Augmenting Exposure Therapy With Self-Distancing

NCT ID: NCT03549455

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2020-04-09

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.

Conditions

Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure Therapy and Self Distancing

Intervention Type: BEHAVIORAL

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;

Interventions

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;

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Emily Bilek

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Bilek, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00141761

Identifier Type: -

Identifier Source: org_study_id