Augmenting Exposure Therapy With Self-Distancing
|ClinicalTrials.gov Identifier: NCT03549455|
Recruitment Status : Active, not recruiting
First Posted : June 8, 2018
Last Update Posted : May 22, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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;
- 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.
- 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).
- 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.
- 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".
- 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".
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549455
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Emily Bilek, PhD||University of Michigan|