Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC)
Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Rhode Island
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Pawtucket, Rhode Island, Forenede Stater, 02860
- Family Care Center at Memorial Hospital of Rhode Island
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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Computerized treatment targeting mental habits and primary care linkage.
Andre navne:
Weekly self-assessment with validated questionnaires and primary care linkage
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Aktiv komparator: 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.
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Weekly self-assessment with validated questionnaires and primary care linkage
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hamilton Anxiety Rating Scale
Tidsramme: 6-8 weeks after first treatment session
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Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.
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6-8 weeks after first treatment session
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Patientsundhedsspørgeskema-9
Tidsramme: 6-8 uger efter første behandlingssession
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6-8 uger efter første behandlingssession
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7-item Generalized Anxiety Disorder Scale
Tidsramme: 6-8 weeks after first treatment session
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6-8 weeks after first treatment session
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Courtney Beard, PhD, Harvard Medical School/McLean Hospital
- Ledende efterforsker: Risa B Weisberg, PhD, Brown University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1308000908-Phase 2
- 1R34MH097820-01A1 (U.S. NIH-bevilling/kontrakt)
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