Clinical trial NCT03549455: Augmenting Exposure Therapy With Self-Distancing
Official title: Augmenting Exposure Therapy With Self-Distancing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxious
anxiety
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Acceptability of Self Distancing with exposure therapy
timeFrame: Week 8
measure: Feasibility of Self Distancing based on treatment completion rates
timeFrame: Week 8
Secondary outcomes:
measure: Treatment adherence and engagement
timeFrame: Weeks 3, 4, 5, 6, 7, 8
measure: Change in anxiety severity
timeFrame: Screening, Week 8
measure: Change in Clinical Global Impressions - Severity and improvement scale (CGI)
timeFrame: Screening, Weeks 1, 2, 3, 4, 5, 6, 7, 8
measure: Change in Clinical Global Impressions - Severity and improvement scale (CGI)
timeFrame: Weeks, 1, 2, 3, 4, 5, 6, 7, 8
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Emily Bilek, PhD
role: PRINCIPAL_INVESTIGATOR
References: