Eating DisorderNCT03405077
Interpersonal Psychotherapy Online Training Study
A study testing IPT Online Training in people with Eating Disorder, run by Washington University School of Medicine.
Trial summary
Interpersonal psychotherapy (IPT) is an evidence-based therapy for the treatment of eating disorders (including binge eating disorder, bulimia nervosa, and disordered eating not meeting full diagnostic criteria). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorder
- What is being tested?
- IPT Online Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 26 Feb 2019
- 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
- Therapist must be a staff member at the counseling center and have a patient case-load large enough to be able to complete data collection at the different time points (>8 hours/week)
- Staff member is expected to continue working at the counseling center for several years • Postdocs who anticipate to be at their center for at least one year are eligible
- Student patients of therapists who seek counseling services at their respective schools
- Students exhibiting symptoms of an eating disorder
Who cannot join
- Therapists from all universities affiliated with the NIH-funded trial (IRB# 201111113)
- Therapists working less than 8 hours/week
- Therapists who are anticipating leaving employment at the recruited counseling center within the time frame of the study including, but not limited to trainees and interns
- Therapists for whom their administrative duties preclude seeing a sufficient number of clients to be able to complete data collection at the different study time points
- Therapists who do not see students seeking treatment for eating disorders
- Individuals who are non-degreed trainees (i.e., psychology interns)
- STUDENTS:
- Students exhibiting symptoms of anorexia nervosa
About this study
Official title: Harnessing Technology for Training Clinicians to Deliver Interpersonal Psychotherapy
Interpersonal psychotherapy (IPT) is an evidence-based therapy for the treatment of eating disorders (including binge eating disorder, bulimia nervosa, and disordered eating not meeting full diagnostic criteria). On a basic level, IPT is a time-limited treatment that helps the client understand the relationship between symptoms and social interactions. Traditional training methods require substantial cost, time, and resources, making evidence-based treatments difficult to disseminate. As such, college clinicians are not typically trained in IPT delivery, which prevents their clients from reaping the potential benefits of treatment. This study will attempt to show how technology can overcome such barriers to training dissemination.
The purpose of this study is to see if online training in IPT is as effective as in-person training. To find out, the following procedures will occur: First, college mental health clinicians will complete baseline online questionnaires and deliver their usual treatment to 1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online training program and post-training assessments. Next, they will treat 1 or 2 different clients with eating disorders and complete post-training assessments. As part of the baseline and post-training assessments, clinicians will complete a telephone-based simulation assessment with staff raters, in which the investigators will recreate a client session and rate how well the clinicians adhere to IPT in treating the simulated client. The guided on-line training program will ultimately be compared to the "gold standard" training (the group receiving in-person training in an associated, IRB-approved study, # 201111113).
- Conditions
- Eating Disorder
- Being tested
- IPT Online Training
- Keywords
- interpersonal psychotherapy, treatment, training, dissemination and implementation, eating disorders
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT Online TrainingBehavioural
First, college mental health clinicians will complete baseline online questionnaires and deliver their usual treatment to 1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online training program and post-training assessments. Next, they will treat 1 or 2 different clients with eating disorders and complete post-training assessments. As part of the baseline and post-training assessments, clinicians will complete a telephone-based simulation assessment with staff raters, in which the investigators will recreate a client session and rate how well the clinicians adhere to IPT in treating the simulated client. The guided on-line training program will ultimately be compared to the "gold standard" training.
| Study group | Role | What they receive |
|---|---|---|
| IPT Online Training | Experimental | Therapists in this study will be trained in IPT using an online platform. The program is self-paced but will have a deadline; the suggested pace is at least 12 hours spaced over 2 months. The guided online training program was developed in collaboration with 3C institute, an award-winning research and development company that creates web- and evidence-based programs. Content will be adapted from "gold-standard" training. Receives: Behavioral: IPT Online Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment fidelity: Adherence
Therapist's adherence to the procedures of IPT. This will be assessed using the IPT Fidelity Assessment. This scale was developed for the current study and was informed by work done by the Veterans' Health Administration, previous work conducted by the Principal Investigators of the current trial, and by other IPT researchers training therapists to conduct evidence-based treatments.
Measured: 1-3 years
Secondary outcomes (1)
Treatment fidelity: Competence
Therapist's level of competence in applying the procedures of IPT. This will be assessed using the IPT Fidelity Assessment. This scale was developed for the current study and was informed by work done by the Veterans' Health Administration, previous work conducted by the Principal Investigators of the current trial, and by other IPT researchers training therapists to conduct evidence-based treatments.
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study startJan 2016
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Wilfley, PhD, Principal investigator, Scott Rudolph University Professor of Psychiatry, Medicine, Pediatrics, and Psychological & Brain Sciences, Washington University School of MedicineTerry Wilson, PhD, Study director, Oscar K. Buros Professor of Psychology, Rutgers UniversityStewart Agras, MD, Study director, Professor of Psychiatry (Emeritus), Stanford University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405077
- Sponsor's protocol ID
- 201408037
- Status last verified
- Mar 2019
- First submitted
- 12 Dec 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Technology for Training Clinicians to Deliver Interpersonal Psychotherapy
- ClinicalTrials.gov ID
- NCT03405077
- Acronym / sponsor ID
- 201408037
- Conditions
- Eating Disorder
- Keywords
- interpersonal psychotherapy, treatment, training, dissemination and implementation, eating disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- 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.
Interpersonal psychotherapy (IPT) is an evidence-based therapy for the treatment of eating disorders (including binge eating disorder, bulimia nervosa, and disordered eating not meeting full diagnostic criteria). On a basic level, IPT is a time-limited treatment that helps the client understand the relationship between symptoms and social interactions. Traditional training methods require substantial cost, time, and resources, making evidence-based treatments difficult to disseminate. As such, college clinicians are not typically trained in IPT delivery, which prevents their clients from reaping the potential benefits of treatment. This study will attempt to show how technology can overcome such barriers to training dissemination.
The purpose of this study is to see if online training in IPT is as effective as in-person training. To find out, the following procedures will occur: First, college mental health clinicians will complete baseline online questionnaires and deliver their usual treatment to 1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online training program and post-training assessments. Next, they will treat 1 or 2 different clients with eating disorders and complete post-training assessments. As part of the baseline and post-training assessments, clinicians will complete a telephone-based simulation assessment with staff raters, in which the investigators will recreate a client session and rate how well the clinicians adhere to IPT in treating the simulated client. The guided on-line training program will ultimately be compared to the "gold standard" training (the group receiving in-person training in an associated, IRB-approved study, # 201111113).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPT Online Training | Experimental | Behavioral: IPT Online TrainingTherapists in this study will be trained in IPT using an online platform. The program is self-paced but will have a deadline; the suggested pace is at least 12 hours spaced over 2 months. The guided online training program was developed in collaboration with 3C institute, an award-winning research and development company that creates web- and evidence-based programs. Content will be adapted from "gold-standard" training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Therapist must be a staff member at the counseling center and have a patient case-load large enough to be able to complete data collection at the different time points (>8 hours/week)
- Staff member is expected to continue working at the counseling center for several years • Postdocs who anticipate to be at their center for at least one year are eligible
- Student patients of therapists who seek counseling services at their respective schools
- Students exhibiting symptoms of an eating disorder
Key exclusion criteria (8 listed)
- Therapists from all universities affiliated with the NIH-funded trial (IRB# 201111113)
- Therapists working less than 8 hours/week
- Therapists who are anticipating leaving employment at the recruited counseling center within the time frame of the study including, but not limited to trainees and interns
- Therapists for whom their administrative duties preclude seeing a sufficient number of clients to be able to complete data collection at the different study time points
- Therapists who do not see students seeking treatment for eating disorders
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 |
|---|---|---|
| IPT Online TrainingFirst, college mental health clinicians will complete baseline online questionnaires and deliver their usual treatment to 1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online training program and post-training assessments. Next, they will treat 1 or 2 different clients with eating disorders and complete post-training assessments. As part of the baseline and post-training assessments, clinicians will complete a telephone-based simulation assessment with staff raters, in which the investigators will recreate a client session and rate how well the clinicians adhere to IPT in treating the simulated client. The guided on-line training program will ultimately be compared to the "gold standard" training. | Behavioural | IPT Online Training |
Primary outcome
Treatment fidelity: Adherence
Time frame: 1-3 years
Therapist's adherence to the procedures of IPT. This will be assessed using the IPT Fidelity Assessment. This scale was developed for the current study and was informed by work done by the Veterans' Health Administration, previous work conducted by the Principal Investigators of the current trial, and by other IPT researchers training therapists to conduct evidence-based treatments.
1 secondary outcome
Treatment fidelity: Competence
Time frame: 1-3 years
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 28 Mar 2019.
- Individual participant dataSharing planned: No
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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 Wilfley, PhD principal investigator
Scott Rudolph University Professor of Psychiatry, Medicine, Pediatrics, and Psychological & Brain Sciences, Washington University School of Medicine
Terry Wilson, PhD study director
Oscar K. Buros Professor of Psychology, Rutgers University
Stewart Agras, MD study director
Professor of Psychiatry (Emeritus), Stanford University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing IPT Online Training in people with Eating Disorder, run by Washington University School of Medicine.
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 4 inclusion and 8 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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: Adherence (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.