Excessive WorryNCT03855488
Imagery Enhanced Cognitive Bias Modification for Chronic Worry
A study testing Standard cognitive bias modification and Imagery enhanced cognitive bias modification in people with Excessive Worry, run by Toronto Metropolitan University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excessive Worry
- What is being tested?
- Standard cognitive bias modification and Imagery enhanced cognitive bias modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2019to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Excessive Worry
- Being tested
- Standard cognitive bias modification, Imagery enhanced cognitive bias modification, Neutral Control Condition
- Keywords
- Worry, Anxiety, Imagery, Cognitive bias modification
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cognitive bias modificationBehavioural
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 modificationBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard cognitive bias modification | Experimental | Listen to descriptions of ambiguous scenarios that resolve positively Receives: Behavioral: Standard cognitive bias modification |
| Imagery enhanced cognitive bias modification | Experimental | Listen to descriptions of ambiguous scenarios that resolve positively while engaging in imagery Receives: Behavioral: Imagery enhanced cognitive bias modification |
| Neutral Control Condition | Placebo comparator | Listen to descriptions of neutral scenarios Receives: Behavioral: Neutral Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Self-report measure that assesses depression, anxiety and stress symptoms over the past week. The scale contains 21 items, divided into three subscales: 1) Depression, 2) Anxiety, and 3) Stress. Scores on the subscales range from 0 to 42, with higher scores indicating greater severity of depression, anxiety and stress.
Measured: 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
Self-report measure of one's ability to conceptualize step-by-step strategies to solve two real-life problems. Problem solutions will be assessed for concreteness and effectiveness using a coding scheme.
Measured: 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
Self-report measure of the vividness and arousal associated with prospective positive and negative events, as well as the estimated likelihood that the prospective event might happen to them in the future. The scale contains 10 prospective positive events and 10 prospective negative events and ratings of vividness, arousal, and likelihood are made on a scale from 1 - 5, with higher scores indicating greater vividness, arousal, and likelihood.
Measured: 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
A computerized measure of interpretation bias. Participants are presented with an ambiguous sentence followed by a word that gives the sentence either a benign or threatening meaning. Participants are required to choose as quickly as possible whether the word is related to the ambiguous sentence (i.e., accept or reject). A greater tendency to 'accept' threatening interpretations and 'reject' benign interpretations would suggest a greater negative interpretation bias.
Measured: 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
A behavioral measure of negative thought intrusions that involves a 5-minute breathing period, followed by a 5-minute period of instructed worry and then a second 5-minute breathing period. During the breathing periods, a tone sounds every 30 seconds and participants are instructed to report on whether they were focused on their breathing or if they had a thought intrusion. The thought intrusions are rated on their valence and the content of the intrusions is elaborated on further at the end of the task.
Measured: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
Daily Worry Questions
A daily self-report measure of worry controllability, worry intensity, and distress associated with worry (all rated on a scale from 0 - 8) as well as time spent worrying (rated as a percentage).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start20 Aug 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Why it stopped: No in-person testing is permitted at Ryerson University due to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive WorryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Research, Innovation and Science, Ontario
- Responsible party
- Principal investigator, Bailee Malivoire, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855488
- Sponsor's protocol ID
- REB 2018-394
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2019
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, anonymized aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing anonymized data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery Enhanced Cognitive Bias Modification for Chronic Worry
- ClinicalTrials.gov ID
- NCT03855488
- Acronym / sponsor ID
- REB 2018-394
- Conditions
- Excessive Worry
- Keywords
- Worry, Anxiety, Imagery, Cognitive bias modification
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: No in-person testing is permitted at Ryerson University due to COVID-19.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Ministry of Research, Innovation and Science, Ontario
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard cognitive bias modification | Experimental | Behavioral: Standard cognitive bias modificationListen to descriptions of ambiguous scenarios that resolve positively |
| Imagery enhanced cognitive bias modification | Experimental | Behavioral: Imagery enhanced cognitive bias modificationListen to descriptions of ambiguous scenarios that resolve positively while engaging in imagery |
| Neutral Control Condition | Placebo comparator | Behavioral: Neutral Control ConditionListen to descriptions of neutral scenarios |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard cognitive bias modificationParticipants 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. | Behavioural | Standard cognitive bias modification |
| Imagery enhanced cognitive bias modificationParticipants 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. | Behavioural | Imagery enhanced cognitive bias modification |
| Neutral Control ConditionParticipants 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. | Behavioural | Neutral Control Condition |
Primary outcome
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
Time frame: 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.
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.
Change in self-reported interpretation bias as measured by Ambiguous/ Unambiguous Situations Diary Extended
Time frame: 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-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.
6 secondary outcomes
Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Administered on day 1 prior to completing the intervention (pre-intervention), following the intervention week (post-intervention), and at a 2-week follow-up.
Daily Worry Questions
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, anonymized aggregate participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing anonymized data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal. No individual data will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard cognitive bias modification and Imagery enhanced cognitive bias modification in people with Excessive Worry, run by Toronto Metropolitan University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.