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

NCT04225624 | Completed Results DMC

• 2 other identifiers: 2019P0037681K23MH120351-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Generalized Anxiety Disorder; Major Depressive Disorder; Obsessive-Compulsive Disorder

Keywords

OCD; GAD; MDD; Rumination; Obsession; Worry; Attention

Outcome Measures

Primary Outcomes (1)

• Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

  15-item self-report measure of transdiagnostic repetitive negative thinking that includes items about thoughts as repetitive, intrusive, unproductive, and capturing mental capacity (e.g., "I think about many problems without solving any of them"). Total scores range from 0-60, with higher scores indicating more repetitive negative thinking (i.e., worse outcomes).

  Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

Secondary Outcomes (7)

• Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

  Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

• Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

  Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

• Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

  Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

• OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

  Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

• Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

  Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

Study Arms (3)

Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)

EXPERIMENTAL

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

Behavioral: Emotion Regulation Therapy - Attention Regulation (AR-ERT)

Phase 2: Supportive Psychotherapy (SPT)

ACTIVE COMPARATOR

Individuals with repetitive negative thinking receiving Supportive Psychotherapy.

Behavioral: Supportive Psychotherapy (SPT)

Phase 1: Pilot Testing Phase

EXPERIMENTAL

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

Behavioral: Emotion Regulation Therapy - Attention Regulation (AR-ERT)

Interventions

Supportive Psychotherapy (SPT) 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.

Phase 2: Supportive Psychotherapy (SPT)

Emotion Regulation Therapy - Attention Regulation (AR-ERT) 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.

Phase 1: Pilot Testing Phase; Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Attention Regulation Study website

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Depressive Disorder, Major; Rumination Syndrome; Obsessive Behavior

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Ryan J. Jacoby, Ph.D.
• Organization: Massachusetts General Hospital

rjjacoby@mgh.harvard.edu

617-724-4167

Study Officials

• Ryan J Jacoby, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, Center for OCD and Related Disorders

Model Details: Phase 1: All participants will receive AR-ERT. Phase 2: At the baseline visit, eligible participants will be randomized (1:1 in parallel) to AR-ERT or SPT.

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: April 30, 2021
• Primary Completion: January 22, 2025
• Study Completion: April 9, 2025
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)