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

NCT06731426 | Recruiting

• 1 other identifier: UWM 24.060
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

OCD

Keywords

Cognitive Bias Modification; Personalization

Outcome Measures

Primary Outcomes (2)

• Thought-Action-Fusion Scale (TAFS) at Pre-, Post-, and 1MFU

  The Thought-Action-Fusion Scale (TAFS; Shafran et al., 1996) is a 19-item measure, which assesses the presence and severity of TAF among adults. The measure uses a 5-point Likert scale, which ranges from 0 (Disagree Strongly) to 4 (Agree Strongly) with 12 items assessing TAF-moral, 3 items assessing TAF-likelihood-self, and 4 items assessing TAF-likelihood-others. The measure generates three scores (TAF-total, TAF-Moral, TAF-likelihood) and higher scores indicate higher severity.

  Pre-training (before 1st training session), Post-training (at the end of 6th training session, 3 weeks after the 1st training session on average), 1-Month Follow-Up (1 month after the 6th training session)

• Dimensional Obsessive-Compulsive Scale (DOCS) at Pre-, Post-, and 1MFU

  Dimensional Obsessive-Compulsive Scale (DOCS; Abramowitz et al., 2010) is a 20-item self-report measure, which assesses the severity of four dimensions of obsessive-compulsive symptoms among adults: 1) Concerns about Germs and Contamination, 2) Concerns about being Responsible for Harm, Injury, or Bad Luck, 3) Unacceptable thoughts (e.g., sex, immorality, violence), and 4) Concerns about Symmetry, Completeness, and the Need for Things to be "Just Right". The measure uses a 4-point Likert Scale, and the total score of DOCS ranges from 0 to 80. A cutoff score of 21 was established to distinguish individuals with clinically severe OC symptoms by the measure developers (Abramowitz et al., 2010).

  Pre-training (before 1st training session), Post-training (at the end of 6th training session, 3 weeks after the 1st training session on average), 1-Month Follow-Up (1 month after the 6th training session)

Secondary Outcomes (1)

• Depression, Anxiety, and Stress Scale (DASS-21) at Pre-, Post-, and 1MFU

  Pre-training (before 1st training session), Post-training (at the end of 6th training session, 3 weeks after the 1st training session on average), 1-Month Follow-Up (1 month after the 6th training session)

Study Arms (3)

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

EXPERIMENTAL

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).

Behavioral: CBM-TAF

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

ACTIVE COMPARATOR

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).

Behavioral: CBM-SMP

Waitlist (WL)

NO INTERVENTION

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

Interventions

CBM-TAF 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 Thought-Action-Fusion (CBM-TAF)

CBM-SMP 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Han Joo Lee: lead
• Psi Chi: collaborator

Study Sites (1)

UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, 53211, United States

RECRUITING

Related Publications (5)

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

  PMID: 11195984 BACKGROUND

• 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.

  PMID: 20230164 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

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

  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.

  BACKGROUND

Study Officials

• Hanjoo Lee, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanjoo Lee, PhD

CONTACT

(414) 229-5858; leehj@uwm.edu

Minjee Kook, BA

CONTACT

mkook@uwm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 12, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)