GATE: Generalized Anxiety - A Treatment Evaluation
19. juni 2020 oppdatert av: NYU Langone Health
The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
We are currently conducting a treatment study to reduce stress and anxiety in people with generalized anxiety disorder (GAD).
This study will not use a medication, but instead will involve weekly stress reduction classes that use different strategies to reduce anxiety.
The study involves having a formal psychiatric interview, filling out questionnaires, ECGs, saliva samples, a urine test for drugs of abuse, and study visits over 12 weeks.
Each study visit will take a few hours.
Qualified participants will be compensated for time and travel.
Studietype
Intervensjonell
Registrering (Faktiske)
226
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02215
- Boston University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder
- Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher
- Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
- Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
- For women of childbearing potential, willingness to use a reliable form of birth control
Exclusion Criteria:
- Patients unable to understand study procedures and participate in the informed consent process.
- Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
- Women who are planning to become pregnant
- Serious medical illness or instability for which hospitalization may be likely within the next year
- Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
- History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
- Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
- Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
- Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
- Prior experience with (more than 5 Yoga classes or CBT sessions within the last 3 years) and/or current practice of mindbody techniques (e.g., yoga, meditation, Tai-Chi, etc) or cognitive behavioral therapy (CBT)
- Concomitant therapy for generalized anxiety disorder (GAD) (any therapy)
- Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
- Cognitive impairment (MOCA<21)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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: Yoga
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan.
This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices.
It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes.
The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors.
Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
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12 sessions, mindfulness components
Andre navn:
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Aktiv komparator: Cognitive Behavioral Therapy (CBT)
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available [88].
This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises.
The initial sessions describe the cognitive behavioral model of worry and GAD.
Each session consists of a different "lesson."
These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
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CBT focused on Generalized Anxiety Disorder (12 sessions)
Andre navn:
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Sham-komparator: Stress Education
SE will also include 12 weeks of group and home practice sessions.
SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention.
SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH.
In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
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Active control group (12 sessions)
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Proportion of Participants With Treatment Response
Tidsramme: Biweekly from weeks 0 through 12
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Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response.
This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure.
The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment.
The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement.
Our treatment response outcome variable was coded 0 if CGI-I was 3 or more.
Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
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Biweekly from weeks 0 through 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
Tidsramme: Weeks 0, 6 , 12 and 6 month follow up
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Weeks 0, 6 , 12 and 6 month follow up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Naomi M Simon, MD, MSc, NYU Langone Health
- Hovedetterforsker: Stefan G Hofmann, PhD, Boston University
- Hovedetterforsker: Eric Bui, MD, PhD, Massachusetts General Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Szuhany KL, Adhikari S, Chen A, Lubin RE, Jennings E, Rassaby M, Eakley R, Brown ML, Suzuki R, Barthel AL, Rosenfield D, Hoeppner SS, Khalsa SB, Bui E, Hofmann SG, Simon NM. Impact of preference for yoga or cognitive behavioral therapy in patients with generalized anxiety disorder on treatment outcomes and engagement. J Psychiatr Res. 2022 Sep;153:109-115. doi: 10.1016/j.jpsychires.2022.07.008. Epub 2022 Jul 5.
- Simon NM, Hofmann SG, Rosenfield D, Hoeppner SS, Hoge EA, Bui E, Khalsa SBS. Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jan 1;78(1):13-20. doi: 10.1001/jamapsychiatry.2020.2496.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2013
Primær fullføring (Faktiske)
29. april 2019
Studiet fullført (Faktiske)
25. oktober 2019
Datoer for studieregistrering
Først innsendt
29. juli 2013
Først innsendt som oppfylte QC-kriteriene
29. juli 2013
Først lagt ut (Anslag)
31. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- s17-00526
- 1R01AT007258-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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