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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03414619
Other study ID # 2017P002114
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 18, 2018
Est. completion date March 6, 2020

Study information

Verified date March 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 disorder, GAD), and ruminations (as seen in major depressive disorder, MDD).


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date March 6, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Adults (age 18+)

2. 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)

3. Non-psychiatric control (NPC) group: A score 1 SD below the community mean (= 15) on the trait repetitive negative thinking measure (PTQ)

4. Sufficient fluency of English to understand study procedures and questionnaires

5. Ability to provide informed consent.

6. Comfortable and capable of using a computer and completing reaction-time tasks.

Exclusion Criteria:

1. Acute psychosis, mania, or suicidality

2. Diagnosis of post-traumatic stress disorder (PTSD; in order to preserve diagnostic clarity of the domains of intrusive thoughts under investigation)

3. Serious neurological disorder or impairment (e.g., brain damage, blindness), attention deficit hyperactivity disorder (ADHD), intellectual disability, or autism.

Study Design


Intervention

Behavioral:
Cognitive Control Tasks and Script Driven Imagery
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Health Resources in Action, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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"). Day 1
Secondary 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. Day 1
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