Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02266446
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2014-07-15
Brief Title:
Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Phase 1 Open Trial of Attention and Interpretation Modification AIM for Anxiety Disorders in Primary Care
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIM-PC
Brief Summary:
The purpose of the study is to develop a personalized user-friendly computerized treatment for anxiety disorders linked to primary care The computerized treatment is a type of Cognitive Bias Modification which targets attention and interpretation biases known to maintain anxiety disorders
Detailed Description:
The primary goals of our 3-year 2-phase project are to develop AIM for primary care linkage and assess its feasibility and acceptability This protocol description only pertains to Part A treatment development and B open trial
As it is essential that AIM is eventually implementable in practice settings we integrate implementation methods in our early development work We will develop AIM to meet an existing need low-intensity anxiety disorder treatment ensure that it fits our local setting and identify eventual implementation barriers and facilitators via an open pilot trial We will strive to develop and pilot AIM in a manner that is perceived as compatible with existing practices simple to use advantageous relative to existing practice and beneficial In order to conduct ongoing evaluation a team of end users including Primary Care Physicians PCPs nurses patients and practice leaders at the Family Care Center FCC of Memorial Hospital of Rhode Island our study site and at other sites in Rhode Island and Massachusetts will participate on an Advisory Panel AP
Part A develop AIM including a 1 personalization computer program that will create an idiographic stimulus set for each participant to be used in the treatment 2 self-administered personalized Cognitive Bias Modification treatment and 3 protocol for primary care linked delivery
Part B an open trial of AIM comprising 3 iterations of 6 patients each After each iteration our study team and the AP will review data on feasibility and acceptability of AIM and delivery methods and make revisions as needed 8 primary care patients with primary Generalized Anxiety Disorder Social Anxiety Disorder andor Panic Disorder with or without Agoraphobia will be enrolled in 3 iterations Full assessments will occur pre- and post-treatment Weekly measures of anxiety and depression will be collected as will feedback from patients and PCPs about the research and delivery procedures At the end of the 1st iteration n6 the research team and AP will discuss and compare our actual data to the target outcomes Target outcomes were chosen on face validity clinical experience and when available relevant literature eg efficacy target based on previous trials and what we deemed clinically meaningful change for low-intensity treatment Deviations from target outcomes will prompt investigation and discussion and possible revision of AIM or of research procedures After revision we will recruit 6 new patients for the 2nd iteration At the end of this iteration the team and AP will review data and make changes as needed We will repeat this process in the 3rd iteration n6
Part C will include a randomized controlled trial of the final protocol
As it is essential that AIM is eventually implementable in practice settings we integrate implementation methods in our early development work We will develop AIM to meet an existing need low-intensity anxiety disorder treatment ensure that it fits our local setting and identify eventual implementation barriers and facilitators via an open pilot trial We will strive to develop and pilot AIM in a manner that is perceived as compatible with existing practices simple to use advantageous relative to existing practice and beneficial In order to conduct ongoing evaluation a team of end users including Primary Care Physicians PCPs nurses patients and practice leaders at the Family Care Center FCC of Memorial Hospital of Rhode Island our study site and at other sites in Rhode Island and Massachusetts will participate on an Advisory Panel AP
Part A develop AIM including a 1 personalization computer program that will create an idiographic stimulus set for each participant to be used in the treatment 2 self-administered personalized Cognitive Bias Modification treatment and 3 protocol for primary care linked delivery
Part B an open trial of AIM comprising 3 iterations of 6 patients each After each iteration our study team and the AP will review data on feasibility and acceptability of AIM and delivery methods and make revisions as needed 8 primary care patients with primary Generalized Anxiety Disorder Social Anxiety Disorder andor Panic Disorder with or without Agoraphobia will be enrolled in 3 iterations Full assessments will occur pre- and post-treatment Weekly measures of anxiety and depression will be collected as will feedback from patients and PCPs about the research and delivery procedures At the end of the 1st iteration n6 the research team and AP will discuss and compare our actual data to the target outcomes Target outcomes were chosen on face validity clinical experience and when available relevant literature eg efficacy target based on previous trials and what we deemed clinically meaningful change for low-intensity treatment Deviations from target outcomes will prompt investigation and discussion and possible revision of AIM or of research procedures After revision we will recruit 6 new patients for the 2nd iteration At the end of this iteration the team and AP will review data and make changes as needed We will repeat this process in the 3rd iteration n6
Part C will include a randomized controlled trial of the final protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R34MH097820-01A1 | NIH | None | httpsreporternihgovquickSearch1R34MH097820-01A1 |