Anxiety DisordersAIM-PCNCT02266446
Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders
A study testing Attention & Interpretation Modification in people with Anxiety Disorders, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Attention & Interpretation Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2015
- 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
- Study site patient
- Age ≥18
- Primary diagnosis of Generalized anxiety disorder (GAD), Social Phobia (SP), and/or panic disorder with or without agoraphobia (PD/A)
- At least moderate anxiety severity (GAD-7 score > 10)
- English-speaking
- If on psychopharmacotherapy, stable dose for 3 months; to minimize learning effects, patients taking benzodiazepines will complete AIM prior to their first dose of the day
- No current psychotherapy
- No current severe psychiatric symptoms requiring immediate attention (e.g., imminent suicidality, psychosis)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Care Center of Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
Official title: Phase 1 Open Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
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.
Read the 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, and/or 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 (n=6), 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 (e.g., 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 (n=6).
Part C will include a randomized controlled trial of the final protocol.
- Conditions
- Anxiety Disorders
- Being tested
- Attention & Interpretation Modification
- Keywords
- anxiety disorders, cognitive bias modification, primary care, attention, interpretation, computer
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention & Interpretation ModificationBehavioural
Also called AIM, Cognitive Bias Modification
| Study group | Role | What they receive |
|---|---|---|
| Attention & Interpretation Modification | Experimental | The final product will be web-delivered, so it may be completed at the clinic or home. Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session Receives: Behavioral: Attention & Interpretation Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
Measured: 6-8 weeks after first treatment session
Secondary outcomes (2)
Generalized Anxiety Disorder 7-Item Scale
Measured: 6-8 weeks after first treatment session
Patient Health Questionnaire-9
Measured: 6-8 weeks after first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Model description
- Open trial
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Memorial Hospital of Rhode Island, Mclean Hospital
- Responsible party
- Principal investigator, Risa B Weisberg, Brown University
- Investigators
- Risa B Weisberg, PhD, Principal investigator, Alpert Medical School of Brown UniversityCourtney Beard, PhD, Principal investigator, Harvard Medical School/McLean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266446
- Sponsor's protocol ID
- 1308000908
- Other IDs
- 1R34MH097820-01A1
- Acronym
- AIM-PC
- Status last verified
- Jan 2018
- First submitted
- 15 Jul 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
- ClinicalTrials.gov ID
- NCT02266446
- Acronym / sponsor ID
- AIM-PC / 1308000908
- Conditions
- Anxiety Disorders
- Keywords
- anxiety disorders, cognitive bias modification, primary care, attention, interpretation, computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Memorial Hospital of Rhode Island, Mclean Hospital
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Oct 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 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, and/or 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 (n=6), 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 (e.g., 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 (n=6).
Part C will include a randomized controlled trial of the final protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open trial
| Arm | Type | Receives |
|---|---|---|
| Attention & Interpretation Modification | Experimental | Behavioral: Attention & Interpretation ModificationThe final product will be web-delivered, so it may be completed at the clinic or home. Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Study site patient
- Age ≥18
- Primary diagnosis of Generalized anxiety disorder (GAD), Social Phobia (SP), and/or panic disorder with or without agoraphobia (PD/A)
- At least moderate anxiety severity (GAD-7 score > 10)
- English-speaking
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 |
|---|---|---|
| Attention & Interpretation ModificationAlso: AIM, Cognitive Bias Modification | Behavioural | Attention & Interpretation Modification |
Primary outcome
Client Satisfaction Questionnaire
Time frame: 6-8 weeks after first treatment session
2 secondary outcomes
Generalized Anxiety Disorder 7-Item Scale
Time frame: 6-8 weeks after first treatment session
Patient Health Questionnaire-9
Time frame: 6-8 weeks after first treatment session
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 23 Jan 2018.
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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.
Risa B Weisberg, PhD principal investigator
Alpert Medical School of Brown University
Courtney Beard, PhD principal investigator
Harvard Medical School/McLean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention & Interpretation Modification in people with Anxiety Disorders, run by Brown University 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 8 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 23 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?
Client Satisfaction Questionnaire (time frame: 6-8 weeks after first treatment session). 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 23 Jan 2018.