Back to resultsDecision-making Impairments in OCD: An Integrated Behavioral Economics Model
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision-Making Tasks
Sponsored by
About this trial
This is an interventional diagnostic trial for Obsessive-Compulsive Disorder focused on measuring OCD, Intolerance of Uncertainty
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
OCD Group
Non-psychiatric Control Group
Arm Description
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.
No current DSM-5 diagnosis. These participants will also complete clinician interviews, self-report questionnaires, and receive the Decision-Making Tasks Intervention.
Outcomes
Primary Outcome Measures
Ambiguity aversion score on the Risk and Ambiguity Task
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).
Average adjusted pump scores on the Balloon Analogue Risk Task (BART)
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.
Secondary Outcome Measures
Money spent on draws to decision (DTD) in the Beads Task
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.
Intolerance of Uncertainty Scale (IUS-12)
The IUS-12 measures reactions to uncertainty, ambiguity, and the future consisting of two subscales: Prospective and Inhibitory IU.
Full Information
NCT ID
NCT03420495
First Posted
January 29, 2018
Last Updated
March 16, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Obsessive Compulsive Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03420495
Brief Title
Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
Official Title
Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Obsessive Compulsive Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, Intolerance of Uncertainty
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The current study has two diagnostic arms (the OCD group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCD Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-psychiatric Control Group
Arm Type
Experimental
Arm Description
No current DSM-5 diagnosis. These participants will also complete clinician interviews, self-report questionnaires, and receive the Decision-Making Tasks Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Decision-Making Tasks
Intervention Description
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).
Primary Outcome Measure Information:
Title
Ambiguity aversion score on the Risk and Ambiguity Task
Description
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).
Time Frame
Day 1
Title
Average adjusted pump scores on the Balloon Analogue Risk Task (BART)
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Money spent on draws to decision (DTD) in the Beads Task
Description
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.
Time Frame
Day 1
Title
Intolerance of Uncertainty Scale (IUS-12)
Description
The IUS-12 measures reactions to uncertainty, ambiguity, and the future consisting of two subscales: Prospective and Inhibitory IU.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan J Jacoby, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
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