Imagery Enhanced Cognitive Bias Modification for Chronic Worry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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In pathological worry, 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 is suggested to fuel worry. This type of "mental habit" can maintain worry and cause people a lot of distress. Cognitive bias modification of interpretations (CBM-I) involves repeatedly and actively listening to descriptions of ambiguous scenarios that resolve in a benign fashion. CBM-I has shown promise at reducing the tendency to make negative interpretations when presented with ambiguous information as well as improving worry and low mood. However, further research is needed to optimize the protocol for individuals who engage in pathological worry. One such way to improve the task is using imagery. In this proof-of-concept experiment, the investigators are looking at whether having participants use imagery while practicing CBM-I for one week leads to greater improvements in worry and worry-related processes compared to the standard protocol without imagery instructions and compared to a neutral control condition. This study will also investigate dosage effects of CBM-I training by investigating changes in worry over the intervention period using a daily diary assessment.

Potential participants will be asked to complete a telephone screen. Those who meet eligibility criteria will be invited to our laboratory at Ryerson University. After completing pre-intervention outcome measures, participants will be randomly assigned to one of three conditions: (1) a condition where people imagine themselves in scenarios they listen to; (2) a condition where people listen to the scenarios without instruction to use imagery; and (3) a condition in which people listen to passages of non-emotional situations. Participants will be asked to complete their respective training for 7 days (60 scenarios/day). There will be two follow-up visits; one after participants complete their training and another two weeks following completion of the training. All of the outcome measures will be assessed pre-intervention, post-intervention and at the 2-week follow-up. Past week worry will also be assessed at a 1-week follow-up via a link that will be emailed. During the 1-week intervention period participants will also track their worry 3 times per day via a link that will be emailed to them.

The present experiment will provide answers to important questions about the therapeutic potential of imagery enhanced CBM compared to standard CBM for pathological worry. Moreover, this study will shed light on dosing effects of the intervention.

Conditions

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Excessive Worry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard cognitive bias modification

Listen to descriptions of ambiguous scenarios that resolve positively

Group Type EXPERIMENTAL

Standard cognitive bias modification

Intervention Type 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.

Imagery enhanced cognitive bias modification

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

Group Type EXPERIMENTAL

Imagery enhanced cognitive bias modification

Intervention Type 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.

Neutral Control Condition

Listen to descriptions of neutral scenarios

Group Type PLACEBO_COMPARATOR

Neutral Control Condition

Intervention Type 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.

Interventions

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Standard cognitive bias modification

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.

Intervention Type BEHAVIORAL

Imagery enhanced cognitive bias modification

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.

Intervention Type BEHAVIORAL

Neutral Control Condition

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Clinically significant suicidal ideation, intent, or plan
2. Past or current history of psychosis, bipolar disorder, or substance or alcohol use disorder over the past 12 months
3. 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
4. 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.
5. Participants will be excluded if they report noncorrected hearing impairments as the training involves listening to audio recordings.
6. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No