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

NCT03072264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

  • Generalized Anxiety Disorder

Interventions

BEHAVIORAL

Body in Mind Training (BMT)

Session 1 - Stop; Session 2 - Intention; Session 3 - Attention; Session 4 - Scientist Myself; Session 5 - Self-Compassion; Sessions 6, 7, 8 - Practice.

DRUG

Fluoxetine

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.

BEHAVIORAL

Quality of Life Group

Session 1 - Psychoeducation; Session 2 - Substance Use; Session 3 - Sleep; Session 4 - Physical Exercise; Session 5 - Healthy Eating; Sessions 6, 7,8 - discussions.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Gisele Gus Manfro · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072264 on ClinicalTrials.gov