Randomized Clinical Trial of a Mindfulness Based Intervention in Generalized Anxiety Disorder
Generalized Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, GAD, mindfulness, anxiety
Eligibility Criteria
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.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Body in Mind Training (BMT)
Medication
Quality of Life Group
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.
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.
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.