Augmenting Exposure Therapy With Self-Distancing

NCT03549455 | Completed

• 1 other identifier: HUM00141761
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

anxious; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

  Screening, Weeks 1, 2, 3, 4, 5, 6, 7, 8

• Change in Clinical Global Impressions - Severity and improvement scale (CGI)

  Weeks, 1, 2, 3, 4, 5, 6, 7, 8

Study Arms (1)

Exposure Therapy and Self Distancing

EXPERIMENTAL

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

Interventions

Exposure Therapy and Self Distancing 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;

Exposure Therapy and Self Distancing

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emily Bilek, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: August 30, 2018
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

US (1)