Eating Disorders (Excluding Anorexia Nervosa)NCT02079142
Implementation of Evidence-based Treatments for On-campus Eating Disorders
A study testing High Intensity Strategy: Train-the-trainer and Low Intensity Strategy: Expert Consultation in people with Eating Disorders (Excluding Anorexia Nervosa) and Depression, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate two training methods of IPT with mental health service providers in college counseling centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders (Excluding Anorexia Nervosa), Depression
- What is being tested?
- High Intensity Strategy: Train-the-trainer and Low Intensity Strategy: Expert Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently employed in a participating university counseling center
- Providing regular student-client services
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63108
About this study
The purpose of this study is to evaluate two training methods of IPT with mental health service providers in college counseling centers.
Read the 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.
- Being tested
- High Intensity Strategy: Train-the-trainer, Low Intensity Strategy: Expert Consultation
- Medical subject headings
- Feeding and Eating Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Strategy: Train-the-trainerBehavioural
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.
Low Intensity Strategy: Expert ConsultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Strategy: Train-the-trainer | Experimental | 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. Receives: Behavioral: High Intensity Strategy: Train-the-trainer |
| Low Intensity Strategy: Expert Consultation | Active comparator | 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. Receives: Behavioral: Low Intensity Strategy: Expert Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Fidelity
Treatment fidelity comprises two dimensions: adherence to the procedures of IPT and level of competence in applying these procedures.
Measured: up to 53 months
Secondary outcomes (1)
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.
Measured: up to 53 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating Disorders (Excluding Anorexia Nervosa)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Denise Wilfley, Washington University School of Medicine
- Investigators
- Denise E Wilfley, Ph.D., Principal investigator, Washington University School of MedicineStewart Agras, MD, Principal investigator, Stanford UniversityTerrance G Wilson, Ph.D., Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079142
- Sponsor's protocol ID
- 1R01MH095748-01
- Other IDs
- 1R01MH095748
- Status last verified
- Jan 2018
- First submitted
- 3 Mar 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raghavan R, Fitzsimmons-Craft EE, Welch RR, Jo B, Proctor EK, Wilson GT, Agras WS, Wilfley DE. Cost-effectiveness of train-the-trainer versus expert consultation training models for implementing interpersonal psychotherapy in college mental health settings: evidence from a national cluster randomized trial. Implement Sci. 2024 Jul 29;19(1):55. doi: 10.1186/s13012-024-01388-2.
PubMed 39075590Wilfley 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.
PubMed 31693069
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Evidence-based Treatments for On-campus Eating Disorders
- ClinicalTrials.gov ID
- NCT02079142
- Acronym / sponsor ID
- 1R01MH095748-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- Apr 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Strategy: Train-the-trainer | Experimental | Behavioral: High Intensity Strategy: Train-the-trainerOne therapist from each counseling center randomized to this arm will be selected to become the trainer and will be trained to train their colleagues. |
| Low Intensity Strategy: Expert Consultation | Active comparator | Behavioral: Low Intensity Strategy: Expert ConsultationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently employed in a participating university counseling center
- Providing regular student-client services
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Strategy: Train-the-trainerTrainers 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. | Behavioural | High Intensity Strategy: Train-the-trainer |
| Low Intensity Strategy: Expert ConsultationInvestigators 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. | Behavioural | Low Intensity Strategy: Expert Consultation |
Primary outcome
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.
1 secondary outcome
Student Symptom
Time frame: up to 53 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Derived from this study: PubMed 39075590Raghavan R, Fitzsimmons-Craft EE, Welch RR, Jo B, Proctor EK, Wilson GT, Agras WS, Wilfley DE. Cost-effectiveness of train-the-trainer versus expert consultation training models for implementing interpersonal psychotherapy in college mental health settings: evidence from a national cluster randomized trial. Implement Sci. 2024 Jul 29;19(1):55. doi: 10.1186/s13012-024-01388-2.
- Derived from this study: PubMed 31693069Wilfley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise E Wilfley, Ph.D. principal investigator
Washington University School of Medicine
Stewart Agras, MD principal investigator
Stanford University
Terrance G Wilson, Ph.D. principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Strategy: Train-the-trainer and Low Intensity Strategy: Expert Consultation in people with Eating Disorders (Excluding Anorexia Nervosa) and Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Fidelity (time frame: up to 53 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.