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

Trial Summary

What is the purpose of this trial?

This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I. Adults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.

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 data supports the effectiveness of the treatment Cognitive Bias Modification for Obsessive-Compulsive Disorder?

Research suggests that Cognitive Bias Modification (CBM) can help reduce OCD symptoms by changing how people interpret situations, and when combined with self-directed exposure therapy, it can be as effective as traditional therapist-led treatments. ^{1 2 3 4 5}

Is Cognitive Bias Modification safe for humans?

There is no specific safety data available for Cognitive Bias Modification, but it is generally considered safe as it is a non-invasive psychological intervention similar to other cognitive therapies. ^{1 2 3 6 7}

How is Psychoeducation different from other treatments for OCD?

Psychoeducation for OCD is unique because it focuses on educating patients about their condition and treatment options, which can empower them to manage their symptoms more effectively. Unlike traditional therapies that may involve direct exposure to fears, psychoeducation provides knowledge and understanding, which can be a less intimidating approach for some patients. ^{1 2 3 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Can the efficacy of behavioral and cognitive therapy for obsessive compulsive disorder be augmented by innovative computerized adjuvant?] [2018]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive Bias Modification (CBM) of obsessive compulsive beliefs. [2021]

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

Preliminary Evidence for the Enhancement of Self-Conducted Exposures for OCD using Cognitive Bias Modification. [2019]

4. Argentina pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

6. England 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). [2022]

7. 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]

8. Netherlands 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial. [2021]