Clinical trial NCT03100279: Process and Outcomes in CBT for Anxious and Depressed Youth
Official title: Psychotherapy Process and Outcomes in Cognitive-Behavioral Treatment for Anxious and Depressed Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Depression
Keywords: cognitive behavioral therapy
treatment mediators
trajectories of change
Lead sponsor: Rutgers University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study will employ a quasi-experimental open-trial design that includes a comprehensive diagnostic assessments at pre- and post-treatment (diagnostic interview, symptom and functioning measures, and prospective mediators) and continuous assessment throughout an active treatment phase. Anxiety/depression symptoms will be assessed each session and prospective mediators (cognitive, behavioral, and affective variables) will be assessed every four sessions. A two-week baseline period will separate the initial intake from the first treatment session. The traditional ABAB experimental single-case design will not be used because it is not appropriate in clinical situations where the removal of treatment intervention could be harmful to clinical patients (Kazdin, 1992). Each youth who meets inclusion criteria will complete a two-week baseline phase that includes three assessments (intake, phone follow-up, and first session).
Primary purpose: TREATMENT

Brief summary: The current study will evaluate the predictors, mediators, outcomes, and critical therapy processes associated with manual-based psychological therapies for 400 youth (ages 7-16 years) with anxiety and/or depression seeking services within a semi-natural clinic setting. Essentially, this study seeks to determine "what works" about psychological therapy for youth.

Detailed description: The current study will evaluate the efficacy of manual-based psychological therapies administered with youth with anxiety and mood problems. It will also assess the role of several mediators (e.g., coping skills, negative self-statements, parenting practices) hypothesized to maintain youth anxiety and depression. Youth (ages 7 - 16) diagnosed with a principal Anxiety or Depressive Disorder will be recruited to receive Cognitive-Behavioral Therapy (CBT). Anxiety (e.g., Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia) and depressive disorders (e.g., Major Depression Disorder, Dysthymia Disorder) are among the most common emotional disorder affecting America's youth, with 12-20% of youth meeting criteria for an anxiety disorder and 2-5% meeting criteria for depression at any one point in time. Both forms of disorders are associated with significant distress and functional impairment in school, peer, and family domains. Left untreated, early affliction with these disorders leaves individuals at risk for adult anxiety disorders, chronic depression, substance abuse, and long-term functional impairment. Identifying efficacious treatments and their most effective, "active ingredients" is a top health research priority. In addition, knowledge about how our psychotherapies work lags behind research documenting simple treatment effects. Knowing the therapy techniques that have the best outcomes as well as knowing how those interventions produce gains will provide valuable information for improving our already effective therapies.

Two manual-based psychological treatments that have received empirical support in clinical trial outcome studies are cognitive-behavioral treatment for anxious children (Kendall's Coping Cat) and cognitive-behavioral treatment for depressed children (Weisz's PASCET). Both treatments (a) use a manual and (b) have been supported in clinical trial outcome studies where youth receiving the manualized treatment interventions improve more than the control groups. The Kendall treatment program has produced some of the strongest treatment effects yet seen in the empirical literature for children and adolescents.

Despite our increasing knowledge of treatments that work, there has been insufficient analysis of psychological mediators in youth psychotherapy. Research on psychological mediators, or "mechanisms of action," provide information about how psychotherapy works. Randomized clinical trials document that CBT produces clinical outcomes, such as decreased symptoms and impairment following treatment. Fewer studies have assessed the degree to which coping skills, emotion management, or cognitive restructuring mediate these clinical gains. This type of mediator analysis is essential to test the theory underlying our treatments and helps inform our models of pathology. For example, if increased primary (active) coping skills precede a reduction in depressive symptoms, we might infer that poor coping skills are a maintaining factor of depression and that successful therapy works by increasing a youth's use of such skills.

In the current study, we will invite youth to participate in a CBT intervention with demonstrated efficacy and will conduct a thorough assessment of potential therapy process and mediator variables that impact treatment outcomes. Both primary (active problem solving) and secondary (attempts to adjust to situations that can not be changed) coping skills have been linked to a number of psychological distress states in youth and may have specific links to maintaining depression in youth. In anxious youth, the ratio of negative to positive self-talk has been shown to mediate gains in CBT. The role of parenting practices has also been highlighted as an important maintaining factor in anxiety (e.g., modeled anxious behavior, parent intrusiveness). Self-efficacy, a cognitive appraisal of one's ability to manage challenges, has also been related to distress in youth. Affective components, such as positive affect, negative affect, and physiological hyperarousal have received increased attention because of they reflect basic emotional processes that underlie and distinguish anxiety and depressive disorders. Finally, less research has identified cognitive functioning related to anxiety and depression, but experts encourage the assessment of multidimensional cognitive factors in the expression of psychological distress to enhance our ability to factor in normative developmental processes. Given this, the current study will assess youth primary and secondary coping skills, youth automatic thoughts and self-statements, parenting practices, affective processes and cognitive functioning as treatment outcomes and potential mediators of symptom change in CBT.

There have also only been minimal attempts to explore the therapist and client factors that impact within-session therapy processes that could improve the delivery of our empirically-supported treatments. Process factors like client engagement and therapeutic alliance may deserve particular attention in youth-based therapies because youth rarely refer themselves for treatment, often do not recognize or acknowledge the existence of problems, and frequently are at odds with their parents about the goals of therapy. Recent empirical data suggests that youth demonstrating greater engagement or stronger therapeutic alliance may experience better treatment outcomes. Therapist responsiveness to child needs and flexibility in implementing manual-based therapies might also have significant, if indirect, effects on successful treatment. A greater understanding of therapist, child, and interpersonal factors that improve the delivery of therapy could lead to concrete recommendations in training novice clinicians or in developing improved versions of current therapy manuals.

Because treatment will occur within a semi-natural clinic setting, a multiple baseline, single-case design will be used. Employing a single-case design in this context will permit continuous assessment throughout baseline and treatment phases. This design will provide data for the course and sequence of symptom and mediator change. We will also be able to document the sequence of symptom change as it relates to the introduction of specific treatment interventions. The combined information can provide valuable information for how these treatments work and which interventions produce what specific client change.

II. SPECIFIC AIMS

The current study will attempt to address the following aims:

Aim 1. Determine whether CBT for anxiety and depression are effective in a natural clinic setting where cases exhibit greater range of symptom severity, multiple clinical problems, and greater socioeconomic and cultural diversity. Effectiveness will be assessed in diagnostic, symptom, and adaptive functioning domains, including executive cognitive functioning.

Aim 2. Determine if youth coping skills, behavioral activation, automatic thoughts, affective process, self-efficacy or parenting practices mediate the relationship between CBT interventions and clinical outcomes.

Aim 3. Determine if youth or therapist within-session processes (e.g., child involvement, therapeutic alliance, therapist adherence to treatment protocol) moderates treatment success.

Aim 4. Determine the pattern of symptom change associated with CBT for youth (e.g., gradual symptom decline, presence of sudden gains).

Aim 5. Note patterns of additional youth mental health services and auxiliary services that families seek beyond treatment received at the Youth Anxiety and Depression Clinic.

Eligibility criteria: Inclusion Criteria:

We expect 200 youth (ages 7-16 years) with a primary anxiety disorder and 200 youth (ages 7 - 16 years) with a primary depressive disorder to serve as participants. To participate, a youth must meet criteria for a primary DSM-IV-TR (American Psychiatric Association, 2000) diagnosis of Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Specific Phobia, Panic Disorder with or without a history of Agoraphobia, Major Depression Disorder, Minor Depression, or Dysthymia. Diagnosis will be based on both youth and parent report during an Independent Evaluator (IE) semi-structured interview. Youth may also participate with a subclinical diagnosis for any of these disorders if: (a) the youth demonstrates sufficient symptoms but does not yet reach clinical levels of impairment OR (b) the youth demonstrates only several symptoms related to the above disorders but demonstrates clinical impairment, AND (c) the consenting parent agrees that anxiety or mood problems would be appropriate as a clinical focus for treatment. Allowing youth with subclinical diagnoses will allow the study to investigate the effectiveness of the therapies across a range of clinical severity. This design models usual community care where a larger range of severity is witnessed and many youth may not meet all criteria for formal diagnosis. After receiving an initial diagnostic assessment, the parent must consent and the youth must assent to continued participation in the study and must be willing to receive psychological therapy at the Youth Anxiety and Depression Clinic (YAD-C), a specialty program within the outpatient clinic of the Rutgers University Graduate School of Applied and Professional Psychology (GSAPP).

Exclusion Criteria:

Youth who have a primary diagnosis of a DSM-IV disorder other than anxiety or depression (e.g., anorexia nervosa, Postraumatic Stress Disorder, Attention Deficit-Hyperactivity Disorder), or who have received any diagnosis of mental retardation, a pervasive developmental disorder, schizophrenia, or bipolar disorder will be excluded. Youth who demonstrate suicidal ideation or intent (by child or parent report) severe enough to require current hospitalization, or youth who have attempted suicide in the past 3 months, will also be excluded. These clinical problems require specialized treatment that YAD-C is not prepared to offer.

Primary outcomes:
measure: Change in Clinical Global Impression - Severity (CGI-S) Scale: interviewer
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
Secondary outcomes:
measure: Change in Anxiety Disorders Interview Schedule (ADIS-IV) - Principal Diagnosis
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Children's Depression Rating Scale-Revised (CDRS-R): Total depression score
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Strengths and Difficulties Questionnaire total impairment - parent report
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Strengths and Difficulties Questionnaire total impairment - child report
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in State-Trait Anxiety Inventory for Children (STAIC) - Trait Scale: parent
timeFrame: Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks)
measure: Change in State-Trait Anxiety Inventory for Children (STAIC) - Trait Scale: child
timeFrame: Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks)
measure: Change in Revised Children's Anxiety and Depression Scale (RCADS) - Parent
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Revised Children's Anxiety and Depression Scale (RCADS) - depression subscale
timeFrame: Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks)
measure: Change in Multidimensional Anxiety Scale for Children - Child
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Multidimensional Anxiety Scale for Children - Parent
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Multidimensional Anxiety Scale for Children - Brief form
timeFrame: Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks)
measure: Change in Center for Epidemiologic Studies-Depression Scale (CES-D) - Child
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Center for Epidemiologic Studies-Depression Scale (CES-D) - Parent
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Adolescent Alcohol and Drug Involvement Scale (AADIS): incidents of substance abuse
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Olweus Bully/Victim Questionnaire - Parent and Child report (OBVQ-P/C): frequency of victimization events
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Multidimensional Bullying Impact Scale (MBIS) - total impairment score
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Child Behavior Checklist (CBCL) - total internalizing score
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Child Behavior Checklist (CBCL) - total externalizing score
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Responses to Stress Questionnaire (RSQ)-Youth
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Responses to Stress Questionnaire (RSQ)- Parent
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Behavioral Activation for Depression Scale - Adolescent (BADS-A); youth
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Behavioral Activation for Depression Scale - Adolescent (BADS-A); parent forms
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Child Automatic Thoughts Scale: child report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Affect and Arousal Scale: child report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Difficulties in Emotion Regulation Scale: child report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Real-time Emotion Action and Cognition Tracker (REACT) system: child
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Rearing Behaviors Questionnaire: child
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Rearing Behaviors Questionnaire: parent
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Family Environment Scale - parent and child
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Me and My Mother (MMM): child report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Me and My Father (MMF): child report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Depression Anxiety Stress Scales-21 (DASS-21) - parent
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Parent-Child Interaction Questionnaire (PCIQ) - parent report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Parental Acceptance and Action Questionnaire (PAAQ) - parent report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Stroop Color-Word Association Test error score: child
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Emotional Stroop error score: child
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
measure: Change in Therapeutic Alliance Scale for Children/Adolescents - therapist report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Therapeutic Alliance Scale for Children/Adolescents - child
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Child Involvement Rating Scale-Therapist report
timeFrame: Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks)
measure: Change in Service Assessment for Children and Adolescents (SACA) - Service Use Scale: parent report
timeFrame: Change from pre-treatment to post-treatment (an average of 16 weeks)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University (Youth Anxiety and Depression Clinic)
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Brian C Chu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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