- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03420495
Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
March 16, 2020 updated by: Ryan Jane Jacoby, Massachusetts General Hospital
The investigators are examining whether conditions of ambiguity during decision-making may prime intolerance of uncertainty beliefs (i.e., difficulties coping with ambiguity, unpredictability, and the future) and lead to impaired performance when individuals with obsessive-compulsive disorder (OCD) are making uncertain decisions compared to non-psychiatric controls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary aims of this study are to examine the extent to which individuals with OCD avoid decisions that involve ambiguity through the use of self-report and behavioral measures.
Specifically, the investigators will examine how individuals with OCD minimize risk at the expense of monetary profit under conditions of ambiguity (relative to risky but unambiguous options) compared to non-psychiatric controls utilizing a series of judgment and decision-making (JDM) tasks.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults (age 18+)
- Meet DSM-5 criteria for principal OCD (OCD group) or no current DSM-5 diagnosis (NPC group).
- Sufficient fluency of English to understand study procedures and questionnaires
- Ability to provide informed consent.
- Comfortable and capable of using a computer to complete computer-based decision-making tasks.
Exclusion Criteria:
- Color-blindness (which prevents completion of certain tasks)
- Acute psychosis, bipolar disorder, substance use disorder, or suicidality. All other diagnostic comorbidities will be permitted to foster the accrual of a clinically relevant sample.
- Serious neurological disorder or impairment (e.g., brain damage, blindness), attention deficit hyperactivity disorder (ADHD), intellectual disability, or autism.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCD Group
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for principal OCD.
These participants will complete clinician interviews, self-report questionnaires, and receive the Decision-Making Tasks Intervention.
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All participants will receive a structured diagnostic assessment and complete self-report questionnaires about cognitive factors, decision-making styles, and anxiety/mood symptoms.
They then will be guided through three judgment and decision-making (JDM) paradigms (the Risk and Ambiguity Task, the Beads Task, and the Balloon Analogue Risk Task), each of which each has been modified to differ by whether the likelihood of potential adverse outcomes is provided (or whether it remains ambiguous).
|
Experimental: Non-psychiatric Control Group
No current DSM-5 diagnosis.
These participants will also complete clinician interviews, self-report questionnaires, and receive the Decision-Making Tasks Intervention.
|
All participants will receive a structured diagnostic assessment and complete self-report questionnaires about cognitive factors, decision-making styles, and anxiety/mood symptoms.
They then will be guided through three judgment and decision-making (JDM) paradigms (the Risk and Ambiguity Task, the Beads Task, and the Balloon Analogue Risk Task), each of which each has been modified to differ by whether the likelihood of potential adverse outcomes is provided (or whether it remains ambiguous).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ambiguity aversion score on the Risk and Ambiguity Task
Time Frame: Day 1
|
In the Risk and Ambiguity Task participants make repeated choices between a certain payoff vs. a gamble.
On low ambiguity trials, the likelihood of the gamble is known (i.e., "risky" lottery).
On high ambiguity trials, the likelihood of the gamble is unknown (i.e., "ambiguous" lottery).
Ambiguity aversion = (number of 50% risky lotteries chosen / total number of 50% risky lotteries) - (# of ambiguous lotteries chosen / total number of ambiguous lotteries).
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Day 1
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Average adjusted pump scores on the Balloon Analogue Risk Task (BART)
Time Frame: Day 1
|
In the BART participants blow up a series of virtual balloons.
With each pump: (a) they earn 5 cents that accumulate in a temporary reserve, but (b) the likelihood of the balloon exploding increases.
When this occurs participants lose the money in their temporary reserve.
At any time, participants can choose to transfer their earnings to a permanent savings bank (and move to the next balloon).
Thus, participants weigh the likelihood of the negative outcome (i.e., the balloon exploding and losing money) with the potential gains (i.e., 5 cents per pump).
In the low ambiguity version of the task, the likelihood of the balloon exploding is known.
In the high ambiguity version, the likelihood of the balloon exploding is unknown.
The average adjusted pump score = average number of pumps on trials in which the balloons did not explode.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Money spent on draws to decision (DTD) in the Beads Task
Time Frame: Day 1
|
The Beads Task is a probabilistic inference task in which participants gather as much information (i.e., beads) as they desire before feeling "certain" enough to decide from which jar the beads have come.
Participants will start off with a fixed amount of money, and invest money for each bead requested.
If they answer correctly, the money earned will be transferred to a savings bank; if incorrect, they lose any earnings from that trial.
Thus, participants must consider the tradeoff between the number of beads they choose and their accuracy as they decide.
In the low ambiguity version of the task, the ratio of colored beads inside the jar is known.
In the high ambiguity version, the ratio of colored beads inside the jar is unknown.
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Day 1
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Intolerance of Uncertainty Scale (IUS-12)
Time Frame: Day 1
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The IUS-12 measures reactions to uncertainty, ambiguity, and the future consisting of two subscales: Prospective and Inhibitory IU.
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2018
Primary Completion (Actual)
November 15, 2019
Study Completion (Actual)
November 15, 2019
Study Registration Dates
First Submitted
January 29, 2018
First Submitted That Met QC Criteria
January 29, 2018
First Posted (Actual)
February 5, 2018
Study Record Updates
Last Update Posted (Actual)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P002668
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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