Clinical trial NCT04225624: Improving Attentional and Cognitive Control in the Psychological Treatment of Intrusive Thoughts
Official title: Targeting Attentional and Cognitive Control to Enhance the Transdiagnostic Treatment of Repetitive Negative Thinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Generalized Anxiety Disorder
Major Depressive Disorder
Keywords: OCD
GAD
MDD
Rumination
Obsession
Worry
Attention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-01-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the baseline visit, eligible participants will be randomized (1:1 in parallel) to AR-ERT or SPT.
Primary purpose: TREATMENT

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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in transdiagnostic repetitive negative thinking at 8 weeks (as measured by the Perseverative Thinking Questionnaire)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
Secondary outcomes:
measure: Change from baseline in worry at 8 weeks (as measured by the Penn State Worry Questionnaire)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
measure: Change from baseline in rumination at 8 weeks (as measured by the Rumination Response Scale)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
measure: Change from baseline in mental rituals at 8 weeks (as measured by the Rumination on Obsessions and Compulsions Scale)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
measure: Change from baseline in OCD symptom severity at 8 weeks (as measured by the Yale-Brown Obsessive-Compulsive Scale)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
measure: Change from baseline in generalized anxiety symptom severity (as measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
measure: Change from baseline in depression symptom severity (as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
measure: Change from baseline in functional impairment (as measured by the Work and Social Adjustment Scale)
timeFrame: Change from Week 0 (baseline) to post-treatment (week 8)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan J Jacoby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: