Improving Attentional and Cognitive Control in the Psychological Treatment of Intrusive Thoughts

NCT ID: NCT04225624

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2025-04-09

Brief Summary

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The investigators are conducting this study to learn more about the cognitive and attentional processes among individuals with three types of repetitive negative thinking (RNT): mental rituals (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in major depressive disorder, MDD). Specifically, the investigators are studying whether psychological treatment can help people with RNT who have trouble stopping unwanted thoughts and shifting their attention.

Detailed Description

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The current study will examine whether enhancing attention regulation skills in a transdiagnostic intervention for repetitive negative thinking (RNT) will significantly improve the target of attentional/cognitive control. Participants will be randomly assigned (like the flip of a coin) to receive eight 60 minute sessions (over 8 weeks) of either: Emotion Regulation Therapy-Attention Regulation (AR-ERT) or Supportive Psychotherapy (SPT). The investigators will use a multi-method approach to measure attentional/cognitive control: (a) behavioral (i.e., eye tracking fixations and reaction time), (b) electrophysiological (i.e., event related potentials), and (c) self-report (i.e., perceived ability to shift and focus attention). They also will examine early signs of treatment efficacy of AR-ERT and SPT and target validation (i.e., whether changes in attentional/cognitive control correlate with changes in RNT and associated symptoms). Participants will receive assessments of these target and outcome measures at baseline (week 0), mid-treatment (week 4), post-treatment (week 8), and 3-month follow-up (week 20). While most of these procedures are conducted virtually (e.g., therapy sessions), some (e.g., eye tracking and electrophysiological assessments) will be performed in-person. Findings could help identify a cross-cutting target that can be engaged to optimize treatment response for individuals with elevated RNT.

Conditions

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Obsessive-Compulsive Disorder Generalized Anxiety Disorder Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At the baseline visit, eligible participants will be randomized (1:1 in parallel) to AR-ERT or SPT.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Independent evaluators will remain blind to treatment condition throughout the study for all participants. Participants and study therapists will be aware which treatment they have been assigned to.

Study Groups

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Emotion Regulation Therapy - Attention Regulation (AR-ERT)

Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.

Group Type EXPERIMENTAL

Emotion Regulation Therapy - Attention Regulation (AR-ERT)

Intervention Type BEHAVIORAL

Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based AR-ERT. This intervention aims to build attention regulation skills (i.e., the ability to flexibly shift and sustain attention) by teaching participants exercises for Orienting their attention and Allowing the presence of negative emotions. Participants are taught to apply these skills to counteract reactive perseverative thinking when negative emotions arise as well as proactively engage with emotion-laden situations that trigger repetitive negative thinking.

Supportive Psychotherapy (SPT)

Individuals with repetitive negative thinking receiving Supportive Psychotherapy.

Group Type ACTIVE_COMPARATOR

Supportive Psychotherapy (SPT)

Intervention Type BEHAVIORAL

Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based SPT. This intervention addresses factors that may affect participants' repetitive negative thinking symptoms (for example, relationships, work, stress), and teaches skills for managing challenges by improving self-esteem and positive coping skills.

Interventions

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Emotion Regulation Therapy - Attention Regulation (AR-ERT)

Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based AR-ERT. This intervention aims to build attention regulation skills (i.e., the ability to flexibly shift and sustain attention) by teaching participants exercises for Orienting their attention and Allowing the presence of negative emotions. Participants are taught to apply these skills to counteract reactive perseverative thinking when negative emotions arise as well as proactively engage with emotion-laden situations that trigger repetitive negative thinking.

Intervention Type BEHAVIORAL

Supportive Psychotherapy (SPT)

Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based SPT. This intervention addresses factors that may affect participants' repetitive negative thinking symptoms (for example, relationships, work, stress), and teaches skills for managing challenges by improving self-esteem and positive coping skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults ages 18-60 years old
* Right-handed
* Living in Massachusetts
* Repetitive Negative Thinking (RNT) in the form of mental rituals, worries, and/or depressive ruminations is the primary reason for seeking treatment
* RNT significant enough to warrant intervention
* Fluent in English, willing to provide informed consent, and willing to comply with the study protocol
* Access to a device with an internet connection, camera, and microphone (e.g., computer, smart phone, tablet)
* Comfortable and capable of using a computer and completing reaction-time tasks

Exclusion Criteria

* History of head injury or neurologic disease, mental retardation, or borderline intellectual functioning that would interfere with ability to participate in the study.
* Impaired (or uncorrected) vision, medical illness, or medical treatment that would interfere with participation.
* Active suicidal or homicidal ideation or any features requiring a higher level of care.
* Lifetime psychotic disorder or bipolar disorder
* Substance or alcohol use disorder that would interfere with treatment.
* Current Attention Deficit Hyperactivity Disorder (ADHD) that would interfere with attentional tasks.
* Unstable dose of psychotropic medications or recent discontinuation of psychotropic medication.
* Current psychotherapy or plans to initiate such treatment during the study.
* Previous course of treatment with cognitive behavioral therapy and/or mindfulness/meditation for obsessive compulsive disorder (OCD), generalized anxiety disorder (GAD), or depression.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ryan Jane Jacoby

Clinical Psychologist, OCD and Related Disorders Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan J Jacoby, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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https://mghocd.org/attentionregulationstudy/

Attention Regulation Study website

Other Identifiers

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1K23MH120351-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P003768

Identifier Type: -

Identifier Source: org_study_id

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