Transdiagnostic Individual Behavioral Activation and Exposure Therapy

Depression Clinical Trial

Official title:

Randomized Clinical Trial of Transdiagnostic Behavioral Activation and Exposure Therapy for Youth: A Comparison of Effects and Mediators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03412227
• Other study ID #: Pro20170001171
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 31, 2025

Study information

• Verified date: November 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Brian C Chu, Ph.D.
• Phone: 848-445-3905
• Email: yadc[@]gsapp.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Overall Aim of the this project is to compare treatment outcomes and change in putative treatment mediators in Individual Behavioral Activation Therapy (IBAT) against two active psychological interventions (Coping Cat, PASCET) and a wait-list control. Participants will be 200 youth (ages 9-17) diagnosed with a principal anxiety or depression disorder and their caregivers.

Description:

Anxiety and unipolar depression are highly debilitating and commonly co-occurring in young adolescents with lifetime prevalence rates estimated at 8.4% for major depression or dysthymia and at 31.4% for any anxiety disorder in youth ages 13-14 (Merikangas et al., 2010). Cognitive and behavioral therapies (CBT) have received strong support for reducing distress in youth (Silverman, Pina, & Viswesvaran, 2008; David-Ferdon & Kaslow, 2008), but efficacy rates peak around 50-70% for anxiety and less for depression. Evidence is accumulating that "transdiagnostic" behavioral therapies that address multiple problems at the same time can enhance treatment outcomes by targeting the mechanisms that underlie commonly co-occurring problems, like anxiety and depression (Chu, Temkin, & Toffey, 2016; Temkin, Yadegar, Laurine, & Chu, in press). Furthermore, consolidated transdiagnostic treatment protocols can provide the same level of clinical benefit while delivering active components in a more efficient package, which can increase treatment efficiency and potentially make it easier to train novice clinicians in the future (Chu, 2012; Ehrenreich & Chu, 2013). While the evidence-base is growing for adult conditions, transdiagnostic interventions have been examined less in child and adolescent populations. Our team has demonstrated the efficacy of a school-based group transdiagnostic intervention that made use of behavioral activation (BA) and exposure therapy to address anxiety and depression for middle-school youth (Chu, Crocco, Esseling, Areizaga, Lindner, & Skriner, 2016). BA refers to a set of interventions that teach youth how to assess which stressors trigger avoidant coping responses in their lives (i.e., functional assessment) and learn how to address problems with pro-active problem solving strategies. Exposure therapy refers to a set of behavioral interventions that foster new learning tendencies by encouraging and reinforcing contact with the situations that scare individuals. Both sets of strategies have received substantial support in treating youth anxiety and depression. The Chu et al., (2016) trial demonstrated that these two treatment components could be combined and effectively treat a sample of youth reporting either anxiety or depression.

The Chu et al. (2016) study was novel because most forms of evidence-based treatment have been designed as "single disorder" protocols, such that the interventions were designed to target one clinical problem at a time. The current trial takes the following innovative steps. The study will: (a) adapt the Chu et al. group-based protocol to an individual format, (b) deliver the program in a clinical outpatient setting, and (c) utilize three comparison conditions, including a wait-list control and two active psychological interventions. The two active interventions will be single disorder cognitive behavioral therapies (CBT) that were designed to specifically address either youth depression (Primary and Secondary Control Enhancement Therapy; PASCET; Weisz, Thurber, Sweeney, Proffitt, & LeGagnoux, 1997) or youth anxiety (Coping Cat; Kendall, 1994; Kendall et al., 1997). Both have received substantial support in the literature for supporting clinical improvements in brief individual formats (12 - 16 weeks). By comparing Individual Behavioral Activation Therapy (IBAT) to each of these active interventions, the study aims to demonstrate (a) superior treatment outcomes to wait-list control, (b) comparable treatment outcomes to PASCET and Coping Cat, and (c) differential mediator effects across the four conditions. Findings will provide support for the feasibility, acceptability, and efficacy of IBAT and provide conceptual support for its purported mediators of change.

The current study is a Randomized Controlled Trial (RCT), comparing a novel behavioral intervention (Individual Behavioral Activation Therapy, IBAT) against two established cognitive-behavioral interventions (Coping Cat, PASCET) and a 14-week waitlist (WL) control. Participants will be 160 youth (ages 9-16 years old) who receive a diagnosis of a Diagnostic and Statistical Manual - 5th edition (DSM-5; APA, 2013) anxiety or depression disorder and their caregivers. Participants will be randomly assigned evenly to each of four conditions. The study intends to recruit participants within a 2.5-year period and complete all active participant participation within 3 years.

Specific aims include the following:

Aim 1 - Treatment Efficacy: To evaluate differences in treatment outcomes across IBAT, PASCET, CC, and WL conditions across pre-, mid-, and post-treatment in treatment efficacy, focusing on key diagnostic and symptom outcomes (i.e., CGI, principal diagnosis presence to absence and clinical severity, RCADS anxiety and depression scores, MASC, CESD).

Hypothesis 1: IBAT will produce superior outcomes to 14-week WL control

Hypothesis 2: The three active treatment conditions (IBAT, PASCET, CC) will demonstrate superior treatment outcomes to 14-week WL control, but will not be different from each other.

Aim 2 - Mediator Analysis: To examine the strength of putative mediators in explaining the effects of active treatments (IBAT, CC, PASCET) in comparison to the 14-week WL and in comparison to each other. Putative mediators will include multiple domains: (a) youth socio-emotional functioning (cognitive, behavioral, and affective responses), (b) distress tolerance as assessed by computer tasks, (c) family environment and interactions, (d) caregiver distress and functioning, (e) client and therapist perception of psychotherapy process, (f) ecological momentary assessment and passive sensor data.

Hypothesis 3: Each domain will prove to provide significant mediators for each treatment in comparison to the WL control.

Hypothesis 4: Cognitive mediators will prove to provide significant mediation of CC and PASCET treatment effects, but not necessarily for IBAT.

Hypothesis 5: Distress tolerance will prove to provide significant mediator for IBAT treatment effects, but not necessarily for CC or PASCET.

Aim 3. Note patterns of additional youth mental health services and auxiliary services that families seek beyond treatment received at the Youth Anxiety and Depression Clinic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

We expect 200 youth (ages 9-17 years) with either a principle anxiety (n=100) or a unipolar depression disorder (n=100) and their parents/caregivers to serve as participants.

Inclusion Criteria:

To participate, a youth must meet criteria for a primary DSM-5 (American Psychiatric Association, 2003) diagnosis of any of the following:

• Generalized Anxiety Disorder (GAD)

• Separation Anxiety Disorder (SEP)

• Social Anxiety Disorder (SAD)

• Specific Phobia (SP)

• Panic Disorder (PD)

• Agoraphobia

• Major Depression Disorder (MDD)

• Depression Disorder - Insufficient Symptoms (DD-Insufficient)

• Persistent Depressive Disorder (PDD)

Comorbid (non-principal) disorders are acceptable, including the presence of disorders not listed above. 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 at T1, the parent must consent and the youth must assent to continued participation in the study, including randomization to treatment condition, 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 principal DSM-5 disorder other than one of the above listed anxiety or depression disorders (e.g., anorexia nervosa, Post-traumatic Stress Disorder, Attention Deficit-Hyperactivity Disorder), or who have received any diagnosis of:

• Intellectual Disability

• Autism Spectrum Disorder

• schizophrenia

• bipolar disorder.

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. Youth will not be excluded on the basis of gender or racial/ethnic origin. However, youth and at least one parent will be required to speak English sufficiently enough to complete study procedures and surveys in English. Participants will be asked not to engage in any other outpatient psychological treatment during their time in the study; this is important to enhance internal validity of the study and conforms with best clinical practices to avoid conflicting treatment recommendations. However, current use of antidepressant or anxiolytic medications will NOT be an exclusion. Participants will be asked to arrive at a stable dosage and schedule for their medication, in consultation with their presiding physician or psychiatrist, prior to study initiation. Use of medications and any other treatment modalities will be assessed during study participation and compared across treatment and WL conditions.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

Behavioral:
• Individual Behavioral Activation Therapy (IBAT)
IBAT is a manual-based, individual behavioral activation plus exposure therapy aimed at treating youth with anxiety, depression, and anger. The program consists of 10-14 weekly 60 minute sessions. It uses behavioral activation (BA) strategies to target avoidance by helping youth identify stuck points in their lives through functional assessment of numerous life domains, including family and peer interactions, school, extracurricular activities, and health and self-care.
• The PASCET Program for Youth Depressive Disorders
The Primary and Secondary Control Enhancement Therapy (PASCET; Weisz, Southam-Gerow, Gordis, & Connor-Smith, 2003; Weisz, Southam-Gerow et al., 2009; Weisz, Thurber, Sweeney, Proffitt, & LeGagnoux, 1997) is a brief (usually 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, and beneficial treatments for, 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).
• The Coping Cat Program for Youth Anxiety Disorders
The "Coping Cat" program (Kendall & Hedtke, 2006; Kendall, Choudhury, Hudson, & Webb, 2002) has received substantial empirical support for its efficacy in both children (9-13 years old) and teens (12 - 17 years old) (Kendall, 1994; Kendall et al., 1997; Kendall et al., 2008) and 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.

Other:
• 14-week waitlist (WL) condition
Youth assigned to the 14-week WL will receive no specific therapeutic services from study therapists during the 14-week WL period. However, participants will be assigned a WL Liaison whom families can contact in the event of clinical deterioration. The Liaison will also be responsible for sending links to, and monitor completion of, weekly and mid-WL online surveys (Qualtrics). Independent Evaluators will conduct post-WL diagnostic interviews at the completion of the 14-week WL. WL participants will receive compensation for completion of assessments. After completion of the WL, participants will be invited to continue in the study and be randomly assigned to one of the three behavioral treatments (IBAT, PASCET, or Coping Cat).

Locations

Country	Name	City	State
United States	Youth Anxiety and Depression Clinic	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers University

Country where clinical trial is conducted

United States, 

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* Note: There are 103 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator	The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment. Subjects receiving a CGI-I rating of 1 (Very Much Improved) or 2 (Much Improved) by the IE at the end of posttreatment will be considered responders of treatment.	Change from pre-treatment to post-treatment (baseline to 14-weeks)
Secondary	Change in Behavioral Activation	The BADS-Y is a 26-item adaptation of the adult BADS (Kanter et al., 1997; Kanter et al., 1999), rated on a "0" (Not at All) to "6" (Completely) scale, designed to assess level of behavioral activation and avoidance. Factor analysis in the adult version detected four factors: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment) with good factor structure, internal consistency and test-retest reliability. Normative data was also collected in an adult community sample. BADS-A was adapted for the current study to reflect developmentally appropriate reading level and concepts.	Change from pre-treatment to post-treatment (baseline to 14-weeks)
Secondary	Child Automatic Thoughts Scale-Negative/Positive	The CATS is a 50-item child-report measure designed to assess negative and positive self-statements in children and adolescents. The CATS was developed and validated on a wide age range of youth (7 - 16 years old) and found to effectively discriminate between non-clinical youth and those with clinical anxiety, depression, and behavior disorders. Confirmatory factor analyses supported four distinct but strongly correlated factors relating to automatic thoughts on physical threat, social threat, personal failure and hostility. The internal consistency of the total score and subscales was high (a > .85) and test-retest reliability at 1 and 3 months was acceptable (r = .91).	Change from pre-treatment to post-treatment (baseline to 14-weeks)