Clinical trial NCT03855488: Imagery Enhanced Cognitive Bias Modification for Chronic Worry
Official title: Imagery Enhanced Cognitive Bias Modification for Chronic Worry
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Excessive Worry
Keywords: Worry
Anxiety
Imagery
Cognitive bias modification
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Ministry of Research, Innovation and Science, Ontario
First posted: 2019-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
timeFrame: 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.
measure: Change in self-reported interpretation bias as measured by Ambiguous/ Unambiguous Situations Diary Extended
timeFrame: 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:
measure: Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale.
timeFrame: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
measure: Quality of problem solving as measured by the Means-Ends Problem-Solving task
timeFrame: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
measure: Self-reported vividness, arousal, and likelihood of positive and negative prospective scenarios as measured by the Prospective Imagery Task
timeFrame: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
measure: Interpretation bias as measured by the Word-Sentence Association Paradigm
timeFrame: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
measure: Self-reported negative thought intrusions as measured by the Breathing Focus Task
timeFrame: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
measure: Daily Worry Questions
timeFrame: During the 7-day intervention period, all participants are asked to respond to questions about their worry three times per day (morning, afternoon, evening) using an online diary.
Other outcomes:
measure: Self reported belief that the training will improve worry as measured by the Credibility Expectancy Check (CEQ)
timeFrame: Administered on day 1 prior to completing the intervention (pre-intervention) following the explanation of the intervention and the rationale.
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
References: