Decision MakingNCT01799291
Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
A study testing Decision Making Tutorial in people with Decision Making and Bipolar Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Bipolar Disorder
- What is being tested?
- Decision Making Tutorial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants need to be: (a) licensed or currently supervised by a licensed mental health professional; and, (b) have experience treating child and adolescent patient populations for mental health issues.
Who cannot join
- Not meeting criterion (a) or (b) above.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Decision Making and Mental Health: Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them in recommended de-biasing strategies. The investigators hypothesize that the Treatment group will show higher diagnostic accuracy than the Control condition: Participants receiving the cognitive de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity bias. Secondary aims include soliciting feedback about whether the skills were useful when diagnosing the vignettes, and whether skills and cases seem clinically realistic.
Read the detailed description
A randomized controlled trial (RCT) of 100 participants will test the efficacy of a new intervention to improve clinical judgment.
Eligible participants will be licensed or currently supervised by a licensed mental health professional and have experience working with pediatric populations.
Participants will be randomly assigned to either Treatment or Control conditions. All participants receive a 5 minute pre-recorded presentation about mood disorders, then read several case vignettes and respond to questions regarding judgments about probable diagnoses and next clinical actions.
Study administration is Web-based via a secure portal. After answering questions to confirm eligibility and provide informed consent, participants will complete a background questionnaire. The Web software, Qualtrics, will randomize participants to watch a brief presentation on mood disorders (i.e., Control condition) versus the same presentation on mood disorders combined with the intervention (i.e., Treatment condition). The intervention is a 20-minute training on decision-making errors and cognitive de-biasing strategies.
Next, all participants review four clinical vignettes. Using only four vignettes reduces participant burden and maximizes response rate. Qualtrics presents the case vignettes in random orders.
After completing the last vignette and corresponding questions, participants in the treatment condition rate their experience of the intervention. These questions address the secondary study aims: (a) how participants will use these new techniques in their clinical practice; and, (b) how the investigators can tailor the intervention to make it even more user-friendly and appealing to clinical audiences.
- Conditions
- Decision Making, Bipolar Disorder
- Being tested
- Decision Making Tutorial
- Keywords
- Decision Making, Pediatric Bipolar Disorder, Assessment, Intervention
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Making TutorialBehavioural
A web-based presentation focused on key "cognitive de-biasing" strategies, including helping clinician participants: consider alternative diagnoses (e.g., symptom checklists); decrease reliance on memory (e.g., mnemonics); and incorporate Bayesian reasoning (e.g., actuarial approaches).
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Decision Making Tutorial | Other | A brief presentation on mood disorders (i.e., Control condition) combined with the intervention (i.e., Treatment condition): a 20-minute training on decision-making errors and cognitive de-biasing strategies. Receives: Behavioral: Decision Making Tutorial |
| Control | No intervention | A brief presentation about mood disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Participants in treatment and control conditions report vignette characters' probable diagnoses after reading each vignette. These diagnoses were rated on a 3-point Likert scale of (1 = inaccurate diagnosis, 2 = somewhat accurate, and 3 = accurate diagnosis) using criteria established by the research team (which includes expert diagnosticians).
Measured: one time, immediately following Web-based presentation(s)
Secondary outcomes (1)
Clinician attitudes toward intervention
Participants in the treatment group complete a brief questionnaire (4 items) about their attitudes toward the cognitive de-biasing intervention. This measure describes different aspects of the intervention (e.g., how helpful it was in making diagnostic decisions), and requires participants to make ratings on a 6-point scale: (1) strong agree; (2) agree; (3) somewhat agree; (4) somewhat disagree; (5) disagree; and, (6) strong disagree.
Measured: one time, immediately after Web-based intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Melissa M Jenkins, M.A., Principal investigator, University of North Carolina, Chapel HillEric A Youngstrom, Ph.D., Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799291
- Sponsor's protocol ID
- 2KR401204-MMJ
- Status last verified
- Sep 2013
- First submitted
- 24 Feb 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making and Mental Health: Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01799291
- Acronym / sponsor ID
- 2KR401204-MMJ
- Conditions
- Decision Making, Bipolar Disorder
- Keywords
- Decision Making, Pediatric Bipolar Disorder, Assessment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- 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.
The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them in recommended de-biasing strategies. The investigators hypothesize that the Treatment group will show higher diagnostic accuracy than the Control condition: Participants receiving the cognitive de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity bias. Secondary aims include soliciting feedback about whether the skills were useful when diagnosing the vignettes, and whether skills and cases seem clinically realistic.
Detailed description
A randomized controlled trial (RCT) of 100 participants will test the efficacy of a new intervention to improve clinical judgment.
Eligible participants will be licensed or currently supervised by a licensed mental health professional and have experience working with pediatric populations.
Participants will be randomly assigned to either Treatment or Control conditions. All participants receive a 5 minute pre-recorded presentation about mood disorders, then read several case vignettes and respond to questions regarding judgments about probable diagnoses and next clinical actions.
Study administration is Web-based via a secure portal. After answering questions to confirm eligibility and provide informed consent, participants will complete a background questionnaire. The Web software, Qualtrics, will randomize participants to watch a brief presentation on mood disorders (i.e., Control condition) versus the same presentation on mood disorders combined with the intervention (i.e., Treatment condition). The intervention is a 20-minute training on decision-making errors and cognitive de-biasing strategies.
Next, all participants review four clinical vignettes. Using only four vignettes reduces participant burden and maximizes response rate. Qualtrics presents the case vignettes in random orders.
After completing the last vignette and corresponding questions, participants in the treatment condition rate their experience of the intervention. These questions address the secondary study aims: (a) how participants will use these new techniques in their clinical practice; and, (b) how the investigators can tailor the intervention to make it even more user-friendly and appealing to clinical audiences.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: Decision Making Tutorial | Other | Behavioral: Decision Making TutorialA brief presentation on mood disorders (i.e., Control condition) combined with the intervention (i.e., Treatment condition): a 20-minute training on decision-making errors and cognitive de-biasing strategies. |
| Control | No intervention | –A brief presentation about mood disorders. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants need to be: (a) licensed or currently supervised by a licensed mental health professional; and, (b) have experience treating child and adolescent patient populations for mental health issues.
Key exclusion criteria (1 listed)
- Not meeting criterion (a) or (b) above.
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 |
|---|---|---|
| Decision Making TutorialA web-based presentation focused on key "cognitive de-biasing" strategies, including helping clinician participants: consider alternative diagnoses (e.g., symptom checklists); decrease reliance on memory (e.g., mnemonics); and incorporate Bayesian reasoning (e.g., actuarial approaches). | Behavioural | Treatment: Decision Making Tutorial |
Primary outcome
Diagnostic accuracy
Time frame: one time, immediately following Web-based presentation(s)
Participants in treatment and control conditions report vignette characters' probable diagnoses after reading each vignette. These diagnoses were rated on a 3-point Likert scale of (1 = inaccurate diagnosis, 2 = somewhat accurate, and 3 = accurate diagnosis) using criteria established by the research team (which includes expert diagnosticians).
1 secondary outcome
Clinician attitudes toward intervention
Time frame: one time, immediately after Web-based intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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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.
Melissa M Jenkins, M.A. principal investigator
University of North Carolina, Chapel Hill
Eric A Youngstrom, Ph.D. study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Making Tutorial in people with Decision Making and Bipolar Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Apr 2017. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy (time frame: one time, immediately following Web-based presentation(s)). 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 25 Apr 2017.