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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Rhode Island
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Pawtucket, Rhode Island, Forente stater, 02860
- Family Care Center at Memorial Hospital of Rhode Island
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Pasienthelsespørreskjema-9
Tidsramme: 6-8 uker etter første behandlingsøkt
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6-8 uker etter første behandlingsøkt
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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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Courtney Beard, PhD, Harvard Medical School/McLean Hospital
- Hovedetterforsker: Risa B Weisberg, PhD, Brown University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1308000908-Phase 2
- 1R34MH097820-01A1 (U.S. NIH-stipend/kontrakt)
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