Clinical Trials Directory

Trials / Completed

CompletedNCT04225624

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
65 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEmotion 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.
BEHAVIORALSupportive 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.

Timeline

Start date
2021-04-30
Primary completion
2025-01-22
Completion
2025-04-09
First posted
2020-01-13
Last updated
2026-03-10
Results posted
2026-03-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04225624. Inclusion in this directory is not an endorsement.