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NCT04225624

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

Completed NA Results posted Last updated 10 March 2026
What this trial tests

NA trial testing Emotion Regulation Therapy - Attention Regulation (AR-ERT) in Obsessive-Compulsive Disorder in 65 participants. Completed in 9 April 2025.

Timeline
30 April 2021
Primary endpoint
22 January 2025
9 April 2025

Quick facts

Lead sponsorMassachusetts General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment65
Start date30 April 2021
Primary completion22 January 2025
Estimated completion9 April 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 60, any sex, with Obsessive-Compulsive Disorder or Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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
GroupValue95% CI
Phase 1: Pilot Testing Phase45.67± 5.86
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)45.29± 5.69
Phase 2: Supportive Psychotherapy (SPT)45.94± 5.76
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase31.33± 15.04
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)34.85± 11.33
Phase 2: Supportive Psychotherapy (SPT)36.64± 8.61
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase27.00± 5.29
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)25.88± 10.33
Phase 2: Supportive Psychotherapy (SPT)31.96± 11.96
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)29.43± 11.71
Phase 2: Supportive Psychotherapy (SPT)31.52± 12.96
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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).

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase62.33± 10.50
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)67.83± 11.65
Phase 2: Supportive Psychotherapy (SPT)67.17± 9.96
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase58.00± 13.23
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)63.35± 10.83
Phase 2: Supportive Psychotherapy (SPT)63.81± 8.75
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase51.33± 12.66
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)58.16± 11.85
Phase 2: Supportive Psychotherapy (SPT)61.18± 10.63
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)60.00± 12.10
Phase 2: Supportive Psychotherapy (SPT)60.26± 11.35
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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).

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase58.33± 7.23
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)60.63± 10.73
Phase 2: Supportive Psychotherapy (SPT)61.55± 11.31
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase54.67± 7.51
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)54.54± 13.89
Phase 2: Supportive Psychotherapy (SPT)54.19± 12.64
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase53.67± 9.07
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)49.20± 12.81
Phase 2: Supportive Psychotherapy (SPT)49.96± 12.23
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)51.81± 12.87
Phase 2: Supportive Psychotherapy (SPT)51.48± 13.08
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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) ran

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase2.65± 0.08
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)2.05± 0.53
Phase 2: Supportive Psychotherapy (SPT)1.97± 0.75
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase2.04± 0.45
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)1.76± 0.53
Phase 2: Supportive Psychotherapy (SPT)1.88± 0.66
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase1.50± 0.43
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)1.56± 0.47
Phase 2: Supportive Psychotherapy (SPT)1.74± 0.76
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)1.58± 0.47
Phase 2: Supportive Psychotherapy (SPT)1.56± 0.81
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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).

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase20.33± 5.13
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)23.81± 3.76
Phase 2: Supportive Psychotherapy (SPT)22.84± 5.92
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase18.67± 4.93
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)21.42± 1.83
Phase 2: Supportive Psychotherapy (SPT)19.25± 3.91
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase17.00± 3.61
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)15.92± 4.62
Phase 2: Supportive Psychotherapy (SPT)17.69± 6.42
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)18.33± 5.99
Phase 2: Supportive Psychotherapy (SPT)17.94± 6.76
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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).

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase20.67± 14.36
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)22.84± 5.53
Phase 2: Supportive Psychotherapy (SPT)22.71± 6.91
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase17.00± 9.54
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)18.00± 6.63
Phase 2: Supportive Psychotherapy (SPT)15.86± 5.94
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase18.67± 14.47
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)13.60± 6.56
Phase 2: Supportive Psychotherapy (SPT)14.29± 7.51
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)15.17± 5.58
Phase 2: Supportive Psychotherapy (SPT)12.93± 5.86
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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).

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase14.33± 8.50
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)18.61± 4.44
Phase 2: Supportive Psychotherapy (SPT)18.48± 5.30
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase13.33± 8.50
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)15.15± 5.09
Phase 2: Supportive Psychotherapy (SPT)13.39± 5.49
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase13.67± 11.37
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)10.96± 5.68
Phase 2: Supportive Psychotherapy (SPT)11.93± 5.50
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)12.30± 4.89
Phase 2: Supportive Psychotherapy (SPT)11.54± 5.36
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 Secondary · Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)

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).

Week 0
GroupValue95% CI
Phase 1: Pilot Testing Phase22.67± 8.02
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)24.68± 5.49
Phase 2: Supportive Psychotherapy (SPT)24.45± 6.46
Week 4
GroupValue95% CI
Phase 1: Pilot Testing Phase16.33± 12.58
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)15.77± 7.91
Phase 2: Supportive Psychotherapy (SPT)17.33± 7.70
Week 8
GroupValue95% CI
Phase 1: Pilot Testing Phase11.33± 8.14
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)13.16± 8.26
Phase 2: Supportive Psychotherapy (SPT)16.00± 8.78
Week 20
GroupValue95% CI
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)11.71± 8.04
Phase 2: Supportive Psychotherapy (SPT)11.81± 8.40

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1: Pilot Testing Phase
Serious: 0/3 (0%)
Deaths: 0/3
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
Serious: 0/31 (0%)
Deaths: 0/31
Phase 2: Supportive Psychotherapy (SPT)
Serious: 0/31 (0%)
Deaths: 0/31
Other adverse events (8 terms — click to expand)

ReactionSystemPhase 1: Pilot Testing PhasePhase 2: Emotion Regulatio…Phase 2: Supportive Psycho…
Cold/Flu/COVIDInfections and infestations
Increased depression/anxiety/stressPsychiatric disorders
Hip, neck, back, foot/ankle injury or stiffness or tendonitisMusculoskeletal and connective tissue disorders
EEG discomfortGeneral disorders
MigraineNervous system disorders
Yeast infection / UTIInfections and infestations
AllergiesImmune system disorders
Kidney failureRenal and urinary disorders

Data from ClinicalTrials.gov NCT04225624 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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