Cognitive Bias Modification for Thought-Action Fusion (TAF)
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ClinicalTrials.gov Identifier: NCT03921255 |
Recruitment Status :
Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Obsessive-Compulsive Disorder | Other: Cognitive Bias Modification | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Three training groups, assessed at pre-training, post-training, and follow-up. |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Participants are randomized to one of three training conditions. The randomized training assignment is unknown to the participant and assessor by using code names for the training conditions. |
Primary Purpose: | Treatment |
Official Title: | Developing Interpretation Training for Modifying Thought Action Fusion Associated With Obsessive-compulsive Symptoms |
Actual Study Start Date : | April 10, 2016 |
Estimated Primary Completion Date : | August 31, 2019 |
Estimated Study Completion Date : | August 31, 2019 |

Arm | Intervention/treatment |
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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.
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Other: Cognitive Bias Modification
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 Name: Interpretation Training |
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.
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Other: Cognitive Bias Modification
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 Name: Interpretation Training |
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.
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Other: Cognitive Bias Modification
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 Name: Interpretation Training |
- 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).
- 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.
- 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 ]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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921255
Contact: Han Joo Lee, Ph.D. | 414-229-5858 | leehj@uwm.edu | |
Contact: Stephan Siwiec, M.S. | 414-229-5941 | sgsiwiec@uwm.edu |
United States, Wisconsin | |
UWM Anxiety Disorders Laboratory | Recruiting |
Milwaukee, Wisconsin, United States, 53211 | |
Contact: Hanjoo Lee, Ph.D. | |
Principal Investigator: Hanjoo Lee, Ph.D. |
Principal Investigator: | Stephan Siwiec, M.S. | University of Wisconsin, Milwaukee |
Responsible Party: | Han Joo Lee, Associate Professor, University of Wisconsin, Milwaukee |
ClinicalTrials.gov Identifier: | NCT03921255 |
Other Study ID Numbers: |
TAF Extended |
First Posted: | April 19, 2019 Key Record Dates |
Last Update Posted: | April 19, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thought-Action Fusion Cognitive Bias Modification Interpretation Training Stress Management Psychoeducation |
Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders |