GATE: Generalized Anxiety - A Treatment Evaluation
19 juni 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
226
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Förenta staterna, 02215
- Boston University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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
Andra namn:
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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)
Andra namn:
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Sham Comparator: 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)
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Proportion of Participants With Treatment Response
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
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Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Naomi M Simon, MD, MSc, NYU Langone Health
- Huvudutredare: Stefan G Hofmann, PhD, Boston University
- Huvudutredare: Eric Bui, MD, PhD, Massachusetts General Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2013
Primärt slutförande (Faktisk)
29 april 2019
Avslutad studie (Faktisk)
25 oktober 2019
Studieregistreringsdatum
Först inskickad
29 juli 2013
Först inskickad som uppfyllde QC-kriterierna
29 juli 2013
Första postat (Uppskatta)
31 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 juni 2020
Senast verifierad
1 juni 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- s17-00526
- 1R01AT007258-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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Kliniska prövningar på Generaliserat ångestsyndrom
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