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

NCT03072264 | Completed

• 1 other identifier: 160301
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Generalized Anxiety Disorder, GAD, mindfulness, anxiety

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Penn State Worry Questionnaire (PSWQ) Score

  Efficacy Assessment

  Baseline , 8 weeks

• Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score

  Efficacy Assessment

  Baseline , 8 weeks

Secondary Outcomes (3)

• Mean Change From Baseline in Heart Rate variability (HRV)

  Baseline , 8 weeks

• Mean Change From Baseline in Error-Related Negativity (ERN)

  Baseline , 8 weeks

• Mean Change From Baseline in Quality of Life (WHOQOL) Scores

  Baseline , 8 weeks

Study Arms (3)

Body in Mind Training (BMT)

EXPERIMENTAL

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.

Behavioral: Body in Mind Training (BMT)

Medication

ACTIVE COMPARATOR

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.

Drug: Fluoxetine

Quality of Life Group

ACTIVE COMPARATOR

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.

Behavioral: Quality of Life Group

Interventions

Body in Mind Training (BMT) BEHAVIORAL

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

Also known as: Mindfulness Based Intervention

Body in Mind Training (BMT)

Fluoxetine DRUG

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.

Also known as: Control Group

Medication

Quality of Life Group BEHAVIORAL

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

Also known as: Control Group

Quality of Life Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

• Costa MA, Goncalves FG, Tatton-Ramos T, Fonseca NKOD, Schwinn JK, Alves SG, Salum GA, Manfro GG. A Three-Arm Randomized Clinical Trial Comparing the Efficacy of a Mindfulness-Based Intervention with an Active Comparison Group and Fluoxetine Treatment for Adults with Generalized Anxiety Disorder. Psychother Psychosom. 2021;90(4):269-279. doi: 10.1159/000511880. Epub 2020 Dec 15.

  PMID: 33321509 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Fluoxetine; Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gisele Gus Manfro

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: March 7, 2017
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 27, 2019

Record last verified: 2018-08

Locations

BR (1)