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Implementation of Evidence-based Treatments for On-campus Eating Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02079142
First Posted: March 5, 2014
Last Update Posted: November 6, 2017
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.
Collaborators:
Department of Health and Human Services
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Denise Wilfley, Washington University School of Medicine
  Purpose
The purpose of this study is to evaluate two training methods of IPT with mental health service providers in college counseling centers.

Condition Intervention
Eating Disorders (Excluding Anorexia Nervosa) Depression Behavioral: High Intensity Strategy: Train-the-trainer Behavioral: Low Intensity Strategy: Expert Consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Implementation of Evidence-based Treatments for On-campus Eating Disorders

Resource links provided by NLM:


Further study details as provided by Denise Wilfley, Washington University School of Medicine:

Primary Outcome Measures:
  • Treatment Fidelity [ Time Frame: up to 53 months ]
    Treatment fidelity comprises two dimensions: adherence to the procedures of IPT and level of competence in applying these procedures. These dimensions will be rated separately, and the scores will be combined to form the primary outcome.


Secondary Outcome Measures:
  • Student Symptom [ Time Frame: up to 53 months ]
    Eating Disorder and Depression psychopathology will be assessed using a separate count of binge eating and purging (including episodes of self-induced vomiting, episodes of laxative and diuretic use, and episodes of fasting defined as 24 hours without food) for eating disorders and the PHQ-9 for Depression. This measure correlates well with data obtained from structured interviews. This measure will allow us to test the relationship between fidelity to IPT and client outcome.


Enrollment: 223
Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Strategy: Train-the-trainer
One therapist from each counseling center randomized to this arm will be selected to become the trainer and will be trained to train their colleagues.
Behavioral: High Intensity Strategy: Train-the-trainer

Trainers in the high intensity condition will attend two separate workshops at Washington University in St. Louis designed to teach participants to conduct IPT and then to train IPT. Following participation in the first, two-day workshop, each trainer will return to their site and be encouraged to treat at least two cases with eating disorders or depression, audio recording each session.

Trainers will then return to Washington University to be trained in how to train their other staff members in IPT.

Active Comparator: Low Intensity Strategy: Expert Consultation
The IPT expert from Washington University will travel to all counseling centers randomized to this condition and train all participating therapists on site and be available for monthly phone consultation for up to one year following training on site.
Behavioral: Low Intensity Strategy: Expert Consultation
Investigators will provide a two-day workshop on IPT at each site randomized to this condition to train therapists to use IPT for the treatment of Eating Disorders and depression.

Detailed Description:

Although there have been major advances in developing evidence-based psychotherapies, the adoption of such treatments by community therapists has been slow. One of the problems is the difficulty therapists in practice have in learning how to conduct an evidence-based psychotherapy. Hence, this study will investigate two methods of teaching therapists interpersonal therapy (IPT), an evidence based treatment for eating disorders and depression, at 40 college or University counseling centers.

Current approaches to training therapists to conduct new treatments typically consist of a one or two day workshop delivered by an expert and provision of a manual for the therapy in question. Recent reviews have concluded that while workshops increase therapists' knowledge, their impact on skills may be short-lived without further consultation. Thus, investigators will supplement IPT training manuals and workshops by offering monthly consultation calls to participating therapists for 12 months following the workshop. The consultation calls are not designed to be case supervision per se. Rather, they are to be seen as extended training on IPT. This training condition is referred to as expert consultation.

The second training strategy, referred to as train-the-trainer, features expertise capacity building within each organization. There is a strong theoretical case for this implementation strategy as it is based on the principles of social cognitive theory, featuring active learning via modeling, feedback on performance, building self-efficacy, and supportive interactions among therapists developing IPT skills. This 'train-the-trainer' approach involves active learning which centers around development of an internal coach and champion, and has been recommended as the most effective means of changing actual therapist behaviors rather than just attitudes and self-reported proficiency. Roth et al. have made the case that effective implementation of evidence-based treatment in routine clinical services requires that the training approximate that which characterized the research context (e.g., continuing feedback and supervision and monitoring of treatment fidelity). Our train-the-trainer strategy offers a practical means of accomplishing this goal.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently employed in a participating university counseling center
  • Providing regular student-client services
  Contacts and Locations
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): NCT02079142


Locations
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Department of Health and Human Services
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Denise E Wilfley, Ph.D. Washington University School of Medicine
Principal Investigator: Stewart Agras, MD Stanford University
Principal Investigator: Terrance G Wilson, Ph.D. Rutgers University
  More Information

Additional Information:
Responsible Party: Denise Wilfley, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02079142     History of Changes
Other Study ID Numbers: 1R01MH095748-01 ( U.S. NIH Grant/Contract )
1R01MH095748 ( U.S. NIH Grant/Contract )
First Submitted: March 3, 2014
First Posted: March 5, 2014
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms