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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the effectiveness of exposure therapy for individuals with Obsessive Compulsive Disorder (OCD). Researchers seek to identify specific techniques during therapy sessions that lead to the best outcomes. Participants will undergo exposure therapy, which involves confronting anxiety triggers in a controlled manner, and will provide feedback on their experiences. The trial is suitable for adults with OCD seeking exposure therapy at McLean Hospital or San Diego State University. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve therapy techniques 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 prior data suggests that exposure therapy is safe for OCD patients?

Research has shown that exposure therapy, especially when combined with response prevention, is a proven treatment for obsessive-compulsive disorder (OCD). Studies have found it effective and generally safe in both hospital and outpatient settings. For example, one study found that this method helped patients manage their OCD symptoms well.

While exposure therapy is considered safe, some people might feel uncomfortable during sessions. This discomfort arises because the therapy involves facing things that trigger OCD symptoms. However, these feelings are usually temporary and are part of the process to help reduce anxiety over time.

Overall, exposure therapy is well-tolerated, and no significant evidence of long-term negative effects exists. For those considering joining a trial, it is reassuring to know that this treatment has a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to exposure therapy for OCD. Unlike standard treatments like cognitive-behavioral therapy with exposure and response prevention (ERP), this method involves developing exposure plans collaboratively with participants, tailoring the treatment to their specific needs. Additionally, the use of a wristwatch that gathers psychophysiological data is a novel feature, potentially offering real-time insights into patients' responses and allowing for more precise adjustments. This trial aims to refine exposure therapy practices, potentially enhancing its effectiveness and accessibility for individuals struggling with OCD.

What is the effectiveness track record for exposure therapy in treating OCD?

Research shows that exposure therapy, which participants in this trial will receive, effectively treats obsessive-compulsive disorder (OCD). Studies have found it greatly reduces OCD symptoms. One study found that symptoms improved significantly when exposure therapy was combined with medication, demonstrating a powerful combined approach. Another study found that exposure therapy alone had a moderate effect on reducing OCD symptoms. Overall, exposure therapy is a proven method, but there is still room for improvement for those who don't fully recover. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennie M Kuckertz, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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

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

I have been diagnosed with OCD.

You can understand and follow the study instructions in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

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]

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]

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]

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]

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]

Citations

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Exposure and response prevention for obsessive-compulsive ... Despite the success of ERP in treating OCD, there is room for improvement. As noted above, many people drop out of treatment prematurely and a substantial ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364922000355

Preliminary evidence for the effectiveness of concurrent ... These preliminary findings suggest that a concurrent approach to treating co-occurring OCD and PTSD is effective even with dynamic comorbidity.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834260

Exposure Therapy in Mixed Reality for Obsessive ... This evidence-based therapeutic approach has exhibited high effectiveness (Hedges g = 0.74) in reducing symptom severity and improving overall ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9520065/

The effectiveness of exposure and response prevention ... Patients with OCD have significant improvement in symptoms of obsessive-compulsive disorder and depression when ERP is combined with medication, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016517812200453X

The effect of exposure and response prevention therapy on ... The results showed that ERP had a definite effect on OCD (g = 0.37), and its effect was significant when the control condition was placebo (g = 0.97) or drug (g ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5031484/

Patient adherence and treatment outcome with exposure ... These data provide an efficient method for differentiating between those patients who will and will not achieve wellness after EX/RP augmentation of SRIs.

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-03701-z

effects of habituation and expectancy violation on short-term ... This study aimed to identify mechanisms of exposure with response prevention (ERP) that predict short-term outcomes in CBT for obsessive ...