Obsessive-Compulsive DisorderTAFNCT03921255
Cognitive Bias Modification for Thought-Action Fusion
A study testing Cognitive Bias Modification in people with Obsessive-Compulsive Disorder, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Bias Modification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UWM Anxiety Disorders Laboratory
Milwaukee, Wisconsin, 53211
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive Bias Modification
- Keywords
- Thought-Action Fusion, Cognitive Bias Modification, Interpretation Training, Stress Management Psychoeducation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias ModificationOther
Also called Interpretation Training
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).
| Study group | Role | What they receive |
|---|---|---|
| TAF Incongruent (TAF-INC) | Active comparator | 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. Receives: Other: Cognitive Bias Modification |
| TAF Congruent (TAF-CON) | Placebo comparator | 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. Receives: Other: Cognitive Bias Modification |
| Stress Management Psychoeducation | Placebo comparator | 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. Receives: Other: Cognitive Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thought-Action Fusion Scale (TAFS) across Pre-training, Post-training, and 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).
Measured: Pre-training, post-training (same day as pre-training), 1-Month Follow-up
Secondary outcomes (2)
Change in Primary Obsession Evaluation of TAF Scale (POETS) across Pre-training, Post-training, and 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.
Measured: Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
Change in Revised Obsessional Intrusions Inventory - Distress (ROII-Distress) across Pre-training, Post-training, and 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.
Measured: Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start10 Apr 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three training groups, assessed at pre-training, post-training, and follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
- Investigators
- Stephan Siwiec, M.S., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921255
- Sponsor's protocol ID
- TAF Extended
- Acronym
- TAF
- Status last verified
- Jan 2022
- First submitted
- 10 Mar 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Interpretation Training for Modifying Thought Action Fusion Associated With Obsessive-compulsive Symptoms
- ClinicalTrials.gov ID
- NCT03921255
- Acronym / sponsor ID
- TAF / TAF Extended
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Thought-Action Fusion, Cognitive Bias Modification, Interpretation Training, Stress Management Psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three training groups, assessed at pre-training, post-training, and follow-up.
| Arm | Type | Receives |
|---|---|---|
| TAF Incongruent (TAF-INC) | Active comparator | Other: Cognitive Bias ModificationActive 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. |
| TAF Congruent (TAF-CON) | Placebo comparator | Other: Cognitive Bias ModificationMaintenance/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. |
| Stress Management Psychoeducation | Placebo comparator | Other: Cognitive Bias ModificationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Bias ModificationAlso: Interpretation TrainingThere 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 | Stress Management Psychoeducation, TAF Congruent (TAF-CON), TAF Incongruent (TAF-INC) |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- UWM Anxiety Disorders Lab WebsiteLink provided by the sponsor.
- UWM SONA Portal to Prescreen InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Siwiec, M.S. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification in people with Obsessive-Compulsive Disorder, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.