Process and Outcomes in CBT for Anxious and Depressed Youth

NCT ID: NCT03100279

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-01
• Study Completion Date: 2022-08-31

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.

Conditions

Anxiety Disorders; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT for Anxiety or Depression

If a youth meets criteria for a primary diagnosis of clinical or subclinical depressive disorder she or he will be assigned to Primary and Secondary Control Enhancement Therapy (PASCET; Weisz et al., 1987). If a youth meets criteria for a primary diagnosis for a clinical or subclinical anxiety disorder, she or he will be assigned to the Coping Cat (Kendall, 2000). Both CBT treatments include a therapist manual and companion workbooks for the youth. CBT teaches coping skills that help anxious and depressed youth challenge anxious and depressive thinking. It also helps the child habituate to negative physiological feelings and learn skills to cope with emotional distress.

Group Type: EXPERIMENTAL

Coping Cat/CAT Project

Intervention Type: BEHAVIORAL

The "Coping Cat" program, developed by Kendall and colleagues (Kendall, 1994; Kendall, 2000; Kendall, Kane, Howard, \& Siqueland, 1989; Kendall, Flannery-Schroeder et al., 1997), involves (1) teaching children to identify their own anxious feelings and physiological signs of anxiety, (2) teaching children to identify their own anxiety-provoking cognitions, (3) developing a plan to guide coping - a plan that involves changing the child's thoughts (into positive self-talk) and actions (into self-initiated exposures), and (4) self-evaluation and self-reward. The therapist uses modeling (e.g., revealing therapist's own anxiety and sharing successful coping experiences), in vivo exposure tasks, role-playing (e.g., to prepare for exposure tasks), relaxation training, and contingent reinforcement (e.g., for trying and for succeeding at exposure tasks), in developing these four themes.

Primary and Secondary Coping Enhancement Therapy

Intervention Type: BEHAVIORAL

PASCET is a brief (11-15 sessions) CBT program for depressed youths typically aged 8-15. Sessions and practice assignments are built on findings concerning cognitive and behavioral features of youth depression (e.g., Lewinsohn et al., 1990; Stark et al., 1987), and on the two-process model of perceived control and coping (Rothbaum, Weisz, \& Snyder, 1982; Weisz et al., 1984a,b). In this model, primary control involves efforts to cope by making objective conditions (e.g., one's activities, one's peer status) conform to one's wishes. In contrast, secondary control involves coping by adjusting oneself (e.g., one's expectations, interpretations) to fit objective conditions, so as to influence their subjective impact without altering the actual conditions. The goal is for youngsters to build their skills in primary and secondary control coping, and apply those skills to events and conditions that can trigger depression. Therapists are guided by a Therapist's Manual and use a youth workbook.

Interventions

Coping Cat/CAT Project

The "Coping Cat" program, developed by Kendall and colleagues (Kendall, 1994; Kendall, 2000; Kendall, Kane, Howard, \& Siqueland, 1989; Kendall, Flannery-Schroeder et al., 1997), involves (1) teaching children to identify their own anxious feelings and physiological signs of anxiety, (2) teaching children to identify their own anxiety-provoking cognitions, (3) developing a plan to guide coping - a plan that involves changing the child's thoughts (into positive self-talk) and actions (into self-initiated exposures), and (4) self-evaluation and self-reward. The therapist uses modeling (e.g., revealing therapist's own anxiety and sharing successful coping experiences), in vivo exposure tasks, role-playing (e.g., to prepare for exposure tasks), relaxation training, and contingent reinforcement (e.g., for trying and for succeeding at exposure tasks), in developing these four themes.

Intervention Type: BEHAVIORAL

Primary and Secondary Coping Enhancement Therapy

PASCET is a brief (11-15 sessions) CBT program for depressed youths typically aged 8-15. Sessions and practice assignments are built on findings concerning cognitive and behavioral features of youth depression (e.g., Lewinsohn et al., 1990; Stark et al., 1987), and on the two-process model of perceived control and coping (Rothbaum, Weisz, \& Snyder, 1982; Weisz et al., 1984a,b). In this model, primary control involves efforts to cope by making objective conditions (e.g., one's activities, one's peer status) conform to one's wishes. In contrast, secondary control involves coping by adjusting oneself (e.g., one's expectations, interpretations) to fit objective conditions, so as to influence their subjective impact without altering the actual conditions. The goal is for youngsters to build their skills in primary and secondary control coping, and apply those skills to events and conditions that can trigger depression. Therapists are guided by a Therapist's Manual and use a youth workbook.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers University

OTHER

Sponsor Role: lead

Responsible Party

Brian Chu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian C Chu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Rutgers University (Youth Anxiety and Depression Clinic)

Piscataway, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brian C Chu, Ph.D.

Role: CONTACT

brianchu@gsapp.rutgers.edu

848-445-4903

Facility Contacts

Brian Chu, Ph.D.

Role: primary

brianchu@gsapp.rutgers.edu

848-445-3903

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Other Identifiers

05-504Rc11

Identifier Type: -

Identifier Source: org_study_id