Obsessive-Compulsive DisorderNCT03414619
The Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"
A study of Obsessive-Compulsive Disorder and Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are examining whether difficulties with cognitive control (i.e., the ability to stop one's thought process and shift attention) is a common problem across three types of repetitive, negative thinking: obsessions (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety… 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, Generalized Anxiety Disorder, Major Depressive Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2018to 6 Mar 2020
- 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+)
- Intrusive thoughts group: Clinically significant intrusive thought in the domain of obsessions, worries, or depressive ruminations with a score above the clinical mean (≥ 37) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ)
- Non-psychiatric control (NPC) group: A score 1 SD below the community mean (≤ 15) on the trait repetitive negative thinking measure (PTQ)
- Sufficient fluency of English to understand study procedures and questionnaires
- Ability to provide informed consent.
- Comfortable and capable of using a computer and completing reaction-time tasks.
Who cannot join
- Acute psychosis, mania, or suicidality
- Diagnosis of post-traumatic stress disorder (PTSD; in order to preserve diagnostic clarity of the domains of intrusive thoughts under investigation)
- 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 difficulties with cognitive control (i.e., the ability to stop one's thought process and shift attention) is a common problem across three types of repetitive, negative thinking: obsessions (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in major depressive disorder, MDD).
Read the detailed description
The primary aims of this study are to utilize self-report and behavioral measures to examine whether cognitive control is a common factor across three types of repetitive negative thinking (RNT): obsessions in OCD, worries in GAD, and ruminations in MDD. Specifically, the investigators aim to test whether individuals with obsessions, worries, and depressive ruminations demonstrate impaired cognitive control on executive functioning neuropsychological tasks (i.e., response inhibition, set shifting, attentional disengagement) relative to individuals without any psychiatric diagnoses. Additionally, the investigators will examine whether these deficits are associated with self-report measures of RNT as well as in vivo responding during a laboratory paradigm designed to induce intrusive thinking. Findings could inform psychological treatment of these problematic intrusions using novel transdiagnostic approaches.
- Being tested
- Cognitive Control Tasks and Script Driven Imagery
- Keywords
- OCD, GAD, MDD, Rumination, Obsession, Worry
- Medical subject headings
- Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Depressive Disorder, Major, Rumination Syndrome, Obsessive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Control Tasks and Script Driven ImageryBehavioural
All participants will receive a structured diagnostic assessment and complete self-report questionnaires about cognitive factors and anxiety/mood symptoms. They then will complete a battery of neuropsychological executive functioning tasks on the computer, each of which measures a different facet of cognitive control (i.e., response inhibition, cognitive flexibility, and attentional control). Finally, they will be guided through a standardized script-driven imagery paradigm that involves generating and listening to an individualized imaginal script associated with a moderately distressing intrusive thought. Self-report and psychophysiological data will be collected during this exercise.
| Study group | Role | What they receive |
|---|---|---|
| Intrusive Thoughts Group | Experimental | Clinically significant intrusive thought in the domain of obsessions, worries, or depressive ruminations with a score above the clinical mean (≥ 37) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ). These participants will receive the Cognitive Control Tasks and Script Driven Imagery Intervention. Receives: Behavioral: Cognitive Control Tasks and Script Driven Imagery |
| Non-psychiatric Control Group | Experimental | A score 1 SD below the community mean (≤ 15) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ). These participants will also receive the Cognitive Control Tasks and Script Driven Imagery Intervention. Receives: Behavioral: Cognitive Control Tasks and Script Driven Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Commission Errors on the Go/No Go Task
In the Go/No Go Task participants press a button immediately upon detecting a target stimulus (e.g., a square), but are told to refrain from responding to a "no go" stimulus (e.g., a cross of similar size). The main outcome is commission errors (i.e., responding to a "no go" stimulus).
Measured: Day 1
Response time on the Stroop Color Word Test
In the Stroop Color Word Test participants are asked to name the color of the ink in which words are printed, rather than reading the words.
Measured: Day 1
Perseverative Errors on the Wisconsin Card Sort Test
In the Wisconsin Card Sort Test participants are asked to match a stack of response cards to four stimulus cards without knowing the matching rule. They receive feedback for each trial about whether their matching was correct or not. After ten consecutive correct trials, the matching criterion changes without notice requiring the use of flexible goal-driven strategies.
Measured: Day 1
Gaze latency on the Attentional Engagement-Disengagement Task
In the Attentional Engagement-Disengagement Task two emotional facial stimuli are presented on the computer screen (i.e., happy, disgusted, fearful, and sad faces paired with neutral faces) and eye tracking (when participants shift from the emotional to neutral face and vice versa) is measured.
Measured: Day 1
Secondary outcomes (2)
Perseverative Thinking Questionnaire (PTQ)
The Perseverative Thinking Questionnaire is a 15-item measure of repetitive, negative thinking considered independent of disorder-specific content (e.g., "The same thoughts keep going through my mind again and again").
Measured: Day 1
State measure of intrusive thinking
Participants will be asked questions on a visual analog scale from 0 "not at all" to 100 "extremely" regarding state experiences of intrusive thoughts.
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 posted30 Jan 2018
- Study start18 May 2018
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 Intrusive Thoughts group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources in Action, Inc.
- 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
- NCT03414619
- Sponsor's protocol ID
- 2017P002114
- Status last verified
- Mar 2020
- First submitted
- 23 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
Publications
Daniel KE, Wilhelm S, Jacoby RJ. Predictors of polyregulation and its effectiveness following exposure to One's most personally distressing intrusive thought. J Behav Ther Exp Psychiatry. 2025 Mar;86:102001. doi: 10.1016/j.jbtep.2024.102001. Epub 2024 Dec 1.
PubMed 39626971
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
- The Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"
- ClinicalTrials.gov ID
- NCT03414619
- Acronym / sponsor ID
- 2017P002114
- Keywords
- OCD, GAD, MDD, Rumination, Obsession, Worry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Health Resources in Action, Inc.
- Study start
- 18 May 2018 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 30 Jan 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 difficulties with cognitive control (i.e., the ability to stop one's thought process and shift attention) is a common problem across three types of repetitive, negative thinking: obsessions (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in major depressive disorder, MDD).
Detailed description
The primary aims of this study are to utilize self-report and behavioral measures to examine whether cognitive control is a common factor across three types of repetitive negative thinking (RNT): obsessions in OCD, worries in GAD, and ruminations in MDD. Specifically, the investigators aim to test whether individuals with obsessions, worries, and depressive ruminations demonstrate impaired cognitive control on executive functioning neuropsychological tasks (i.e., response inhibition, set shifting, attentional disengagement) relative to individuals without any psychiatric diagnoses. Additionally, the investigators will examine whether these deficits are associated with self-report measures of RNT as well as in vivo responding during a laboratory paradigm designed to induce intrusive thinking. Findings could inform psychological treatment of these problematic intrusions using novel transdiagnostic approaches.
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 Intrusive Thoughts group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
| Arm | Type | Receives |
|---|---|---|
| Intrusive Thoughts Group | Experimental | Behavioral: Cognitive Control Tasks and Script Driven ImageryClinically significant intrusive thought in the domain of obsessions, worries, or depressive ruminations with a score above the clinical mean (≥ 37) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ). These participants will receive the Cognitive Control Tasks and Script Driven Imagery Intervention. |
| Non-psychiatric Control Group | Experimental | Behavioral: Cognitive Control Tasks and Script Driven ImageryA score 1 SD below the community mean (≤ 15) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ). These participants will also receive the Cognitive Control Tasks and Script Driven Imagery Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (age 18+)
- Intrusive thoughts group: Clinically significant intrusive thought in the domain of obsessions, worries, or depressive ruminations with a score above the clinical mean (≥ 37) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ)
- Non-psychiatric control (NPC) group: A score 1 SD below the community mean (≤ 15) on the trait repetitive negative thinking measure (PTQ)
- Sufficient fluency of English to understand study procedures and questionnaires
- Ability to provide informed consent.
Key exclusion criteria (3 listed)
- Acute psychosis, mania, or suicidality
- Diagnosis of post-traumatic stress disorder (PTSD; in order to preserve diagnostic clarity of the domains of intrusive thoughts under investigation)
- 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 |
|---|---|---|
| Cognitive Control Tasks and Script Driven ImageryAll participants will receive a structured diagnostic assessment and complete self-report questionnaires about cognitive factors and anxiety/mood symptoms. They then will complete a battery of neuropsychological executive functioning tasks on the computer, each of which measures a different facet of cognitive control (i.e., response inhibition, cognitive flexibility, and attentional control). Finally, they will be guided through a standardized script-driven imagery paradigm that involves generating and listening to an individualized imaginal script associated with a moderately distressing intrusive thought. Self-report and psychophysiological data will be collected during this exercise. | Behavioural | Intrusive Thoughts Group, Non-psychiatric Control Group |
Primary outcome
Commission Errors on the Go/No Go Task
Time frame: Day 1
In the Go/No Go Task participants press a button immediately upon detecting a target stimulus (e.g., a square), but are told to refrain from responding to a "no go" stimulus (e.g., a cross of similar size). The main outcome is commission errors (i.e., responding to a "no go" stimulus).
Response time on the Stroop Color Word Test
Time frame: Day 1
In the Stroop Color Word Test participants are asked to name the color of the ink in which words are printed, rather than reading the words.
Perseverative Errors on the Wisconsin Card Sort Test
Time frame: Day 1
In the Wisconsin Card Sort Test participants are asked to match a stack of response cards to four stimulus cards without knowing the matching rule. They receive feedback for each trial about whether their matching was correct or not. After ten consecutive correct trials, the matching criterion changes without notice requiring the use of flexible goal-driven strategies.
Gaze latency on the Attentional Engagement-Disengagement Task
Time frame: Day 1
In the Attentional Engagement-Disengagement Task two emotional facial stimuli are presented on the computer screen (i.e., happy, disgusted, fearful, and sad faces paired with neutral faces) and eye tracking (when participants shift from the emotional to neutral face and vice versa) is measured.
2 secondary outcomes
Perseverative Thinking Questionnaire (PTQ)
Time frame: Day 1
State measure of intrusive thinking
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.
- Derived from this study: PubMed 39626971Daniel KE, Wilhelm S, Jacoby RJ. Predictors of polyregulation and its effectiveness following exposure to One's most personally distressing intrusive thought. J Behav Ther Exp Psychiatry. 2025 Mar;86:102001. doi: 10.1016/j.jbtep.2024.102001. Epub 2024 Dec 1.
- 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 of Obsessive-Compulsive Disorder and Generalized Anxiety 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 6 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?
Commission Errors on the Go/No Go Task (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03414619, which also lists 1 linked publication.
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.