Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effective Implementation of Interpersonal Psychotherapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170908
Recruitment Status : Not yet recruiting
First Posted : May 31, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Scott P. Stuart, University of Iowa

Tracking Information
First Submitted Date May 26, 2017
First Posted Date May 31, 2017
Last Update Posted Date April 8, 2019
Estimated Study Start Date July 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2017)		 PHQ-9 [ Time Frame: one year ]
Patient Health Questionnaire-9
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effective Implementation of Interpersonal Psychotherapy
Official Title Pragmatic Strategies for Assessing and Enhancing High Fidelity Delivery of Interpersonal Psychotherapy (IPT) in Community Practice
Brief Summary The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. Pairs of therapist-patient dyads will be observed, first to develop and test brief measures of fidelity, and then to correlate those measures with symptomatic outcomes.
Detailed Description The study is designed to observe the impact of improved measures of the fidelity on the community delivery of Interpersonal Psychotherapy. In Phase I, 250 pairs of therapist-patient dyads will be observed as IPT Fidelity measures are developed and validated. In Phase II, 175 pairs of therapist-patient dyads will be observed to prospectively validate the IPT Fidelity measures with longitudinal outcomes on the PHQ-9.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged 18-99 seeking psychotherapy for depression in community-based agencies
Condition Depressive Symptoms
Intervention Behavioral: Interpersonal Psychotherapy
Interpersonal Psychotherapy (IPT) is an empirically-validated time-limited treatment for depression
Study Groups/Cohorts
  • Phase I Patients
    Patients with depression receiving community-based services will receive Interpersonal Psychotherapy
    Intervention: Behavioral: Interpersonal Psychotherapy
  • Phase II Patients
    Patients with depression receiving community-based services will receive Interpersonal Psychotherapy
    Intervention: Behavioral: Interpersonal Psychotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 26, 2017)		 425
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age 18-99
  • diagnosis of depressive disorder
  • being treated with IPT in community settings

Exclusion Criteria:

- none
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03170908
Other Study ID Numbers 201705766
1R01MH112624 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: we do not plan to share IPD
Responsible Party Scott P. Stuart, University of Iowa
Study Sponsor Scott P. Stuart
Collaborators National Institute of Mental Health (NIMH)
Investigators Not Provided
PRS Account University of Iowa
Verification Date April 2019