Clinical trial NCT03921255: Cognitive Bias Modification for Thought-Action Fusion
Official title: Developing Interpretation Training for Modifying Thought Action Fusion Associated With Obsessive-compulsive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Thought-Action Fusion
Cognitive Bias Modification
Interpretation Training
Stress Management Psychoeducation
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three training groups, assessed at pre-training, post-training, and follow-up.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Thought-Action Fusion Scale (TAFS) across Pre-training, Post-training, and 1-Month follow-up
timeFrame: Pre-training, post-training (same day as pre-training), 1-Month Follow-up
Secondary outcomes:
measure: Change in Primary Obsession Evaluation of TAF Scale (POETS) across Pre-training, Post-training, and 1-Month follow-up
timeFrame: Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
measure: Change in Revised Obsessional Intrusions Inventory - Distress (ROII-Distress) across Pre-training, Post-training, and 1-Month follow-up
timeFrame: Pre-training, Post-training (same day as pre-training), 1-Month Follow-up
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: UWM Anxiety Disorders Laboratory
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Stephan Siwiec, M.S.
role: PRINCIPAL_INVESTIGATOR
References: