| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT007258-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga | Experimental | 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. |
|
| Cognitive Behavioral Therapy (CBT) | Active Comparator | 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. |
|
| Stress Education | Sham Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | CBT focused on Generalized Anxiety Disorder (12 sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Treatment Response | 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). | Biweekly from weeks 0 through 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) | Weeks 0, 6 , 12 and 6 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi M Simon, MD, MSc | NYU Langone Health | Principal Investigator |
| Stefan G Hofmann, PhD | Boston University | Principal Investigator |
| Eric Bui, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Boston University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41252645 | Derived | Keltz S, Quintana L, Szuhany KL, Adhikari S, Twi-Yeboah A, Baker AW, Khalsa SBS, Hoge E, Bui E, Hoeppner SS, Rosenfield D, Hofmann SG, Simon NM. Impact of homework engagement on treatment response to group cognitive-behavioral therapy, yoga, and stress education for generalized anxiety disorder. Cogn Behav Ther. 2025 Nov 18:1-12. doi: 10.1080/16506073.2025.2589392. Online ahead of print. | |
| 37598625 | Derived | Hoge EA, Simon NM, Szuhany K, Feldman B, Rosenfield D, Hoeppner S, Jennings E, Khalsa SB, Hofmann SG. Comparing Kundalini Yoga, cognitive behavioral therapy, and stress education for generalized anxiety disorder: Anxiety and depression symptom outcomes. Psychiatry Res. 2023 Sep;327:115362. doi: 10.1016/j.psychres.2023.115362. Epub 2023 Aug 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Yoga: 12 sessions, mindfulness components |
| FG001 | 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. 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. |
| FG002 | 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. Stress Education: Active control group (12 sessions) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Yoga: 12 sessions, mindfulness components |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Treatment Response | 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). | Posted | Number | Proportion of participants | Biweekly from weeks 0 through 12 |
|
37 weeks
Adverse events assessed 1x/week from baseline to 6 month follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Yoga: 12 sessions, mindfulness components |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amenorrhea | Reproductive system and breast disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Simon | NYU Langone Health | 646-754-4507 | Naomi.Simon@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 20, 2017 | Apr 30, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D015013 | Yoga |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
|
| Stress Education | Behavioral | Active control group (12 sessions) |
|
|
| Yoga | Behavioral | 12 sessions, mindfulness components |
|
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| 35810600 | Derived | 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. |
| 32805013 | Derived | 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. |
| Dissatisfaction with assigned treatment |
|
| Felt treatment no longer needed |
|
| Life circumstances |
|
| Lost Interest |
|
| Uknown reason - subject drop out |
|
| Missed Assesment |
|
| Scheduling/change in availability |
|
| BG001 | 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. 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. |
| BG002 | 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. Stress Education: Active control group (12 sessions) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. 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. |
| OG002 | 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. Stress Education: Active control group (12 sessions) |
|
|
|
| Secondary | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) | Not Posted | Weeks 0, 6 , 12 and 6 month follow up | Participants |
| 0 |
| 93 |
| 0 |
| 93 |
| 40 |
| 93 |
| EG001 | 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. 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. | 0 | 90 | 1 | 90 | 34 | 90 |
| EG002 | 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. Stress Education: Active control group (12 sessions) | 0 | 43 | 0 | 43 | 8 | 43 |
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Mental Distress | Psychiatric disorders | Systematic Assessment |
|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Tingling | General disorders | Systematic Assessment |
|
| Vertigo | Nervous system disorders | Systematic Assessment |
|
| Vision Abnormal | Eye disorders | Systematic Assessment |
|
| Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Assault | General disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bulimia | Psychiatric disorders | Systematic Assessment |
|
| Faint | General disorders | Systematic Assessment |
|
| Flu | General disorders | Systematic Assessment |
|
| Lymph Nodes Enlarged | Blood and lymphatic system disorders | Systematic Assessment |
|
| pain | General disorders | Systematic Assessment |
|
| Mood Change | Psychiatric disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |