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Obsessive-Compulsive DisorderNCT04225624

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

A study testing Emotion Regulation Therapy - Attention Regulation (AR-ERT) and Supportive Psychotherapy (SPT) in people with Obsessive-Compulsive Disorder and Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Emotion Regulation Therapy - Attention Regulation (AR-ERT) and Supportive Psychotherapy (SPT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
30 Apr 2021to 9 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Targeting Attentional and Cognitive Control to Enhance the Transdiagnostic Treatment of Repetitive Negative Thinking

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.

Read the detailed description

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. Phase 1 is an open pilot trial in which participants will be assigned to eight 60 minute sessions (over 8 weeks) of Emotion Regulation Therapy-Attention Regulation (AR-ERT). In Phase 2, participants will be randomly assigned (like the flip of a coin) to receive eight 60 minute sessions (over 8 weeks) of either: 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 - Phase 2 only). 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.

Being tested
Emotion Regulation Therapy - Attention Regulation (AR-ERT), Supportive Psychotherapy (SPT)
Keywords
OCD, GAD, MDD, Rumination, Obsession, Worry, Attention
Medical subject headings
Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Depressive Disorder, Major, Rumination Syndrome, Obsessive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotion Regulation Therapy - Attention Regulation (AR-ERT)Behavioural

    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)Behavioural

    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.

Study groups in NCT04225624
Study groupRoleWhat they receive
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)ExperimentalIndividuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
Receives: Behavioral: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
Phase 2: Supportive Psychotherapy (SPT)Active comparatorIndividuals with repetitive negative thinking receiving Supportive Psychotherapy.
Receives: Behavioral: Supportive Psychotherapy (SPT)
Phase 1: Pilot Testing PhaseExperimentalIndividuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
Receives: Behavioral: Emotion Regulation Therapy - Attention Regulation (AR-ERT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)
  1. 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

    16-item self-report measure of the tendency to engage in excessive, uncontrollable, and generalized worry (e.g., "I am always worrying about something"). Total scores range from 16-80, with higher scores indicating more worry (i.e., worse outcomes).

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

  2. 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

    22-item self-report measure of the tendency to ruminate or dwell on one's distress and it's possible causes and consequences when feeling down, sad, or depressed (e.g., "Think about all your shortcomings, failings, faults, mistakes"). Total scores range from 22-88, with higher scores indicating more rumination (i.e., worse outcomes).

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

  3. 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

    The ROCS is a 33-item self-report measure that assesses the frequency of various mental responses to obsessional thoughts or images in the past month with 3 sub-scales: Mental Neutralizing, Acceptance, and Rumination on OCD symptoms (no total score is used). The Mental Neutralizing Sub-Scale is 18 items and specifically assesses mental rituals including arguing with oneself, reconstructing rituals, effort against thoughts, and distraction (e.g., "I feel compelled to collect all arguments that refute the intrusive thought or image"). Total scores (which are an average of the subscale items) range from 0-4, with higher scores indicating more mental rituals (i.e., worse outcomes).

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

  4. 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

    10-item clinician-administered interview measure of past week symptom severity of obsessions and compulsions including: time, interference, distress, resistance, and control. Total scores range from 0-40, with higher scores indicating higher levels of OCD symptom severity (i.e., worse outcomes).

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

  5. 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

    14-item structured, clinician-administered interview measure of past week anxiety symptom severity including: anxious mood, tension, fears, insomnia, cognitive symptoms, depressed mood, somatic (muscular, sensory) symptoms, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and observed behavior. Total scores range from 0-56, with higher scores indicating higher levels of generalized anxiety symptoms (i.e., worse outcomes).

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

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

    17-item interview measure of past week depression symptom severity including: depressed mood, interest in work and activities, insomnia (early, middle, and late), genital symptoms, gastrointestinal somatic symptoms, loss of weight, general somatic symptoms, feelings of guilt, suicide, psychic anxiety, somatic anxiety, hypochondriasis, insight, agitation, retardation. Total scores range from 0-52, with higher scores indicating more depression (i.e., worse outcomes).

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

  7. Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial

    5-item self-report scale assessing disability in work, home management, social leisure activities, private leisure activities, and the ability to form and maintain close relationships. Total scores range from 0-40, with higher scores indicating more functional impairment (i.e., worse outcomes).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start30 Apr 2021
  3. Primary completion22 Jan 2025
  4. Study completion9 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04225624
Sponsor's protocol ID
2019P003768
Other IDs
1K23MH120351-01A1
Status last verified
Feb 2026
First submitted
7 Jan 2020
Last updated
10 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators do not have specific plans to share individual participant data in order to preserve the confidentiality of our participants. Any data that is shared would only be done so after executing a formal Data Use Agreement from Massachusetts General Hospital.

Questions about this trial

What is this clinical trial studying?

A study testing Emotion Regulation Therapy - Attention Regulation (AR-ERT) and Supportive Psychotherapy (SPT) in people with Obsessive-Compulsive Disorder and Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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