Depressive SymptomsNCT03170908
Effective Implementation of Interpersonal Psychotherapy
An observational study of Depressive Symptoms, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 6 Dec 2019
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-99 seeking psychotherapy for depression in community-based agencies
Who may be able to join
- age 18-99
- diagnosis of depressive disorder
- being treated with IPT in community settings
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Strategies for Assessing and Enhancing High Fidelity Delivery of Interpersonal Psychotherapy (IPT) in Community Practice
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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- Interpersonal Psychotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
Interpersonal Psychotherapy (IPT) is an empirically-validated time-limited treatment for depression
| Study group | Role | What they receive |
|---|---|---|
| Phase I Patients | Patients with depression receiving community-based services will receive Interpersonal Psychotherapy Receives: Behavioral: Interpersonal Psychotherapy | |
| Phase II Patients | Patients with depression receiving community-based services will receive Interpersonal Psychotherapy Receives: Behavioral: Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9
Patient Health Questionnaire-9
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start19 May 2017
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Why it stopped: Conflict of Interest (COI) cannot be managed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170908
- Sponsor's protocol ID
- 201705766
- Other IDs
- 1R01MH112624
- Status last verified
- Jun 2022
- First submitted
- 26 May 2017
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we do not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Strategies for Assessing and Enhancing High Fidelity Delivery of Interpersonal Psychotherapy (IPT) in Community Practice
- ClinicalTrials.gov ID
- NCT03170908
- Acronym / sponsor ID
- 201705766
- Conditions
- Depressive Symptoms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Conflict of Interest (COI) cannot be managed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 31 May 2017 (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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I Patients | – | Behavioral: Interpersonal PsychotherapyPatients with depression receiving community-based services will receive Interpersonal Psychotherapy |
| Phase II Patients | – | Behavioral: Interpersonal PsychotherapyPatients with depression receiving community-based services will receive Interpersonal Psychotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-99 seeking psychotherapy for depression in community-based agencies
Key inclusion criteria (3 listed)
- age 18-99
- diagnosis of depressive disorder
- being treated with IPT in community settings
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Interpersonal PsychotherapyInterpersonal Psychotherapy (IPT) is an empirically-validated time-limited treatment for depression | Behavioural | Phase I Patients, Phase II Patients |
Primary outcome
PHQ-9
Time frame: one year
Patient Health Questionnaire-9
Results and safety
The study was stopped early (reason given: Conflict of Interest (COI) cannot be managed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No. we do not plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms, run by University of Iowa 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jun 2022. 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 was stopped early (reason given: Conflict of Interest (COI) cannot be managed). Results are not available in the source record.
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?
PHQ-9 (time frame: one year). 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 9 Jun 2022.