Multi-session, Personalized Cognitive Bias Modification for Thought-Action-Fusion

NCT ID: NCT06731426

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-18

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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All participants will be randomized into three groups: 1) CBM-TAF, 2) CBM-SMP (stress management psychoeducation), and 3) WL (waitlist). Participants randomized into either of the training groups (CBM-TAF or CBM-SMP) will complete a total of 6 training sessions (2x/week for 3 weeks), which employ the ambiguous-sentence completion task. To strengthen the training effect, participants will watch brief animated videos about TAF (CBM-TAF) or stress management (CBM-SMP) at the beginning of each session. Participants randomized into the WL group will only complete weekly assessments without any training sessions. All participants will complete pre-, post-training and 1-month follow-up assessments. All training sessions and assessments will be housed on a mobile-based web platform.

Conditions

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OCD

Keywords

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Cognitive Bias Modification Personalization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Bias Modification for Thought-Action-Fusion (CBM-TAF)

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 Type EXPERIMENTAL

CBM-TAF

Intervention Type BEHAVIORAL

CBM-TAF aims to modify TAF by training participants to adopt an interpretation style that is inconsistent with TAF (i.e., having unwanted thoughts is not morally equivalent to acting upon them and/or having unwanted thoughts does not increase the likelihood of feared events happening in real life). To personalize the training, CBM-TAF is designed to address 4 subtypes of OCD (as defined by Dimensional Obsessive-Compulsive Scale; Abramowitz et al., 2010), each of which targets either TAF-moral or TAF-likelihood. Participants will indicate two OCD subtypes that are most relevant to their experiences and only complete scenarios that correspond to their chosen subtypes. For each scenario, participants are instructed to enter a missing letter in a fragmented word and resolve its emotional ambiguity. After then, participants will answer a True/False question related to the given scenario to verify their comprehension and consolidate their acquisition of healthier interpretation style.

Cognitive Bias Modification for Stress Management Psychoeducation (CBM-SMP)

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 Type ACTIVE_COMPARATOR

CBM-SMP

Intervention Type BEHAVIORAL

CBM-SMP is a comparable intervention to CBM-TAF (Siwiec et al., 2023), which aims to provide general education about stress and stress management techniques. It is identical to CBM-TAF in terms of its administration, except for the content of scenarios included in training sessions. For each scenario, participants are instructed to enter a missing letter in a fragmented word. After then, participants will answer a True/False question related to the given scenario in order to verify their comprehension.

Waitlist (WL)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CBM-TAF

CBM-TAF aims to modify TAF by training participants to adopt an interpretation style that is inconsistent with TAF (i.e., having unwanted thoughts is not morally equivalent to acting upon them and/or having unwanted thoughts does not increase the likelihood of feared events happening in real life). To personalize the training, CBM-TAF is designed to address 4 subtypes of OCD (as defined by Dimensional Obsessive-Compulsive Scale; Abramowitz et al., 2010), each of which targets either TAF-moral or TAF-likelihood. Participants will indicate two OCD subtypes that are most relevant to their experiences and only complete scenarios that correspond to their chosen subtypes. For each scenario, participants are instructed to enter a missing letter in a fragmented word and resolve its emotional ambiguity. After then, participants will answer a True/False question related to the given scenario to verify their comprehension and consolidate their acquisition of healthier interpretation style.

Intervention Type BEHAVIORAL

CBM-SMP

CBM-SMP is a comparable intervention to CBM-TAF (Siwiec et al., 2023), which aims to provide general education about stress and stress management techniques. It is identical to CBM-TAF in terms of its administration, except for the content of scenarios included in training sessions. For each scenario, participants are instructed to enter a missing letter in a fragmented word. After then, participants will answer a True/False question related to the given scenario in order to verify their comprehension.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* A score of 18 or higher on the Dimensional Obsessive-Compulsive Scale (DOCS)
* Aged 18 or higher
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psi Chi

OTHER

Sponsor Role collaborator

Han Joo Lee

OTHER

Sponsor Role lead

Responsible Party

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Han Joo Lee

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hanjoo Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

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UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hanjoo Lee, PhD

Role: CONTACT

Phone: (414) 229-5858

Email: [email protected]

Minjee Kook, BA

Role: CONTACT

Email: [email protected]

Facility Contacts

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Hanjoo Lee, PhD

Role: primary

Minjee Kook, BA

Role: backup

Hanjoo Lee, Ph.D.

Role: backup

References

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Mathews A, Mackintosh B. Induced emotional interpretation bias and anxiety. J Abnorm Psychol. 2000 Nov;109(4):602-15.

Reference Type BACKGROUND
PMID: 11195984 (View on PubMed)

Abramowitz JS, Deacon BJ, Olatunji BO, Wheaton MG, Berman NC, Losardo D, Timpano KR, McGrath PB, Riemann BC, Adams T, Bjorgvinsson T, Storch EA, Hale LR. Assessment of obsessive-compulsive symptom dimensions: development and evaluation of the Dimensional Obsessive-Compulsive Scale. Psychol Assess. 2010 Mar;22(1):180-98. doi: 10.1037/a0018260.

Reference Type BACKGROUND
PMID: 20230164 (View on PubMed)

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

Reference Type BACKGROUND
PMID: 7726811 (View on PubMed)

Shafran R, Thordarson DS, Rachman S. Thought-action fusion in obsessive compulsive disorder. Journal of Anxiety Disorders. 1996; 10(5), 379-391.

Reference Type BACKGROUND

Siwiec S, Bodhy S, Lotfi S, Lee, HJ. Cognitive bias modification for thought-action fusion: A placebo-controlled randomized experimental trial. Journal of Obsessive-Compulsive and Related Disorders. 2023; 37, 100787.

Reference Type BACKGROUND

Other Identifiers

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UWM 24.060

Identifier Type: -

Identifier Source: org_study_id