Augmenting Exposure Therapy With Self-Distancing

Anxiety is prevalent, impairing, and costly in childhood. Evidence-based treatments for pediatric anxiety exist; however, as many as 40-60% of youth do not demonstrate optimal response. By identifying psychological factors that potentiate symptom severity and treatment response, it may be possible to strengthen these factors to treat, or even prevent the development of youth emotional disorders.

This study aims to examine whether the combination of Exposure and Self-Distancing is a feasible, acceptable, and efficient intervention for increasing perseverance in the face of exposures. This will be measured by child and parent report of treatment acceptability, examination of attendance and dropout rates, as well as participant and therapist report of participant engagement during exposures.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Exposure Therapy and Self Distancing

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent or guardian willing to give informed consent to participate
• Children who give written or oral assent
• Ages 7 and older to under 18 years old
• Has a historical anxiety diagnosis (diagnosed within the last year either within a clinical or clinical research setting) and have moderate or greater levels of current anxiety symptoms
• Current or past history of elevated symptoms of depression, obsessive-compulsive disorder and posttraumatic stress are allowable, but anxiety must be the chief complaint
• No evidence of acute risk due to suicidal intentions or behaviors in the past 6 months.

Exclusion Criteria:

• Currently receiving cognitive behavioral therapy or any other form of psychotherapy
• Have elevated symptoms of bipolar I/II disorder, schizophrenia/schizoaffective disorder, schizophreniform disorder, psychosis Not otherwise specified (NOS), mental retardation, severe behavioral concerns, or autism
• History of current substance/alcohol abuse/dependence (Past history abuse is allowable if in remission for greater than 1 year)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure Therapy and Self Distancing; All subjects will have 2 introduction sessions and then receive Exposure therapy with Self-Distancing (2 weeks) following Exposure therapy without Self-Distancing (2 weeks) followed by 2 more weeks of Exposure therapy with Self-Distancing.	Behavioral: Exposure Therapy and Self Distancing; Weeks 1 and 2 will be introductory sessions (background, rationale, motivational enhancement); Weeks 3 & 4 will have Exposure therapy with Self-Distancing; Weeks 5 & 6 will have Exposure therapy only; Weeks 7 & 8 will have Exposure therapy with Self-Distancing;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Self Distancing with exposure therapy	Treatment Acceptability Questionnaire version for the child and parent. Five Item scale (a score of 1 indicates that the care was not at all acceptable and a score of 7 would indicate a high level of acceptability). The treatment will be determined to have adequate acceptability and self-reported feasibility if parent and child report mean values greater than or equal to 5.	Week 8
Feasibility of Self Distancing based on treatment completion rates	Total number of sessions attended. Treatment will be determined to have adequate feasibility if participants attend, on average, greater than or equal to 70% of sessions, and high feasibility if participants attend, on average greater than or equal to 80% of sessions.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment adherence and engagement	The Treatment Engagement and Adherence Rating Scale (TEARS) will be used to assess subject completion of assigned homework, and engagement in in session practice by the child completing and therapist rating of exposure difficulty (0-10) and patient engagement (0-10).	Weeks 3, 4, 5, 6, 7, 8
Change in anxiety severity	The Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) is a 41-item parent and participant-completed tool used to measure symptoms of anxiety, including the most common symptoms of panic/somatic, generalized anxiety, separation anxiety, social phobia, and school phobia. Scores range from 0-82, with higher scores indicating more severe symptoms. Both individual level changes and group mean differences will be examined.	Screening, Week 8
Change in Clinical Global Impressions - Severity and improvement scale (CGI)	This is a 2 question clinician-rated scale where the scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases".	Screening, Weeks 1, 2, 3, 4, 5, 6, 7, 8
Change in Clinical Global Impressions - Severity and improvement scale (CGI)	Only the improvement item will be completed by the parent with a score of 1 to 7 with 1 being "very much improved" and 7 being "very much worse".	Weeks, 1, 2, 3, 4, 5, 6, 7, 8

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Emily Bilek, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): April 9, 2020
• Study Completion (Actual): April 9, 2020

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: anxiety; anxious
• Other Study ID Numbers: HUM00141761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No