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

Not Applicable

Recruiting

• Conditions: OCD

• Registration Number: NCT06731426
• Lead Sponsor: Han Joo Lee

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-04-18
• Study First Submitted: 2024-11-21
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Thought-Action-Fusion Scale (TAFS) 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)	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.
Dimensional Obsessive-Compulsive Scale (DOCS) 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)	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).

Secondary Outcome Measures

Name	Time	Method
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)	Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995) is a 21-item self-report measure, which assesses symptoms of depression, anxiety, and stress. The measure uses a 4-point Likert scale, which ranges from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Higher scores indicate more severe depression, anxiety, and stress symptoms.

Trial Locations

Locations (1)

UWM Anxiety Disorders Laboratory; 🇺🇸 Milwaukee, Wisconsin, United States