Obsessive-Compulsive DisorderNCT03420495
Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
A study testing Decision-Making Tasks in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Decision-Making Tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 15 Nov 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Decision-Making Tasks
- Keywords
- OCD, Intolerance of Uncertainty
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-Making TasksBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| OCD Group | Experimental | 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. Receives: Behavioral: Decision-Making Tasks |
| Non-psychiatric Control Group | Experimental | No current DSM-5 diagnosis. These participants will also complete clinician interviews, self-report questionnaires, and receive the Decision-Making Tasks Intervention. Receives: Behavioral: Decision-Making Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start3 May 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Obsessive Compulsive Foundation
- Responsible party
- Principal investigator, Ryan Jane Jacoby, Massachusetts General Hospital
- Investigators
- Ryan J Jacoby, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420495
- Sponsor's protocol ID
- 2017P002668
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
- ClinicalTrials.gov ID
- NCT03420495
- Acronym / sponsor ID
- 2017P002668
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, Intolerance of Uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Obsessive Compulsive Foundation
- Study start
- 3 May 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 5 Feb 2018 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The current study has two diagnostic arms (the OCD group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
| Arm | Type | Receives |
|---|---|---|
| OCD Group | Experimental | Behavioral: Decision-Making TasksMeet 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. |
| Non-psychiatric Control Group | Experimental | Behavioral: Decision-Making TasksNo current DSM-5 diagnosis. These participants will also complete clinician interviews, self-report questionnaires, and receive the Decision-Making Tasks Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 TasksAll 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). | Behavioural | Non-psychiatric Control Group, OCD Group |
Primary outcome
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).
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.
2 secondary outcomes
Money spent on draws to decision (DTD) in the Beads Task
Time frame: Day 1
Intolerance of Uncertainty Scale (IUS-12)
Time frame: Day 1
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 18 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Ryan J Jacoby, Ph.D. principal investigator
Massachusetts General Hospital
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 Tasks in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital 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 5 inclusion and 3 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 18 Mar 2020. 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?
Ambiguity aversion score on the Risk and Ambiguity Task (time frame: Day 1). 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 18 Mar 2020.