Cognitive Bias Modification for Obsessive-Compulsive Disorder

Overseen By Martha Falkenstein, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: Psychosis, Psychotic disorder

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

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital training called Cognitive Bias Modification for Interpretation (CBM-I) to assist individuals with obsessive-compulsive disorder (OCD). The goal is to determine if this tool can alter thought patterns by practicing tasks that may alleviate OCD symptoms. Participants will be divided into two groups: one will use the CBM-I tool, while the other will receive standard psychoeducational therapy sessions for comparison. The study seeks adults with OCD who are part of a treatment program for the disorder. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance OCD treatment options.

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 seems likely that you can continue your usual treatment, as the study is an addition to standard OCD treatment.

What prior data suggests that this digital intervention is safe for OCD patients?

Research has shown that Cognitive Bias Modification for Interpretation (CBM-I) is generally safe. Although specific safety data for CBM-I is lacking, it involves a digital training task that alters how individuals interpret information. This non-invasive training does not involve physical procedures and is intended to complement regular treatment for obsessive-compulsive disorder (OCD). Participants in similar techniques have not reported major side effects, suggesting that CBM-I is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Bias Modification for Obsessive-Compulsive Disorder (OCD) because it offers a fresh approach by targeting interpretation bias, a cognitive distortion often linked to OCD symptoms. Unlike traditional treatments like cognitive-behavioral therapy (CBT) and medications that focus on managing symptoms or altering behavior, this method directly addresses the underlying cognitive biases contributing to the disorder. By providing digital cognitive training, it allows for a personalized and potentially more accessible intervention, which could enhance the effectiveness of standard treatment options. This innovative approach holds promise for improving outcomes for individuals with OCD.

What evidence suggests that this trial's treatments could be effective for OCD?

Research has shown that Cognitive Bias Modification for Interpretation (CBM-I), a treatment in this trial, might help reduce obsessive-compulsive beliefs by altering how individuals interpret information. Studies have found that online CBM-I training can benefit people with OCD, particularly by reducing negative thoughts. Previous trials suggest that CBM-I effectively targets obsessive-compulsive beliefs, helping to change them positively. These findings indicate that CBM-I could improve symptoms in people with OCD by directly addressing and altering harmful thought patterns. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a primary diagnosis of OCD, confirmed by specific clinical assessments. Participants must be able to complete computer tasks and consent to the main study protocol. Those with acute psychosis or a psychotic disorder cannot join.

Inclusion Criteria

Consent to main OCD Institute study protocol

Score of >131 on the Obsessive Beliefs Questionnaire-44 at admission [which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)]

I can use a computer for 20 minutes without a break.

Exclusion Criteria

I have been diagnosed with a psychotic disorder.

I am currently experiencing severe symptoms of psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 12 sessions of Cognitive Bias Modification for Interpretation (CBM-I) or psychoeducation as a control condition

8 weeks

12 sessions (digital)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive bias modification for interpretation bias
• Psychoeducation

Trial Overview The trial tests Cognitive Bias Modification for Interpretation (CBM-I), a digital intervention aimed at changing interpretation bias in OCD patients, against psychoeducation. It will assess CBM-I's feasibility, acceptability, and impact on OCD when added to usual treatment.

How Is the Trial Designed?

Group I: Cognitive bias modification with treatment as usual Experimental Treatment 1 Intervention

Participants in this group will receive usual treatment in the program up to 12 sessions of a digital cognitive training targeting interpretation bias

Group II: Psychoeducation with treatment as usual Placebo Group 1 Intervention

Participants in this group will receive usual treatment in the program up to 12 sessions of digitized psychoeducation

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Published Research Related to This Trial

This study is a randomized clinical trial comparing family-based cognitive behavioral therapy (FCBT) to family-based psychoeducation and relaxation training (FPRT) in children and adolescents aged 8-17 with obsessive-compulsive disorder (OCD), aiming to include at least 128 participants to ensure robust results.

The trial is designed to minimize bias and enhance the reliability of findings by using blinding for assessors and randomizing therapists to deliver both interventions, allowing for a clearer understanding of the specific benefits and harms of FCBT compared to FPRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial). Pagsberg, AK., Uhre, C., Uhre, V., et al.[2022]

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]

A 7-week treatment program combining self-directed Exposure and Response Prevention (sERP) with Cognitive Bias Modification (CBM) significantly reduced OCD symptoms in 22 participants, showing promise as an accessible alternative to traditional ERP.

The effectiveness of this integrated approach was comparable to standard clinician-administered ERP, suggesting that initial clinician guidance may be sufficient for patients to benefit from self-directed treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for the Enhancement of Self-Conducted Exposures for OCD using Cognitive Bias Modification. Amir, N., Kuckertz, JM., Najmi, S., et al.[2019]

Using standardized Jacobson methodology, exposure and response prevention (ERP) was found to be the most effective psychological treatment for OCD, with 50-60% of patients achieving recovery.

However, when defining recovery based on being asymptomatic, both ERP and cognitive therapy showed low recovery rates of about 25%, highlighting the importance of the criteria used to measure treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective are cognitive and behavioral treatments for obsessive-compulsive disorder? A clinical significance analysis. Fisher, PL., Wells, A.[2022]

In a pilot study involving 16 adolescents with OCD, the addition of online Cognitive Bias Modification training (CBM-I) to standard treatment (Cognitive Behavioral Therapy and pharmacotherapy) led to a significant reduction in obsessive-compulsive symptoms, indicating its potential as an effective adjunctive treatment.

The study showed that while immediate interpretations improved with CBM-I training, no changes were observed in the placebo group, suggesting that CBM-I may specifically target cognitive biases associated with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentation of Treatment As Usual with online Cognitive Bias Modification of Interpretation training in adolescents with Obsessive Compulsive Disorder: A pilot study. Salemink, E., Wolters, L., de Haan, E.[2019]

Overvalued ideas in Obsessive Compulsive Disorder (OCD), such as excessive responsibility and perfectionism, significantly hinder treatment progress, especially for exposure and response prevention (ERP) interventions.

Cognitive change through education and disputing maladaptive thoughts is crucial for symptom remission, making cognitive therapy and ERP the preferred treatment methods for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioural therapy of overvalued ideas in patients suffering of obsessive-compulsive disorder]. Spinetto, M.[2018]

A randomized trial with 35 patients showed that both standard cognitive behavioral therapy (CBT) and an experimental CBT with a computerized psychoeducative tool led to significant improvements in obsessive-compulsive disorder (OCD) symptoms, with similar reductions in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores (48% vs 45%).

While the computerized tool was well-received by patients and therapists, it did not enhance the overall effectiveness of CBT, indicating that while it may be a useful addition, it does not replace the core therapeutic benefits of standard CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] Morgiève, M., N'Diaye, K., Clair, AH., et al.[2018]

Cognitive bias modification training (CBM-I) effectively shifted interpretation biases in individuals with obsessive compulsive symptoms, leading to more positive interpretations of OC-related scenarios compared to a control group of 89 participants.

Participants who underwent the positive CBM-I training reported reduced distress and urges to neutralize after facing OC stressors, suggesting potential therapeutic benefits, although further research in clinical samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Bias Modification (CBM) of obsessive compulsive beliefs. Williams, AD., Grisham, JR.[2021]

This randomized controlled trial aims to evaluate the efficacy of an internet-delivered cognitive bias modification (CBM) intervention for obsessive-compulsive disorder (OCD) with a sample size of 35 participants to account for potential dropouts.

The study will assess changes in cognitive biases and OCD-related beliefs using various standardized measures, with follow-up assessments planned to evaluate the stability of any observed changes over one month.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial. Williams, AD., Pajak, R., O'Moore, K., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2211364923000301

Who benefits? Examining the role of OCD severity ... An online CBM-I training designed to reduce dysfunctional interpretations in youth with Obsessive Compulsive Disorder (OCD) had therapeutic benefits on OCD ...

2. withpower.com withpower.com/trial/phase-obsessive-compulsive-disorder-2-2022-95370

Cognitive Bias Modification for Obsessive-Compulsive Disorder Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.Adults with obsessive compulsive disorder (OCD) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3851748/

Cognitive Bias Modification (CBM) of obsessive compulsive ... CBM-I appears effective in selectively targeting OC beliefs. Results need to be replicated in clinical samples in order for potential therapeutic benefit to be ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06941155

Gamified Combined Cognitive Bias Modification in Adults ... This randomized controlled trial examines the effects of a mobile-based gamified combined cognitive bias modification (CBM-C) intervention on ...

5. researchgate.net researchgate.net/publication/257597810_Cognitive_Bias_Modification_CBM_of_obsessive_compulsive_beliefs

(PDF) Cognitive Bias Modification (CBM) of obsessive ... Severity of OC symptoms did not moderate the effects of positive CBM-I training. CBM-I appears effective in selectively targeting OC beliefs.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05224414

Interpretation Bias as a Mechanism of Treatment Response ... This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005791619301429

A randomised controlled trial of computerised interpretation ... This study is the first to evaluate the effect of internet-delivered CBM-I training targeting benign interpretations of bodily symptoms on health anxiety.