NCT06548893

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Aug 2022Jun 2026

Study Start

First participant enrolled

August 10, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

August 8, 2024

Last Update Submit

August 8, 2024

Conditions

Keywords

OCDObsessive-compulsive disorder

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive-Compulsive Scale (YBOCS)

    Measure for assessing the presence and severity of obsessive-compulsive disorder (OCD) symptoms.

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

Secondary Outcomes (6)

  • Acceptance and Commitment Therapy Processes (CompACT)

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

  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV)

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

  • Depression Anxiety and Stress Scale (DASS)

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

  • AAQ for Obsessions and Compulsions (AAQ-OC)

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

  • Affective Style Questionnaire (ASQ)

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

  • +1 more secondary outcomes

Study Arms (2)

Group psychotherapy with ACT

EXPERIMENTAL

16 sessions of group psychotherapy based on ACT + exposure with response prevention (EPR)

Other: Group acceptance and commitment therapy (ACT)

Treatment as usual

NO INTERVENTION

Patients will follow their usual treatment, without adding ACT-based group psychotherapy

Interventions

Group psychotherapy based on ACT + EPR

Also known as: Group Psychotherapy, Acceptance and Commitment Therapy, Psychotherapy
Group psychotherapy with ACT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal Do Paraná

Curitiba, Paraná, 80060-900, Brazil

Location

Related Publications (1)

  • Twohig MP, Abramowitz JS, Smith BM, Fabricant LE, Jacoby RJ, Morrison KL, Bluett EJ, Reuman L, Blakey SM, Ledermann T. Adding acceptance and commitment therapy to exposure and response prevention for obsessive-compulsive disorder: A randomized controlled trial. Behav Res Ther. 2018 Sep;108:1-9. doi: 10.1016/j.brat.2018.06.005. Epub 2018 Jun 22.

    PMID: 29966992BACKGROUND

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psychotherapy, GroupAcceptance and Commitment TherapyPsychotherapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyBehavioral Disciplines and ActivitiesCognitive Behavioral TherapyBehavior Therapy

Study Officials

  • Gabriela M Ferreira, MD, PhD

    Universidade Federal do Paraná

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only the team member who will apply the questionnaires/scales will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

August 10, 2022

Primary Completion

June 20, 2025

Study Completion (Estimated)

June 20, 2026

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations