NCT03414619

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 18, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

January 23, 2018

Last Update Submit

March 16, 2020

Conditions

Keywords

OCDGADMDDRuminationObsessionWorry

Outcome Measures

Primary Outcomes (4)

  • 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).

    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.

    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.

    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.

    Day 1

Secondary Outcomes (2)

  • Perseverative Thinking Questionnaire (PTQ)

    Day 1

  • State measure of intrusive thinking

    Day 1

Study Arms (2)

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.

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.

Behavioral: Cognitive Control Tasks and Script Driven Imagery

Interventions

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.

Intrusive Thoughts GroupNon-psychiatric Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obsessive-Compulsive DisorderGeneralized Anxiety DisorderDepressive Disorder, MajorRumination SyndromeObsessive Behavior

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersDepressive DisorderMood DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersBehavioral SymptomsBehavior

Study Officials

  • Ryan J Jacoby, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The current study has two diagnostic arms (the Intrusive Thoughts group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ryan Jane Jacoby, Ph.D., Clinical Psychologist, OCD and Related Disorders Program

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

May 18, 2018

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations