- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03921255
Cognitive Bias Modification for Thought-Action Fusion (TAF)
January 20, 2022 updated by: Han Joo Lee, University of Wisconsin, Milwaukee
Developing Interpretation Training for Modifying Thought Action Fusion Associated With Obsessive-compulsive Symptoms
An important cognitive bias in many emotional disorders, particularly obsessive-compulsive disorder (OCD), is thought-action fusion (TAF).
TAF describes the bias to interpret the presence of unwanted mental intrusions as morally equivalent to acting on them (TAF-M), and/or increasing the likelihood of the feared consequence occurring to either oneself (TAF-LS) or others (TAF-LO).
The present study is designed to test the feasibility of a single session computerized cognitive bias modification for interpretations (CBM-I) to reduce TAF among individuals who reported obsessional intrusions.
Participants will be randomized to (a) the TAF-incongruent condition (TAF-INC), designed to decrease TAF linked to obsessional thoughts, to (b) the TAF-congruent condition (TAF-CON), designed to render TAF-like interpretation of obsessional thoughts unchallenged, or to (c) a Stress Management Psychoeducation (SMP) condition, designed to provide information about stress reduction, but not target TAF directly.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Individuals who display at least mild obsessional and TAF symptoms will be invited to the current study.
Participants will be randomized to one of the three interpretation training conditions: an TAF-INC, TAF-CON, or SMP.
Before and after the training, participants will complete some self-report questionnaires and clinician administered measures.
The computerized training will provide statements intended to activate the mechanisms involved in thought-action-fusion (TAF), which will almost always produce a negative outcome interpretation.
It is hypothesized that through TAF-INC participants will learn alternative, more neutral, ways of interpreting the thoughts and lower the subject's TAF.
The TAF-CON condition will receive the same statements as TAF-INC, but TAF-CON is designed to leave the interpretation of the scenarios unchallenged.
The study will also include another comparison condition, SMP, to test if TAF-INC outperforms not only TAF-CON, but also stress reduction techniques provided in empirically supported psychological treatment.
The SMP training will be similar in procedure and structure to the other two conditions, but it will provide psychoeducation about stress and stress management techniques.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53211
- UWM Anxiety Disorders Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- UWM undergraduates who were at least 18 years old who (i) score of at least 1 [A Little (Distressed or Bothered)] on the OCI-R obsessing subscale, and (ii) at least one TAFS item scored 3 (Agree) or 4 (Agree Strongly) were be eligible to participate in the study. A score of 1 or higher on the obsessing subscale of the OCI-R indicates the presence of obsessional intrusions, and was used as a cutoff in previous research (Siwiec et al., 2017). A score of 3 or above on an item of the TAFS indicates the participant agrees with and holds some pronounced TAF bias.
Exclusion Criteria:
- Individuals whose primary language is not English will not be included in the study. Assessment and training programs are all written in English (we are not able to present a version in another language) - it is important for participants to understand subtlety of slightly varying vignettes in the training program.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TAF Incongruent (TAF-INC)
Active condition (TAF-INC) cognitive bias modification for interpretations (CBM-I), incorporates an obsessional thought meant to elicit either moral or likelihood TAF, followed by a sentence incongruent to TAF bias and meant to reduce the impact of the previous statement.
Before moving on, participants must fill-in and correctly solve a key word important in the interpretation of the sentence.
Participants then must correctly solve a short yes/no comprehension question to ensure understanding of the scenario.
|
There is support that CBM-I may work through the process of cognitive restructuring, and specifically, threat reappraisal.
Threat appraisal is a tendency to overestimate the likelihood of harm (i.e., likelihood bias) and/or the negative consequences of anticipated harm (i.e., Clark & Beck, 2010), producing avoidance, thus interfering with effectively reappraising threat, thereby creating a vicious cycle (Beck et al., 1985; Clark & Beck, 2010).
CBM-I procedures ensure that an interpretation bias is triggered by the ambiguous scenarios, and participants are then guided to solve the key word in accordance with a healthy response (Grey & Mathews, 2000).
The observed effects of CBM-I may stem from active generation of benign or positive meanings in response to ambiguous situations, where threats were previously interpreted (Beadel et al., 2014).
Other Names:
|
Placebo Comparator: TAF Congruent (TAF-CON)
Maintenance/Control condition (TAF-CON) CBM-I, differs in that participants are provided with a sentence congruent with TAF bias.
Again, participants were only able to move on when they correctly solved the key word and the accompanying yes/no comprehension question.
|
There is support that CBM-I may work through the process of cognitive restructuring, and specifically, threat reappraisal.
Threat appraisal is a tendency to overestimate the likelihood of harm (i.e., likelihood bias) and/or the negative consequences of anticipated harm (i.e., Clark & Beck, 2010), producing avoidance, thus interfering with effectively reappraising threat, thereby creating a vicious cycle (Beck et al., 1985; Clark & Beck, 2010).
CBM-I procedures ensure that an interpretation bias is triggered by the ambiguous scenarios, and participants are then guided to solve the key word in accordance with a healthy response (Grey & Mathews, 2000).
The observed effects of CBM-I may stem from active generation of benign or positive meanings in response to ambiguous situations, where threats were previously interpreted (Beadel et al., 2014).
Other Names:
|
Placebo Comparator: Stress Management Psychoeducation
In the stress management psychoeducation (SMP) psychoeducation about stress and stress management are provided, similar in length to the obsessional thought and interpretations presented in the TAF-INC and TAF-CON.
Like the other conditions there is a key word to solve, and participants were only able to move on when they correctly solved the key word and the accompanying yes/no comprehension question.
|
There is support that CBM-I may work through the process of cognitive restructuring, and specifically, threat reappraisal.
Threat appraisal is a tendency to overestimate the likelihood of harm (i.e., likelihood bias) and/or the negative consequences of anticipated harm (i.e., Clark & Beck, 2010), producing avoidance, thus interfering with effectively reappraising threat, thereby creating a vicious cycle (Beck et al., 1985; Clark & Beck, 2010).
CBM-I procedures ensure that an interpretation bias is triggered by the ambiguous scenarios, and participants are then guided to solve the key word in accordance with a healthy response (Grey & Mathews, 2000).
The observed effects of CBM-I may stem from active generation of benign or positive meanings in response to ambiguous situations, where threats were previously interpreted (Beadel et al., 2014).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Thought-Action Fusion Scale (TAFS) across Pre-training, Post-training, and 1-Month follow-up
Time Frame: Pre-training, post-training (same day as pre-training), 1-Month Follow-up
|
The Thought-Action-Fusion Scale (TAFS; Shafran et al., 1996) is a 19-item measure which assesses the degree to which importance and responsibility is lent to a variety of intrusive and distressing thoughts containing moral and likelihood themes.
The measure uses a 5-point scale ranging from 0 (Disagree Strongly), to 4 (Agree Strongly).
There are no cutoff scores but higher TAFS scores are indicative of higher rates of TAF cognitions (Shafran et al., 1996).
In student and community samples the three-scale model (TAF-M, TAF-LS, TAF-LO) has displayed moderate to strong association between the scales (r=.25 - .69;
Abramowitz et al., 2003; Bailey et al., 2014; Coles, Mennin, & Heimberg, 2001; Rassin, Merkelbach et al., 2001).
|
Pre-training, post-training (same day as pre-training), 1-Month Follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Primary Obsession Evaluation of TAF Scale (POETS) across Pre-training, Post-training, and 1-Month follow-up
Time Frame: Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
|
The Primary Obsession Evaluation of TAF Scale (POETS; Siwiec et al., 2017) is designed to assess the participant's TAF emotional and cognitive reactions toward a specific (primary) obsessional intrusion.
A study clinician helps identify their primary obsessive thought using the Y-BOCS Obsession Checklist.
The POETS uses a 7-point scale from 0 (Not Distressing at All), to 6 (Extremely Distressing), and incorporates 3 domains (5 questions each): (1) General Emotional Reactions, (2) Moral TAF, and (3) Likelihood TAF.
The general emotional reaction domain gauges discomfort with the presence of the thought, the moral domain gauges the moral implications of the thought, and the likelihood domain gauges the belief to which the event will occur because of the thought.
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Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
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Change in Revised Obsessional Intrusions Inventory - Distress (ROII-Distress) across Pre-training, Post-training, and 1-Month follow-up
Time Frame: Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
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The Revised Obsessional Intrusions Inventory - Distress (ROII-Distress) is a 52-item self-report measure, modified (Siwiec et al., 2017) from the original ROII (Purdon & Clark, 1993, 1994), to assess how distressing various intrusive thoughts, images, and impulses would be to the participant in the event of their intrusion.
The measure uses a 7-point scale from 0 (Not Distressing), to 6 (Extremely Distressing).
Unlike the original ROII, the ROII-Distress does not use a time frame as the obsessive thoughts, images, or impulses may not have occurred yet, but asks instead of distress if the thought were to occur.
In consideration of heterogeneity in obsessional intrusions across individuals, we computed an idiographic distress index, consisting of the 10-highest endorsed ROII-Distress items for each participant at pre-training.
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Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephan Siwiec, M.S., University of Wisconsin, Milwaukee
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2016
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
March 10, 2019
First Submitted That Met QC Criteria
April 16, 2019
First Posted (Actual)
April 19, 2019
Study Record Updates
Last Update Posted (Actual)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAF Extended
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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