Clinical trial NCT06731426: Multi-session, Personalized Cognitive Bias Modification for Thought-Action-Fusion
Official title: Effects of Multi-session, Personalized Cognitive Bias Modification for Thought-Action-Fusion Among Adults with Obsessive-Compulsive Symptoms: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OCD
Keywords: Cognitive Bias Modification
Personalization
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Psi Chi
First posted: 2024-12-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thought-Action-Fusion Scale (TAFS) at Pre-, Post-, and 1MFU
timeFrame: 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)
measure: Dimensional Obsessive-Compulsive Scale (DOCS) at Pre-, Post-, and 1MFU
timeFrame: 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:
measure: Depression, Anxiety, and Stress Scale (DASS-21) at Pre-, Post-, and 1MFU
timeFrame: 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)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: UWM Anxiety Disorders Laboratory
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Hanjoo Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shafran R, Thordarson DS, Rachman S. Thought-action fusion in obsessive compulsive disorder. Journal of Anxiety Disorders. 1996; 10(5), 379-391.
citation: 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.