Randomized Clinical Trial of a Mindfulness Based Intervention in Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The literature suggests that Mindfulness Based Intervention may be effective in the treatment of anxiety symptoms. The objective of this study is to compare the clinical effectiveness of a Mindfulness Based Intervention - the Mind in Body Training (MBT) - with a selective serotonin reuptake inhibitor (Fluoxetine) and an active control group (Quality of Life) through different biological and clinical outcomes, as well as evaluate some possible mechanisms of treatment response. Methods: it is a three armed randomized, controlled clinical trial. Participants with General Anxiety Disorder will be recruited. A community sample of 192 participants will be randomly allocated to the MBT, Fluoxetine or Quality of Life Group. Instruments measuring anxiety, worry and meta-worry symptoms, quality of life, acceptance and self-compassion, mindfulness, rumination and emotion regulation will be applied. The patients will be submitted to Error Related Negativity (ERN) and Heart Rate Variability (HRV) measures. The primary outcome is the effectiveness of MBT compared with Fluoxetine and Quality of Life Group in symptomatic outcomes. The secondary outcome are the effectiveness os these interventions in emotional regulation process and biological measures (ERN and HRV), and the evaluation of BMT mechanisms through possible mediation of treatment response for emotional processes like mindfulness, acceptance and self-compassion, biological changes (ERN and HRV), and metacognition.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Fluoxetine

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.