdiagnostic therapeutic intervention employing core dysfunction approaches, defined as such due to their attendance to features of various (emotional) disorders. The treatment may work to ameliorate symptoms more broadly by targeting cross-cutting features common to the range of disorders targeted. Specifically, the UP-A might lead to the successful treatment of an array of emotional disorders in youth by targeting processes common across these frequently co-occurring problems including poor distress tolerance, limited cognitive flexibility, and heightened avoidance.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomly assigned to one of three baseline conditions (2, 3, or 4 week waitlist) and all participants are subsequently treated using the active study intervention (UP-A).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transdiagnostic Treatment; Emotional Disorders; Adolescence; Psychotherapy