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

Trial Summary

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

Research shows that Cognitive Bias Modification (CBM) can help change biased thinking patterns linked to various mental health issues, including obsessive-compulsive disorder (OCD). Studies have found that CBM can effectively target and modify interpretation biases, which are thought to play a role in maintaining OCD symptoms. ^{1 2 3 4 5}

Is Cognitive Bias Modification (CBM) safe for humans?

The available research does not specifically address the safety of Cognitive Bias Modification (CBM) for humans, but it is generally used in clinical settings for various mental health conditions, suggesting it is considered safe. ^{1 5 6 7 8}

How is the treatment CBM-TAF different from other treatments for OCD?

CBM-TAF is unique because it focuses on changing the way people interpret their thoughts and actions through computerized tasks, aiming to reduce biased thinking patterns associated with OCD. Unlike traditional therapies, it uses technology to 're-train' the brain's automatic responses, potentially offering a new way to address the underlying cognitive biases in OCD. ^{1 3 4 9 10}

What is the purpose of this trial?

Thought-Action-Fusion (TAF) is a cognitive bias that posits (1) having unwanted thoughts is morally equivalent to acting upon the thoughts (TAF-Moral; e.g., "Thinking about harming a child is as immoral as actually harming a child") and (2) having unwanted thoughts will increase the likelihood of the thoughts happening in real life (TAF-Likelihood; e.g., "My mother will get into a car accident, because I thought about it"). Given its central role in the development and maintenance of OCD, TAF has emerged as a potential treatment target for obsessive-compulsive disorder (OCD). Previous research has demonstrated that TAF is indeed a malleable construct. This study aims to examine the effects of a multi-session, personalized cognitive bias modification (CBM) for thought-action-fusion (TAF) on improving obsessive-compulsive (OC) symptoms in a college sample.

Research Team

Hanjoo Lee, PhD

Principal Investigator

University of Wisconsin, Milwaukee

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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) 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 (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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

From cognitive targets to symptom reduction: overview of attention and interpretation bias modification research. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2022]

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

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

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

Socially anxious primary care patients' attitudes toward cognitive bias modification (CBM): a qualitative study. [2021]

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

Efficacy of cognitive bias modification interventions in anxiety and depression: meta-analysis. [2022]

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

Combined cognitive bias modification treatment for social anxiety disorder: a pilot trial. [2021]

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

Imaging the neural effects of cognitive bias modification training. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Imagery versus verbal interpretive cognitive bias modification for compulsive checking. [2019]