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NCT Number: NCT06548893

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal Do Paraná

Curitiba, Paraná, 80060-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group acceptance and commitment therapy (ACT)

Other

Group psychotherapy based on ACT + EPR

Other names: Group Psychotherapy, Acceptance and Commitment Therapy, Psychotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Acceptance and Commitment Therapy Processes (CompACT)

    Time frame: 10 months (4-month intervention + 6-month follow-up)

    Measure of psychological flexibility

  2. 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

  3. 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.

  4. 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.

  5. Affective Style Questionnaire (ASQ)

    Time frame: 10 months (4-month intervention + 6-month follow-up)

    Brief instrument to measure individual differences in emotion regulation

  6. 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Paraná

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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