Implementation of Evidence-based Treatments for On-campus Eating Disorders
Primary Purpose
Eating Disorders (Excluding Anorexia Nervosa), Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Strategy: Train-the-trainer
Low Intensity Strategy: Expert Consultation
Sponsored by
About this trial
This is an interventional other trial for Eating Disorders (Excluding Anorexia Nervosa)
Eligibility Criteria
Inclusion Criteria:
- Currently employed in a participating university counseling center
- Providing regular student-client services
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Intensity Strategy: Train-the-trainer
Low Intensity Strategy: Expert Consultation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Treatment Fidelity
Treatment fidelity comprises two dimensions: adherence to the procedures of IPT and level of competence in applying these procedures.
Secondary Outcome Measures
Student Symptom
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.
Full Information
NCT ID
NCT02079142
First Posted
March 3, 2014
Last Updated
January 8, 2018
Sponsor
Washington University School of Medicine
Collaborators
Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02079142
Brief Title
Implementation of Evidence-based Treatments for On-campus Eating Disorders
Official Title
Implementation of Evidence-based Treatments for On-campus Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate two training methods of IPT with mental health service providers in college counseling centers.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders (Excluding Anorexia Nervosa), Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Strategy: Train-the-trainer
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Intensity Strategy: Expert Consultation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Strategy: Train-the-trainer
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Intensity Strategy: Expert Consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Fidelity
Description
Treatment fidelity comprises two dimensions: adherence to the procedures of IPT and level of competence in applying these procedures.
Time Frame
up to 53 months
Secondary Outcome Measure Information:
Title
Student Symptom
Description
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.
Time Frame
up to 53 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently employed in a participating university counseling center
Providing regular student-client services
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise E Wilfley, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stewart Agras, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terrance G Wilson, Ph.D.
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31693069
Citation
Wilfley DE, Agras WS, Fitzsimmons-Craft EE, Bohon C, Eichen DM, Welch RR, Jo B, Raghavan R, Proctor EK, Wilson GT. Training Models for Implementing Evidence-Based Psychological Treatment: A Cluster-Randomized Trial in College Counseling Centers. JAMA Psychiatry. 2020 Feb 1;77(2):139-147. doi: 10.1001/jamapsychiatry.2019.3483. Erratum In: JAMA Psychiatry. 2019 Nov 27;:
Results Reference
derived
Learn more about this trial
Implementation of Evidence-based Treatments for On-campus Eating Disorders
We'll reach out to this number within 24 hrs