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Clinical Trials/NCT03549455
NCT03549455
Completed
N/A

Augmenting Exposure Therapy With Self-Distancing

University of Michigan1 site in 1 country10 target enrollmentAugust 30, 2018
ConditionsAnxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Michigan
Enrollment
10
Locations
1
Primary Endpoint
Acceptability of Self Distancing with exposure therapy
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2018
End Date
April 9, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Bilek

Clinical Assistant Professor

University of Michigan

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Acceptability of Self Distancing with exposure therapy

Time Frame: Week 8

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.

Feasibility of Self Distancing based on treatment completion rates

Time Frame: Week 8

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.

Secondary Outcomes

  • Treatment adherence and engagement(Weeks 3, 4, 5, 6, 7, 8)
  • Change in anxiety severity(Screening, Week 8)
  • Change in Clinical Global Impressions - Severity and improvement scale (CGI)(Weeks, 1, 2, 3, 4, 5, 6, 7, 8)

Study Sites (1)

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