Augmenting Exposure Therapy With Self-Distancing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Acceptability of Self Distancing with exposure therapy
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Exposure Therapy and Self Distancing (Behavioral)
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)
- Change in Clinical Global Impressions - Severity and improvement scale (CGI)(Screening, Weeks 1, 2, 3, 4, 5, 6, 7, 8)
Investigators
Emily Bilek
Clinical Assistant Professor
University of Michigan