Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil

August 8, 2024 updated by: Luciana Midori Samezima, Universidade Federal do Paraná

Group-based Acceptance and Commitment Therapy for Obsessive Compulsive Disorder: A Clinical Trial

The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults.

Researchers will compare intervention to control group to see if those who attend the group therapy have better results than control group.

Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).

  • Participants will not have any medication adjustment during therapy
  • Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT) + Exposure and Response Prevention (ERP) in Group is effective to Obsessive Compulsive Disorder (OCD) in adults. The main questions it aims to answer are:

  • Can ACT in groups help decrease the severity of OCD symptoms?
  • Can ACT in groups help increase psychological flexibility in this group?
  • Can ACT in groups help increase quality of life in this group?

Researchers will compare intervention (n=16) to control group (n=8) to see if those who attend the group therapy have better results than control group.

We will perform an unequal randomization in a 2:1 ratio, in blocks of 6, for allocation to each group. The assessor of the outcomes of interest will be blinded to the group to which the participant was assigned

Participants will go through a 16-week group therapy based on a protocol designed by Michael Twohig (Twohig et al, 2018).

  • Participants will not have any medication adjustment during therapy
  • Participants will be assessed 3 times throughout the therapy, plus an assessment in a 6-month follow-up.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
        • Universidade Federal do Paraná

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • OCD diagnosis according to DMS-5/ Minimum score of 20 in YBOCS

Exclusion Criteria:

  • Psychotic disorder, maniac episode, intellectual disability, Chemical dependency, Suicidal risk, another current psychotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group psychotherapy with ACT
16 sessions of group psychotherapy based on ACT + exposure with response prevention (EPR)
Other: Group acceptance and commitment therapy (ACT)
Group psychotherapy based on ACT + EPR
Other Names:
  • Psychotherapy
  • Acceptance and Commitment Therapy
  • Group Psychotherapy
No Intervention: Treatment as usual
Patients will follow their usual treatment, without adding ACT-based group psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Measure for assessing the presence and severity of obsessive-compulsive disorder (OCD) symptoms.
10 months (4-month intervention + 6-month follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance and Commitment Therapy Processes (CompACT)
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Measure of psychological flexibility
10 months (4-month intervention + 6-month follow-up)
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV)
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of dally functioning
10 months (4-month intervention + 6-month follow-up)
Depression Anxiety and Stress Scale (DASS)
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Set of self-report scales designed to measure the emotional states of depression, anxiety and stress.
10 months (4-month intervention + 6-month follow-up)
AAQ for Obsessions and Compulsions (AAQ-OC)
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Self-report measure of experiential avoidance in response to unwanted intrusive thoughts.
10 months (4-month intervention + 6-month follow-up)
Affective Style Questionnaire (ASQ)
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Brief instrument to measure individual differences in emotion regulation
10 months (4-month intervention + 6-month follow-up)
Clinical Global Impressions (CGI) Scale,
Time Frame: 10 months (4-month intervention + 6-month follow-up)
Quantify and track patient progress and treatment response over time.
10 months (4-month intervention + 6-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Paraná

Investigators

  • Principal Investigator: Gabriela M Ferreira, MD, PhD, Universidade Federal do Paraná

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61795622.3.0000.0096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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