Imagery Enhanced Cognitive Bias Modification for Chronic Worry

NCT03855488 | Suspended

• 1 other identifier: REB 2018-394
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

People who experience high levels of worry often have mental habits that fuel their worry. One mental habit of interest to researchers is the tendency to assess situations and experiences in a very negative way even when it is possible the situation may turn out to be neutral or even positive. Cognitive bias modification of interpretations (CBM-I) is a training that is designed to target the tendency to catastrophize and jump to negative conclusions when faced with ambiguous information. CBM-I has been shown to improve this habit as well as anxiety and low mood. In this experiment, the investigators are looking to enhance CBM-I for pathological worry. Specifically, the investigators are testing the immediate and short-term effects of using imagery when completing CBM-I.

Conditions

Excessive Worry

Keywords

Worry; Anxiety; Imagery; Cognitive bias modification

Outcome Measures

Primary Outcomes (2)

• Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version

  Self-report measure assessing the degree of excessive worry experienced over the past week. The measure contains 15 items and scores range from 0 to 90, with greater scores indicating a greater degree of worry.

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at 1-week and 2-week follow-ups.

• Change in self-reported interpretation bias as measured by Ambiguous/ Unambiguous Situations Diary Extended

  Self-report measure of interpretation bias that contains 55 vignettes describing a positive, negative, or ambiguous scenario. For each scenario, participants are instructed to rate their level of concern on a scale from 1 to 5, with higher scores indicating greater concern. Greater concern for ambiguous scenarios suggests greater interpretation bias.

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.

Secondary Outcomes (6)

• Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale.

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.

• Quality of problem solving as measured by the Means-Ends Problem-Solving task

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.

• Self-reported vividness, arousal, and likelihood of positive and negative prospective scenarios as measured by the Prospective Imagery Task

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.

• Interpretation bias as measured by the Word-Sentence Association Paradigm

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.

• Self-reported negative thought intrusions as measured by the Breathing Focus Task

  Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.

Other Outcomes (1)

• Self reported belief that the training will improve worry as measured by the Credibility Expectancy Check (CEQ)

  Administered on day 1 prior to completing the intervention (pre-intervention) following the explanation of the intervention and the rationale.

Study Arms (3)

Standard cognitive bias modification

EXPERIMENTAL

Listen to descriptions of ambiguous scenarios that resolve positively

Behavioral: Standard cognitive bias modification

Imagery enhanced cognitive bias modification

EXPERIMENTAL

Listen to descriptions of ambiguous scenarios that resolve positively while engaging in imagery

Behavioral: Imagery enhanced cognitive bias modification

Neutral Control Condition

PLACEBO COMPARATOR

Listen to descriptions of neutral scenarios

Behavioral: Neutral Control Condition

Interventions

Standard cognitive bias modification BEHAVIORAL

Participants will be asked to repeatedly listen to descriptions of ambiguous scenarios that resolve positively and answer one question following each scenario that reinforces the positive interpretation; participants will listen to 60 scenarios/day for 7 days.

Standard cognitive bias modification

Imagery enhanced cognitive bias modification BEHAVIORAL

Participants will be asked to imagine themselves as though they are actively involved in the scenarios that they listen to. This condition will be required to answer two questions following each scenario; one that reinforces the positive interpretation and another that promotes engagement with imagery. Participants will listen to 60 scenarios/day for 7 days.

Imagery enhanced cognitive bias modification

Neutral Control Condition BEHAVIORAL

Participants will be asked to listen to descriptions of neutral (i.e., non-emotional) scenarios. This condition will also be required to answer one comprehension question following each scenario. Participants will listen to 60 scenarios/day for 7 days.

Neutral Control Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score of 62 or higher on the Penn State Worry Questionnaire.
• Endorsement of symptoms of Generalized Anxiety Disorder (e.g., excessive and uncontrollable worry) as per the DSM-5 description (American Psychiatric Association, 2013).

You may not qualify if:

• Clinically significant suicidal ideation, intent, or plan
• Past or current history of psychosis, bipolar disorder, or substance or alcohol use disorder over the past 12 months
• Current psychological treatment or counseling unless this treatment is infrequent (once per month or less) or the participant has been receiving consistent weekly treatment for at least 12 weeks and still meets all other eligibility criteria
• Psychotropic medication with a change in dose in the past 12 weeks. If they have recently discontinued a psychotropic medication, they will be included if it has been at least 1 month since discontinuation, or 3 months if they had been taking fluoxetine. Use of benzodiazepines in the past 12 weeks will also exclude participants.
• Participants will be excluded if they report noncorrected hearing impairments as the training involves listening to audio recordings.
• Participants will be excluded if they do not have daily access to a computer with internet as this is required to complete the at home training.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Ministry of Research, Innovation and Science, Ontario: collaborator

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Links

• Lab Website

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: Baseline (pre-intervention) outcome measures will be completed at the first visit to our lab at Ryerson University. Participants will then be randomly assigned to one of the following conditions: (1) imagery CBM-I, (2) standard CBM-I (i.e., no instruction to use imagery), or (3) a neutral control condition. The participants will then practice their respective training at home for 7 days (60 scenarios/day). During this at-home training period, participants will track their worry three times per day. All the outcome measures will be reassessed at post-intervention, and 2-week follow-up. Worry will also be assessed at 1-week follow-up.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 26, 2019
• Study Start: August 20, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)