- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03072264
Randomized Clinical Trial of a Mindfulness Based Intervention in Generalized Anxiety Disorder
Randomized Clinical Trial Comparing Mindfulness, Pharmacological Treatment, and Control Group in Generalized Anxiety Disorder (GAD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Generalized Anxiety Disorder (GAD) is the most prevalent Anxiety Disorder after Specific Phobia. It is characterized by persistent and excessive anxiety and worry about different domains of life that is difficult to control, and the individuals can experience physical symptoms, like restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance. Also, GAD is one of the most common mental disorders in primary care settings, and it is associated with increased use of health care resources and disability, functional impairment, psychiatric and medical comorbidities.
Despite its prevalence and impairment, this disorder is under-recognized, and less than one-third of patients are adequately treated. The literature demonstrates that either psychotropic medications or cognitive behavior therapy (CBT) appear to be effective for treating GAD. However, a substantial number of patients do not respond to initial treatment, and, although the response rates are inconsistent across studies, only 38% of the treated patients have a remission after five years. Moreover, GAD is usually a chronic disorder with a waxing and waning course, requiring a long-term treatment.
In relation to some biological mechanisms in GAD, some studies report an enhanced Error-Related Negativity (ERN) and a lower Heart Rate Variability (HRV) in GAD patients. The first biological marker could be associated with anxious apprehension and the main findings are found in GAD while the second one reflects a reduction in parasympathetic modulation. On the other hand, it is already known that mindfulness meditation practice is associated with increase in autonomic regulation by stimulating the parasympathetic system. In relation to cognitive factors, the literature demonstrates that GAD patients have a higher level of experiential avoidance and distress about emotions, more negative believes about worry and meta-worry.
Mindfulness is a practice developed to foster self-regulation. Historically, the mindfulness exercises used in clinical protocols are linked with the Buddhist framework in which it is a means to alleviate suffering and cultivate compassion. In the West, the role of mindfulness in health promotion has been the target of studies since the 70s and it has been incorporated in cognitive-behavioural treatments. The Body in mind training (BMT) is a treatment protocol that focuses on movement and motor system as a tool for mindfulness practice. More than three decades of studies have shown the positive effects of mindfulness based interventions (MBIs) in both mental and physical health and quality of life either in general population or clinical populations. Also, MBIs seem to be effective and a lasting alternative to treat anxiety. In relation to GAD, some studies have shown that MBI's are effective, but, in generally, they are limited by the small sample size or the use of waiting list control instead of an active control group.
So, the objective of this research is to evaluate the effectiveness of BMT intervention and compared to Fluoxetine and a Quality of Life Group in the treatment of GAD patients. Also, we intend to evaluate some biological and cognitive mechanisms of these different treatments through mediators analysis.
It is a single blind Randomized Controlled Trial with three arms of treatments. The individuals will be recruited in the community. Generalized Anxiety patients (according to Mini-International Neuropsychiatric Interview) will be randomly allocated (in a 1:1:1 ratio) to receive either antidepressant: BMT: Control Group. Research assessors will be masked. Because of the nature of the interventions, patients and clinicians will be aware of treatment allocation. The duration of the treatments is 8 weeks.
Before, in the week 5, and after the interventions, participants will be assessed with the Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression (CGI), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), Difficulties in Emotion Regulation Scale (DERS), Five Facet Mindfulness Questionnaire (FFMQ), Self-Compassion Scale (SCS), Action and Acceptance Questionnaire (AAQ), Ruminative Response Scale (RRS), Metacognition Questionnaire (MCQ-30), Meta-worry Questionnaire (MWQ), WHOQOL-Bref. Also, before the interventions, participants will answer the Early Life Experiences Scale (ELES) and Early Memories of Warmth and Safeness Scale (EMWSS). The HRV and ERN will be assessed before and after the interventions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- More than 18 years old;
- Primary Generalized Anxiety Disorder (GAD) according to M.I.N.I;
- Possibility to attend the Hospital every week during 8 weeks.
Exclusion Criteria:
- Current psychopharmacological or psychotherapeutic treatment for GAD;
- Previous no response treatment with fluoxetine for GAD;
- Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I);
- Hamilton Depression Scale (HAM-D) ≥23;
- Any contraindication to fluoxetine use;
- Clinical instability or immobility;
- Pregnancy or lactation;
- Antisocial Personality Disorder;
- Eating Disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Body in Mind Training (BMT)
This is a group intervention (10-15 participants) that consists of 5 weekly sessions lasting 2 hours.
In our protocol, we added 3 more final sessions of 2 hours in order to emphasize the practices, specially in self-compassion, resulting in 8 weeks of intervention.
|
Session 1 - Stop; Session 2 - Intention; Session 3 - Attention; Session 4 - Scientist Myself; Session 5 - Self-Compassion; Sessions 6, 7, 8 - Practice.
Other Names:
|
ACTIVE_COMPARATOR: Medication
In this group, individuals will consult with a psychiatrist weekly and will receive fluoxetine in a dosage of 20 to 60mg/dia according to clinical response.
|
In this group, individuals will consult with a psychiatrist weekly and will receive fluoxetine in a dosage of 20 to 60mg/dia according to clinical response.
Other Names:
|
ACTIVE_COMPARATOR: Quality of Life Group
This is a group intervention (10-15 participants) that consists of 8 weekly sessions lasting 2 hour in which individuals will receive psychoeducation on various aspects of quality of life that have na impact in reducing anxiety.
|
Session 1 - Psychoeducation; Session 2 - Substance Use; Session 3 - Sleep; Session 4 - Physical Exercise; Session 5 - Healthy Eating; Sessions 6, 7,8 - discussions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Penn State Worry Questionnaire (PSWQ) Score
Time Frame: Baseline , 8 weeks
|
Efficacy Assessment
|
Baseline , 8 weeks
|
Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score
Time Frame: Baseline , 8 weeks
|
Efficacy Assessment
|
Baseline , 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Heart Rate variability (HRV)
Time Frame: Baseline , 8 weeks
|
Biological Efficacy Assessment 1
|
Baseline , 8 weeks
|
Mean Change From Baseline in Error-Related Negativity (ERN)
Time Frame: Baseline , 8 weeks
|
Biological Efficacy Assessment 2
|
Baseline , 8 weeks
|
Mean Change From Baseline in Quality of Life (WHOQOL) Scores
Time Frame: Baseline , 8 weeks
|
Efficacy Assessment in Quality of Life
|
Baseline , 8 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Gisele Gus Manfro, Federal University of Rio Grande do Sul
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Disease
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- 160301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Generalized Anxiety Disorder
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
-
Xijing HospitalRecruitingGeneralized Anxiety DisorderChina
-
Sichuan Jishengtang Pharmaceutical Co., Ltd.Not yet recruitingGeneralized Anxiety Disorder
-
Hospital de Clinicas de Porto AlegreRecruitingGeneralized Anxiety DisorderBrazil
-
University of California, Los AngelesMedical University of South Carolina; Massachusetts General HospitalRecruitingGeneralized Anxiety DisorderUnited States
-
Shahid Beheshti University of Medical SciencesCompletedGeneralized Anxiety DisorderIran, Islamic Republic of
-
Dr. Nazanin AlaviOnline PsychoTherapy ClinicCompletedGeneralized Anxiety DisorderCanada
-
Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH)CompletedGeneralized Anxiety DisorderUnited States
-
The Canadian College of Naturopathic MedicineMassachusetts General Hospital; McGill University; Mitacs; Ekhagastiftelsen; Netherlands... and other collaboratorsActive, not recruitingGeneralized Anxiety DisorderCanada
Clinical Trials on Body in Mind Training (BMT)
-
Rutgers, The State University of New JerseyUniversity of California, Los Angeles; University of New MexicoActive, not recruitingKidney Cancer | Small Intestine Cancer | Lung Cancer | Prostate Cancer | Bladder Cancer | Colon Cancer | Thyroid Cancer | Rectum Cancer | Soft Tissue CancerUnited States
-
The Center for Mind-Body MedicineSimon Family FoundationEnrolling by invitation
-
Institut de Myologie, FranceEnrolling by invitationMyotonic Dystrophy Type 1France
-
Stanford UniversityNational Cancer Institute (NCI)WithdrawnBreast Cancer | Cancer Survivor | Cognitive/Functional EffectsUnited States
-
University of PittsburghWest Penn Allegheny Health SystemCompletedSystemic Lupus ErythematosusUnited States
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH); New York City Department for the...CompletedMental Health Disorder | Depression, UnipolarUnited States
-
Beth Israel Deaconess Medical CenterCompletedChronic Pain | Chronic Pain SyndromeUnited States
-
University of Colorado, BoulderCompletedEating Disorders in AdolescenceUnited States
-
Beth Israel Deaconess Medical CenterRecruiting
-
The Center for Mind-Body MedicineSilicon Valley Community FoundationCompleted