Process and Outcomes in CBT for Anxious and Depressed Youth

NCT03100279 | Unknown

• 1 other identifier: 05-504Rc11
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression

Keywords

cognitive behavioral therapy; treatment mediators; trajectories of change

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Global Impression - Severity (CGI-S) Scale: interviewer

  The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment.

  Change from pre-treatment to post-treatment (an average of 16 weeks)

Secondary Outcomes (40)

• Change in Anxiety Disorders Interview Schedule (ADIS-IV) - Principal Diagnosis

  Change from pre-treatment to post-treatment (an average of 16 weeks)

• Change in Children's Depression Rating Scale-Revised (CDRS-R): Total depression score

  Change from pre-treatment to post-treatment (an average of 16 weeks)

• Change in Strengths and Difficulties Questionnaire total impairment - parent report

  Change from pre-treatment to post-treatment (an average of 16 weeks)

• Change in Strengths and Difficulties Questionnaire total impairment - child report

  Change from pre-treatment to post-treatment (an average of 16 weeks)

• Change in State-Trait Anxiety Inventory for Children (STAIC) - Trait Scale: parent

  Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks)

Study Arms (1)

CBT for Anxiety or Depression

EXPERIMENTAL

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.

Behavioral: Coping Cat/CAT Project; Behavioral: Primary and Secondary Coping Enhancement Therapy

Interventions

Coping Cat/CAT Project 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.

CBT for Anxiety or Depression

Primary and Secondary Coping Enhancement Therapy 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.

CBT for Anxiety or Depression

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers University: lead

Study Sites (1)

Rutgers University (Youth Anxiety and Depression Clinic)

Piscataway, New Jersey, 08854, United States

RECRUITING

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MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Brian C Chu, Ph.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian C Chu, Ph.D.

CONTACT

848-445-4903; brianchu@gsapp.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 4, 2017
• Study Start: July 1, 2005
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)