Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH097820-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Mclean Hospital | OTHER |
| Memorial Hospital of Rhode Island | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 Phase 2 (Randomized Controlled Trial).
42 primary care patients with primary Generalized Anxiety Disorder, Social Anxiety Disorder, and/or Panic Disorder (with or without Agoraphobia) will be randomly assigned to the AIM treatment or to a symptom tracking control group. Full assessments will occur pre- and post-treatment and 3-months follow-up. A mid-treatment assessment will include measures of cognitive biases and the primary outcome. Weekly measures of anxiety and depression will be collected, as will feedback from patients and PCPs about the research and delivery procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FaceAnxiety - Mental Habits | Experimental | 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. A FaceAnxiety Specialist facilitates program completion. |
|
| FaceAnxiety - Symptom Tracking | Active Comparator | Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FaceAnxiety | Behavioral | Computerized treatment targeting mental habits and primary care linkage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Rating Scale | Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score. | 6-8 weeks after first treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| 7-item Generalized Anxiety Disorder Scale | 6-8 weeks after first treatment session | |
| Patient Health Questionnaire-9 | 6-8 weeks after first treatment session |
Not provided
Inclusion Criteria:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Risa B Weisberg, PhD | Brown University | Principal Investigator |
| Courtney Beard, PhD | Harvard Medical School/McLean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Care Center at Memorial Hospital of Rhode Island | Pawtucket | Rhode Island | 02860 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FaceAnxiety - Mental Habits | 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. A FaceAnxiety Specialist facilitates program completion. FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage |
| FG001 | FaceAnxiety - Symptom Tracking | Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Note that one participant in each arm did not provide age data. Thus, total number of baseline participants differs from those analyzed for age.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FaceAnxiety - Mental Habits | 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. A FaceAnxiety Specialist facilitates program completion. FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 participant from each arm did not provide their age. These data are missing. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Anxiety Rating Scale | Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score. | We only analyzed participants who completed their post-treatment assessment, which is required to calculate their % reduction in symptoms. | Posted | Count of Participants | Participants | 6-8 weeks after first treatment session |
|
Participants were followed for 3 months following their post-treatment assessment. Thus, in total participants were followed for up to 6 months depending on how quickly they completed the treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FaceAnxiety - Mental Habits | 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. A FaceAnxiety Specialist facilitates program completion. FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicide attempt | Psychiatric disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Beard | McLean Hospital | 16178553557 | CBEARD@MCLEAN.HARVARD.EDU |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2017 | Jan 13, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2017 | Jan 13, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Symptom Tracking | Behavioral | Weekly self-assessment with validated questionnaires and primary care linkage |
|
| BG001 | FaceAnxiety - Symptom Tracking | Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Note that one participant in each arm did not provide age data. Thus, total number of baseline participants differs from those analyzed for age. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | FaceAnxiety - Symptom Tracking | Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage |
|
|
| Secondary | 7-item Generalized Anxiety Disorder Scale | Not Posted | 6-8 weeks after first treatment session | Participants |
| Secondary | Patient Health Questionnaire-9 | Not Posted | 6-8 weeks after first treatment session | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | FaceAnxiety - Symptom Tracking | Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion. Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage | 0 | 21 | 1 | 21 | 0 | 21 |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|