Cognitive Bias Modification for Obsessive-Compulsive Disorder

Overseen By Minjee Kook, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Han Joo Lee

Disqualifiers: Visual impairment, Bipolar, Psychotic, 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: 7

Duration: 3 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with obsessive-compulsive disorder (OCD) by targeting a specific thinking pattern called thought-action-fusion (TAF). TAF involves the belief that having certain thoughts equates to acting on them or that these thoughts will increase the likelihood of events occurring. The trial compares two types of cognitive exercises: one focuses on changing TAF (Cognitive Bias Modification for Thought-Action-Fusion, or CBM-TAF), and the other on stress management. Participants experiencing OCD symptoms and able to use a smartphone might be suitable candidates.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could lead to new treatment options 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.

What prior data suggests that this cognitive bias modification is safe for treating obsessive-compulsive disorder?

Research shows that Cognitive Bias Modification (CBM) methods, like those in this trial, are generally easy for people to handle. CBM aims to change certain thought patterns that might lead to mental health issues. This trial focuses on Thought-Action-Fusion (TAF) for people with Obsessive-Compulsive Disorder (OCD).

Previous studies have shown that CBM-TAF treatment is safe and has few side effects. Participants in these studies completed the tasks without major problems, making it a promising way to change harmful thinking patterns.

Similarly, the CBM-SMP treatment, which focuses on stress management, has been used in different settings to help people manage anxiety and stress. This approach is gentle and has not been linked to any serious side effects.

Both treatments involve simple tasks like completing sentences, making them low-risk and easy for most participants. This makes joining the trial a safe option for those interested in exploring new ways to manage OCD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Bias Modification for Obsessive-Compulsive Disorder trial because it explores innovative methods to address OCD. Unlike traditional treatments like cognitive-behavioral therapy (CBT) or medications such as SSRIs, this trial uses targeted techniques to change how individuals process thoughts, specifically focusing on thought-action fusion (TAF). The CBM-TAF approach involves engaging participants in an interactive task that helps them reinterpret ambiguous scenarios, potentially leading to quicker and more direct modifications in cognitive biases related to OCD. Additionally, the trial includes a stress management component, CBM-SMP, which offers a fresh perspective on managing stress, a common trigger for OCD symptoms. Researchers hope these methods might offer more engaging and rapid relief compared to current options.

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

This trial will compare Cognitive Bias Modification for Thought-Action-Fusion (CBM-TAF) with Cognitive Bias Modification for Stress Management Psychoeducation (CBM-SMP) and a waitlist control. Research has shown that CBM-TAF can reduce symptoms of obsessive-compulsive disorder (OCD) by altering negative thinking patterns related to OCD. It encourages participants to rethink thoughts that lead to obsessive thinking, focusing on changing interpretations of unclear situations, which can lessen the intensity of their obsessions.

For CBM-SMP, research indicates it can also alter biased thinking linked to mental health issues, including OCD. CBM-SMP focuses on managing stress, helping individuals change their reactions to stress. This approach can improve mental well-being by addressing stress-related thought patterns. ^{1 2 6 7 8}

Who Is on the Research Team?

Hanjoo Lee, PhD

Principal Investigator

University of Wisconsin, Milwaukee

Are You a Good Fit for This Trial?

This trial is for college individuals with Obsessive-Compulsive Disorder (OCD) who experience Thought-Action-Fusion, where they believe unwanted thoughts are morally wrong or likely to become real. Specific eligibility criteria details were not provided.

Inclusion Criteria

A score of 18 or higher on the Dimensional Obsessive-Compulsive Scale (DOCS)

Access to a mobile device (i.e., smartphone)

Exclusion Criteria

Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen

Self-reported history of a bipolar disorder or psychotic disorder on a Diagnostic History Scale (DHS)

Inability to adequately understand the study procedure as determined by the responses to comprehension questions provided at the time of the consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 6 training sessions over 3 weeks, focusing on cognitive bias modification for Thought-Action-Fusion or stress management

3 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CBM-SMP
• CBM-TAF

Trial Overview The study tests a personalized cognitive bias modification program targeting Thought-Action-Fusion biases in OCD patients. It aims to see if changing these thought patterns can improve OCD symptoms over multiple sessions.

How Is the Trial Designed?

Group I: Cognitive Bias Modification for Thought-Action-Fusion (CBM-TAF) Experimental Treatment 1 Intervention

CBM-TAF will employ an ambiguous sentence-completion task, where participants have to fill in a missing letter in a fragmented word and resolve emotional ambiguity of a given scenario. At the beginning of each training session, participants will watch a brief animated video about TAF, OCD, and modifying TAF. Each training session will consist of 40 scenarios, which will take about 20 minutes to complete. There will be a total of 6 sessions (2x/week for 3 weeks).

Group II: Cognitive Bias Modification for Stress Management Psychoeducation (CBM-SMP) Active Control 1 Intervention

Similar to CBM-TAF, CBM-SMP will employ an ambiguous sentence-completion task, where participants have to fill in a missing letter in a fragmented word. However, the content of scenarios in CBM-SMP will focus on general stress management techniques. At the beginning of each training session, participants will watch a brief animated video about OCD and stress management techniques. Each training session will consist of 40 scenarios, which will take about 20 minutes to complete. There will be a total of 6 sessions (2x/week for 3 weeks).

Group III: Waitlist (WL) Active Control 1 Intervention

Participants in WL group will only complete weekly assessment measures without engaging in any training sessions.

Who Is Running the Clinical Trial?

Han Joo Lee

Lead Sponsor

Trials

1

Recruited

80+

Psi Chi

Collaborator

Trials

6

Recruited

350+

Psi Chi

Collaborator

Trials

6

Recruited

350+

Published Research Related to This Trial

The Attention and Interpretation Modification (AIM) treatment, which combines Cognitive Bias Modification for attention and interpretation, significantly reduced social anxiety symptoms in participants compared to a placebo, as measured by self-reports and behavioral performance.

Participants found AIM to be moderately credible and acceptable, with a preference for the interpretation modification component over the attention modification, suggesting that this combined approach could be a promising and accessible treatment for Social Anxiety Disorder if validated in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined cognitive bias modification treatment for social anxiety disorder: a pilot trial. Beard, C., Weisberg, RB., Amir, N.[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]

This study is the first to evaluate Cognitive Bias Modification for Interpretation (CBM-I) as an adjunctive treatment for adults undergoing intensive/residential treatment for obsessive-compulsive and related disorders (OCRDs), involving 31 participants in a pilot randomized controlled trial.

The results showed that the CBM-I group had a large effect on changing interpretation bias (d = 0.90), while the psychoeducation group had a trivial effect (d = 0.06), indicating that CBM-I is both feasible and acceptable in this setting and may enhance treatment outcomes for OCRDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Cognitive Bias Modification for Interpretation as an Adjunctive Treatment for OCD and Related Disorders: A Pilot Randomized Controlled Trial. Falkenstein, MJ., Kelley, KN., Dattolico, D., et al.[2022]

Cognitive bias modification (CBM) is a promising psychological intervention aimed at correcting harmful cognitive processes linked to various psychiatric disorders, including anxiety and depression.

The review outlines a four-step translational process for CBM research, emphasizing the need for reliable cognitive targets, effective clinical translations, verification of engagement, and testing in randomized controlled trials to establish CBM as an evidence-supported therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From cognitive targets to symptom reduction: overview of attention and interpretation bias modification research. Gober, CD., Lazarov, A., Bar-Haim, Y.[2023]

Cognitive bias modification (CBM) techniques have been shown to effectively change attentional and interpretive biases linked to various psychological issues, including anxiety disorders and addictions, indicating their potential therapeutic impact.

Recent studies suggest that extended use of CBM can reduce symptoms of anxiety and enhance treatment outcomes for conditions like alcohol dependence, but further large-scale trials are needed to confirm these findings and optimize integration into treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive bias modification procedures in the management of mental disorders. Macleod, C.[2022]

Cognitive bias modification (CBM) has been shown to effectively retrain implicit biases, leading to clinically relevant changes in behaviors associated with anxiety, depression, and addiction, as evidenced by 13 studies reviewed.

The integration of neuroimaging techniques with CBM research has advanced our understanding of the neural mechanisms involved, highlighting the potential for CBM to influence mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging the neural effects of cognitive bias modification training. Wiers, CE., Wiers, RW.[2018]

Cognitive bias modification (CBM) interventions show only small effects on anxiety and depression, with many results being non-significant in patient samples, indicating limited clinical relevance.

The review of 49 randomized controlled trials revealed that the quality of studies was suboptimal, and potential publication bias may inflate perceived benefits, suggesting that more rigorous research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive bias modification interventions in anxiety and depression: meta-analysis. Cristea, IA., Kok, RN., Cuijpers, P.[2022]

Interpretive cognitive bias modification (CBM-I) training, especially with positive imagery, may help reduce memory distrust and intolerance of uncertainty in individuals, suggesting a potential new approach for addressing symptoms of OCD.

Participants who underwent positive imagery CBM-I training showed a more adaptive interpretation of ambiguous checking scenarios and reported fewer negative checking beliefs, although behavioral checking tasks did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagery versus verbal interpretive cognitive bias modification for compulsive checking. Black, MJ., Grisham, JR.[2019]

Cognitive bias modification (CBM) shows promise as a treatment for anxiety disorders, with participants finding the rationale for the treatment relevant and helpful, indicating potential acceptability.

However, participants expressed confusion about the effectiveness of the attention modification program, suggesting that improvements in the treatment's rationale and credibility are needed to enhance understanding and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socially anxious primary care patients' attitudes toward cognitive bias modification (CBM): a qualitative study. Beard, C., Weisberg, RB., Primack, J.[2021]

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]

Citations

1. 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 ...

2. withpower.com withpower.com/trial/cognitive-bias-modification-for-obsessive-compulsive-disorder-ae327

Cognitive Bias Modification for Obsessive-Compulsive ... Research shows that Cognitive Bias Modification (CBM) can help change biased thinking patterns linked to various mental health issues, including obsessive- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364923000088

Cognitive bias modification for thought-action fusion CBM-I reduces maladaptive bias by guiding participants to alter negatively biased interpretations of ambiguous information and endorse adaptive alternatives.

4. 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.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-193

Internet-based cognitive bias modification for obsessive ... Cognitive bias modification (CBM) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0005796724000846

Towards implementation of cognitive bias modification in ... Cognitive bias modification (CBM) has evolved from an experimental method testing cognitive mechanisms of psychopathology to a promising tool for accessible ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3092585/

Cognitive bias modification for anxiety: current evidence ... Cognitive bias modification (CBM) is an innovative approach to modifying cognitive biases that confer vulnerability to anxiety.

8. cdasr.mclean.harvard.edu cdasr.mclean.harvard.edu/wp-content/uploads/2021/11/Falkenstein-et-al.pdf

Feasibility and acceptability of cognitive bias modification ... Cognitive models implicate interpretation bias in the development and maintenance of obsessive compulsive and related disorders (OCRDs), and research supports ...