Obsessive-Compulsive DisorderNCT06548893
Acceptance and Commitment Therapy (ACT) in Groups for Obsessive Compulsive Disorder: A Clinical Trial in Brazil
A study testing Group acceptance and commitment therapy (ACT) in people with Obsessive-Compulsive Disorder, run by Universidade Federal do Paraná at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Group acceptance and commitment therapy (ACT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2022to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OCD diagnosis according to DMS-5/ Minimum score of 20 in YBOCS
Who cannot join
- Psychotic disorder, maniac episode, intellectual disability, Chemical dependency, Suicidal risk, another current psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Group acceptance and commitment therapy (ACT)
- Keywords
- OCD, Obsessive-compulsive disorder
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group acceptance and commitment therapy (ACT)Other
Also called Group Psychotherapy, Acceptance and Commitment Therapy, Psychotherapy
Group psychotherapy based on ACT + EPR
| Study group | Role | What they receive |
|---|---|---|
| Group psychotherapy with ACT | Experimental | 16 sessions of group psychotherapy based on ACT + exposure with response prevention (EPR) Receives: Other: Group acceptance and commitment therapy (ACT) |
| Treatment as usual | No intervention | Patients will follow their usual treatment, without adding ACT-based group psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Measure for assessing the presence and severity of obsessive-compulsive disorder (OCD) symptoms.
Measured: 10 months (4-month intervention + 6-month follow-up)
Secondary outcomes (6)
Acceptance and Commitment Therapy Processes (CompACT)
Measure of psychological flexibility
Measured: 10 months (4-month intervention + 6-month follow-up)
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-SV)
Measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of dally functioning
Measured: 10 months (4-month intervention + 6-month follow-up)
Depression Anxiety and Stress Scale (DASS)
Set of self-report scales designed to measure the emotional states of depression, anxiety and stress.
Measured: 10 months (4-month intervention + 6-month follow-up)
AAQ for Obsessions and Compulsions (AAQ-OC)
Self-report measure of experiential avoidance in response to unwanted intrusive thoughts.
Measured: 10 months (4-month intervention + 6-month follow-up)
Affective Style Questionnaire (ASQ)
Brief instrument to measure individual differences in emotion regulation
Measured: 10 months (4-month intervention + 6-month follow-up)
Clinical Global Impressions (CGI) Scale,
Quantify and track patient progress and treatment response over time.
Measured: 10 months (4-month intervention + 6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start10 Aug 2022
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Midori Samezima, Universidade Federal do Paraná
- Investigators
- Gabriela M Ferreira, MD, PhD, Principal investigator, Universidade Federal do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548893
- Sponsor's protocol ID
- 61795622.3.0000.0096
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29966992
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Acceptance and Commitment Therapy for Obsessive Compulsive Disorder: A Clinical Trial
- ClinicalTrials.gov ID
- NCT06548893
- Acronym / sponsor ID
- 61795622.3.0000.0096
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, Obsessive-compulsive disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group psychotherapy with ACT | Experimental | Other: Group acceptance and commitment therapy (ACT)16 sessions of group psychotherapy based on ACT + exposure with response prevention (EPR) |
| Treatment as usual | No intervention | –Patients will follow their usual treatment, without adding ACT-based group psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OCD diagnosis according to DMS-5/ Minimum score of 20 in YBOCS
Key exclusion criteria (1 listed)
- Psychotic disorder, maniac episode, intellectual disability, Chemical dependency, Suicidal risk, another current psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group acceptance and commitment therapy (ACT)Also: Group Psychotherapy, Acceptance and Commitment Therapy, PsychotherapyGroup psychotherapy based on ACT + EPR | Other | Group psychotherapy with ACT |
Primary outcome
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.
6 secondary outcomes
Acceptance and Commitment Therapy Processes (CompACT)
Time frame: 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)
Depression Anxiety and Stress Scale (DASS)
Time frame: 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)
Affective Style Questionnaire (ASQ)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 29966992Twohig 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.
- ACT+ERP for OCD: This is a 16-session twice-weekly therapist manual for OCD describing ERP conducted from an ACT framework.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela M Ferreira, MD, PhD principal investigator
Universidade Federal do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group acceptance and commitment therapy (ACT) in people with Obsessive-Compulsive Disorder, run by Universidade Federal do Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (YBOCS) (time frame: 10 months (4-month intervention + 6-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06548893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.