Anxiety Disorders
Conditions
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 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.
Interventions
BEHAVIORALFaceAnxiety
Computerized treatment targeting mental habits and primary care linkage.
BEHAVIORALSymptom Tracking
Weekly self-assessment with validated questionnaires and primary care linkage
Sponsors
Mclean Hospital
Memorial Hospital of Rhode Island
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Scale | 6-8 weeks after first treatment session | Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score. |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | FaceAnxiety - Mental Habits | FaceAnxiety - Symptom Tracking | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 14.16 | 41.1 years STANDARD_DEVIATION 15.88 | 42.1 years STANDARD_DEVIATION 14.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment United States | 19 participants | 21 participants | 40 participants |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 1 / 21 |
Outcome results
Primary
Hamilton Anxiety Rating Scale
Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.
Time frame: 6-8 weeks after first treatment session
Population: We only analyzed participants who completed their post-treatment assessment, which is required to calculate their % reduction in symptoms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FaceAnxiety - Mental Habits | Hamilton Anxiety Rating Scale | 5 Participants |
| FaceAnxiety - Symptom Tracking | Hamilton Anxiety Rating Scale | 6 Participants |
Secondary
7-item Generalized Anxiety Disorder Scale
Time frame: 6-8 weeks after first treatment session
Secondary
Patient Health Questionnaire-9
Time frame: 6-8 weeks after first treatment session