Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Augmenting Exposure Therapy With Self-Distancing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549455
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Emily Bilek, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Exposure Therapy and Self Distancing Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmenting Exposure Therapy With Self-Distancing
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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;




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Treatment adherence and engagement [ Time Frame: Weeks 3, 4, 5, 6, 7, 8 ]
    The Treatment Engagement and Adherence Rating Scale (TEARS) will be used to assess subject completion of assigned homework, and engagement in in session practice by the child completing and therapist rating of exposure difficulty (0-10) and patient engagement (0-10).

  2. Change in anxiety severity [ Time Frame: Screening, Week 8 ]
    The Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) is a 41-item parent and participant-completed tool used to measure symptoms of anxiety, including the most common symptoms of panic/somatic, generalized anxiety, separation anxiety, social phobia, and school phobia. Scores range from 0-82, with higher scores indicating more severe symptoms. Both individual level changes and group mean differences will be examined.

  3. Change in Clinical Global Impressions - Severity and improvement scale (CGI) [ Time Frame: Screening, Weeks 1, 2, 3, 4, 5, 6, 7, 8 ]
    This is a 2 question clinician-rated scale where the scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases".

  4. Change in Clinical Global Impressions - Severity and improvement scale (CGI) [ Time Frame: Weeks, 1, 2, 3, 4, 5, 6, 7, 8 ]
    Only the improvement item will be completed by the parent with a score of 1 to 7 with 1 being "very much improved" and 7 being "very much worse".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549455


Locations
Layout table for location information
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Emily Bilek, PhD University of Michigan

Layout table for additonal information
Responsible Party: Emily Bilek, Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03549455     History of Changes
Other Study ID Numbers: HUM00141761
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emily Bilek, University of Michigan:
anxious
anxiety