Cognitive Bias Modification for Thought-Action Fusion

NCT03921255 | Completed

• 1 other identifier: TAF Extended
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Thought-Action Fusion; Cognitive Bias Modification; Interpretation Training; Stress Management Psychoeducation

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  Pre-training, Post-training (same day as pre-training), 1-Month Follow-up

Study Arms (3)

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.

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.

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.

Other: Cognitive Bias Modification

Interventions

Cognitive Bias Modification OTHER

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).

Also known as: Interpretation Training

Stress Management Psychoeducation; TAF Congruent (TAF-CON); TAF Incongruent (TAF-INC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

UWM Anxiety Disorders Laboratory

Milwaukee, Wisconsin, 53211, United States

Location

Related Links

• UWM Anxiety Disorders Lab Website
• UWM SONA Portal to Prescreen Information

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Stephan Siwiec, M.S.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three training groups, assessed at pre-training, post-training, and follow-up.

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: April 19, 2019
• Study Start: April 10, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)