Exposure Therapy for OCD

Recruiting at 1 trial location

Overseen By Jennie M Kuckertz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: Psychosis, Suicidality, Inpatient need, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Exposure therapy is the most effective treatment available for obsessive compulsive disorder, yet up to 50% of patients do not recover because the mechanisms underlying successful response are poorly understood, leading to significant variability in how clinicians conduct exposure therapy. The main purpose of this study is to determine which target mechanisms are most critical to engage in real-world exposure sessions to produce good treatment outcomes. Adult participants (N = 400) with Obsessive Compulsive Disorder (OCD) receiving exposure therapy from two sites (McLean Hospital, San Diego State University) across the continuum of care (outpatient, partial hospital, residential) will complete baseline clinical and demographic measures as well as weekly symptom reports. The project will measure exposure mechanisms across three levels of analysis (self-report, observer-rated behavior, physiology) during each exposure session. Mechanisms assessed will include a broad range of variables based on both habituation and inhibitory learning models of exposure. Self-report and observer-rated mechanisms will be measured with the Exposure Feedback Form, created and piloted by the study team. Physiological mechanisms will include skin conductance response, heart rate, and heart rate variability measured with a wristwatch. The current study will determine (1) which exposure mechanisms lead to favorable clinical outcomes, and (2) what makes a good exposure for whom. Results of this study have the potential to improve personalized care for the many patients who do not remit following exposure therapy for OCD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Exposure Therapy for OCD?

Research shows that exposure therapy, specifically exposure and response prevention (ERP), is effective for treating OCD. Studies indicate significant improvements in OCD symptoms, with long-term benefits when exposure exercises are maintained. ^{1 2 3 4 5}

Is exposure therapy generally safe for humans?

Research shows that exposure-based therapy, including for OCD, is generally safe and does not lead to more negative outcomes compared to other treatments. Concerns about negative reactions are common, but studies do not support these fears, and expert recommendations endorse its use. ^{2 6 7 8 9}

How is Exposure Therapy different from other treatments for OCD?

Exposure Therapy for OCD is unique because it involves facing fears directly and preventing the usual compulsive responses, which helps reduce anxiety over time. Unlike some other treatments, it can be delivered in a concentrated group format over a few days, making it more accessible and cost-effective. ^{2 10 11 12 13}

Research Team

Jennie M Kuckertz, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

This trial is for adults aged 18-65 with Obsessive Compulsive Disorder (OCD) who are seeking exposure therapy at McLean Hospital OCD Institute or San Diego State University. Participants must be able to complete study measures and treatment procedures in English.

Inclusion Criteria

I am between 18 and 65 years old.

You are currently receiving treatment at the McLean Hospital OCD Institute or San Diego State University.

I have been diagnosed with OCD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete exposure therapy for up to 12 weeks, with each session approximately 50 minutes long. Exposure plans are developed collaboratively and refined iteratively.

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exposure Therapy

Trial Overview The study aims to identify key mechanisms that make exposure therapy effective for treating OCD by analyzing self-reported data, observer-rated behavior, and physiological responses like heart rate during therapy sessions.

Participant Groups

Group I: Exposure therapy Experimental Treatment 1 Intervention

Participants will complete exposure therapy for up to 12 weeks, and each coached exposure session will be approximately 50 minutes. Exposure plans will be developed collaboratively between participants and their clinician at the beginning of treatment, and refined iteratively as clinically appropriate. In each coached exposure, participants will: 1. Complete an Exposure Feedback Form 2. Wear a wristwatch that provides psychophysiological data The intervention will occur across two study sites (McLean Hospital, San Diego State University). Sites will differ on level of care. At McLean Hospital, participants will be recruited from the OCD Institute and will receive exposure therapy via partial hospital or residential setting as part of their standard care, regardless of participation in the study. At San Diego State University, participants will be recruited to receive exposure therapy via outpatient setting.

Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Findings from Research

A study of 30 patients who underwent 12 weeks of intensive inpatient cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) showed significant long-term improvements in obsessive-compulsive disorder (OCD) symptoms, with 20% achieving remission 8-10 years post-treatment.

Continuing exposure exercises after the inpatient treatment was identified as a key factor for maintaining these improvements, suggesting that ongoing practice is essential for long-term success in managing OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder: Symptom Severity and the Role of Exposure 8-10 Years After Inpatient Treatment. Külz, AK., Landmann, S., Schmidt-Ott, M., et al.[2021]

In a study involving 42 OCD patients, Concentrated Exposure Treatment (cET) led to a significant reduction in OCD symptoms, with 74% of participants achieving remission immediately after treatment and 60% maintaining recovery at a 6-month follow-up.

The treatment was well-received, showing high patient satisfaction, and the effectiveness of cET was successfully replicated with a new group of therapists, indicating its potential for broader use in treating OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrated ERP Delivered in a Group Setting: A Replication Study. Havnen, A., Hansen, B., Öst, LG., et al.[2022]

A meta-analysis of 13 trials showed that group cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for obsessive-compulsive disorder (OCD), with a strong pre-post effect size of 1.18.

Group CBT/ERP outperformed waiting list controls and achieved better results than pharmacological treatments in some studies, indicating its efficacy as a psychological intervention for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. Jónsson, H., Hougaard, E.[2018]

Exposure with response prevention (ERP) is established as the first-line psychotherapeutic treatment for obsessive-compulsive disorder (OCD), showing significant efficacy in reducing symptoms.

Combining ERP with cognitive therapy (CT) can enhance treatment outcomes by improving distress tolerance and adherence, suggesting that a tailored approach may be beneficial for patients with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for obsessive-compulsive disorder. McKay, D., Sookman, D., Neziroglu, F., et al.[2022]

Exposure and response prevention (ERP) therapy was effective for an 80-year-old man with a 65-year history of obsessive-compulsive disorder (OCD), showing a 65% reduction in clinician-based Y-BOCS scores after 14 treatment sessions.

The patient also experienced a 45% decrease in OCI-R scores, indicating significant improvement in OCD symptoms, suggesting that ERP can be a viable treatment option for older adults with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of exposure and response prevention for geriatric obsessive compulsive disorder: a clinical case illustration. Jones, MK., Wootton, BM., Vaccaro, LD.[2021]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

Exposure-based cognitive-behavioral therapy (CBT) for pediatric obsessive-compulsive disorder (OCD) does not lead to negative outcomes such as treatment attrition, poor therapeutic relationships, or low treatment satisfaction when compared to nonexposure-based treatments.

These findings support expert recommendations for using exposure-based CBT in treating pediatric OCD, helping to alleviate clinician concerns about potential adverse effects on patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Perspective: Exposures in cognitive behavior therapy for pediatric obsessive-compulsive disorder: addressing common clinician concerns. McGuire, JF., Wu, MS., Choy, C., et al.[2019]

Serious negative consequences (SNC) from exposure and response prevention (ERP) therapy for obsessive-compulsive disorder (OCD) are extremely rare, occurring in only 0.05% of adult clients and 0.01% of youth clients, indicating that ERP is a safe treatment option.

Despite some therapists' concerns, the study found that most therapists are willing to treat harm-related OCD, and improving communication about the safety and rationale of ERP could enhance access to this effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. Schneider, SC., Knott, L., Cepeda, SL., et al.[2020]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

A 10-session group therapy for obsessive-compulsive disorder (OCD) was effective, showing a significant reduction in symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale, with scores decreasing from 21.8 to 16.6 after treatment.

This group therapy approach offers a practical alternative to traditional individual therapy, addressing the challenges of limited access to trained therapists and the high costs associated with intensive individual treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A time-limited behavioral group for treatment of obsessive-compulsive disorder. Van Noppen, BL., Pato, MT., Marsland, R., et al.[2018]

Exposure therapy with response prevention is considered the most effective treatment for obsessive-compulsive disorder (OCD), highlighting its importance in managing this condition.

This therapy has been successfully applied to both outpatient and inpatient settings, demonstrating its versatility and effectiveness across different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Obsessive-compulsive disorders--inpatient behavior therapy]. Winkelmann, G., Hohagen, F.[2006]

A survey of 216 German therapists revealed that while most consider exposure with response prevention (ERP) an effective treatment for obsessive-compulsive disorder (OCD), many do not implement it due to factors like patient motivation and organizational difficulties.

Differences were noted between physicians and psychologists, with physicians using ERP less frequently and preferring self-help methods, highlighting a need for improved adherence to treatment guidelines for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Phobie à deux" and other reasons why clinicians do not apply exposure with response prevention in patients with obsessive-compulsive disorder. Moritz, S., Külz, A., Voderholzer, U., et al.[2020]

The article highlights that while exposure and response prevention (ERP) therapy is effective for OCD, some patients do not respond well or may relapse after treatment ends, indicating a need for enhanced approaches.

The authors propose a couple-based treatment program that includes partner-assisted exposure therapy and interventions to address relationship dynamics, which may improve ERP outcomes for individuals with OCD in long-term relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing exposure and response prevention for OCD: a couple-based approach. Abramowitz, JS., Baucom, DH., Wheaton, MG., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder: Symptom Severity and the Role of Exposure 8-10 Years After Inpatient Treatment. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Concentrated ERP Delivered in a Group Setting: A Replication Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for obsessive-compulsive disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy of exposure and response prevention for geriatric obsessive compulsive disorder: a clinical case illustration. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Editorial Perspective: Exposures in cognitive behavior therapy for pediatric obsessive-compulsive disorder: addressing common clinician concerns. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Serious negative consequences associated with exposure and response prevention for obsessive-compulsive disorder: A survey of therapist attitudes and experiences. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A time-limited behavioral group for treatment of obsessive-compulsive disorder. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[Obsessive-compulsive disorders--inpatient behavior therapy]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

"Phobie à deux" and other reasons why clinicians do not apply exposure with response prevention in patients with obsessive-compulsive disorder. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Enhancing exposure and response prevention for OCD: a couple-based approach. [2013]