Back to resultsThe Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"
Primary Purpose
Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Control Tasks and Script Driven Imagery
Sponsored by
About this trial
This is an interventional diagnostic trial for Obsessive-Compulsive Disorder focused on measuring OCD, GAD, MDD, Rumination, Obsession, Worry
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intrusive Thoughts Group
Non-psychiatric Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
Secondary Outcome Measures
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").
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.
Full Information
NCT ID
NCT03414619
First Posted
January 23, 2018
Last Updated
March 16, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Health Resources in Action, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03414619
Brief Title
The Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"
Official Title
The Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Health Resources in Action, Inc.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Major Depressive Disorder
Keywords
OCD, GAD, MDD, Rumination, Obsession, Worry
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 Intrusive Thoughts group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrusive Thoughts Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-psychiatric Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Control Tasks and Script Driven Imagery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Commission Errors on the Go/No Go Task
Description
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).
Time Frame
Day 1
Title
Response time on the Stroop Color Word Test
Description
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.
Time Frame
Day 1
Title
Perseverative Errors on the Wisconsin Card Sort Test
Description
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.
Time Frame
Day 1
Title
Gaze latency on the Attentional Engagement-Disengagement Task
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Perseverative Thinking Questionnaire (PTQ)
Description
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").
Time Frame
Day 1
Title
State measure of intrusive thinking
Description
Participants will be asked questions on a visual analog scale from 0 "not at all" to 100 "extremely" regarding state experiences of intrusive thoughts.
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+)
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.
Exclusion Criteria:
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.
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
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The Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"
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