Clinical trial NCT06548893: Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil
Official title: Group-based Acceptance and Commitment Therapy for Obsessive Compulsive Disorder: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Obsessive-compulsive disorder
Lead sponsor: Universidade Federal do Paraná
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale (YBOCS)
timeFrame: 10 months (4-month intervention + 6-month follow-up)
Secondary outcomes:
measure: Acceptance and Commitment Therapy Processes (CompACT)
timeFrame: 10 months (4-month intervention + 6-month follow-up)
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV)
timeFrame: 10 months (4-month intervention + 6-month follow-up)
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: 10 months (4-month intervention + 6-month follow-up)
measure: AAQ for Obsessions and Compulsions (AAQ-OC)
timeFrame: 10 months (4-month intervention + 6-month follow-up)
measure: Affective Style Questionnaire (ASQ)
timeFrame: 10 months (4-month intervention + 6-month follow-up)
measure: Clinical Global Impressions (CGI) Scale,
timeFrame: 10 months (4-month intervention + 6-month follow-up)
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Universidade Federal Do Paraná
state: Parana
Study officials:
affiliation: Universidade Federal do Paraná
name: Gabriela M Ferreira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.