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OpenTrials
Completed

NCT Number: NCT03549455

Augmenting Exposure Therapy With Self-Distancing

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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;

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2018
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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