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Trial record 2 of 17 for:    sabine wilhelm

Decision-making Impairments in OCD: An Integrated Behavioral Economics Model

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ClinicalTrials.gov Identifier: NCT03420495
Recruitment Status : Not yet recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
Obsessive Compulsive Foundation
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Obsessive-Compulsive Disorder Behavioral: Decision-Making Tasks

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. The investigators will also explore two different strategic responses to ambiguity: information gathering and escape/avoidance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
Anticipated Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Behavioral: Decision-Making Tasks
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.
Behavioral: Decision-Making Tasks
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 Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Intolerance of Uncertainty Scale (IUS-12) [ Time Frame: Day 1 ]
    The IUS-12 measures reactions to uncertainty, ambiguity, and the future consisting of two subscales: Prospective and Inhibitory IU.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420495


Contacts
Contact: Ryan J Jacoby, Ph.D. 617-724-4167 rjjacoby@mgh.harvard.edu
Contact: Jin Shin, B.A. 617-724-4354 jshin15@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan J Jacoby, Ph.D.    617-724-4167    rjjacoby@mgh.harvard.edu   
Contact: Jin Shin, B.A.    617-724-4354    jshin15@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Obsessive Compulsive Foundation
Investigators
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital

Responsible Party: Sabine Wilhelm, Sabine Wilhelm, Ph.D., Chief of Psychology, Director of OCD and Related Disorders Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03420495     History of Changes
Other Study ID Numbers: 2017P002668
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sabine Wilhelm, Massachusetts General Hospital:
OCD
Intolerance of Uncertainty

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders