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Completed

NCT Number: NCT04060940

Emotion Regulation Therapy for Clinical Worry and Rumination

The present project aims to broaden our understanding of neural mechanisms which may underlie change in symptoms occurring over the course of Emotion Regulation Therapy. Specifically, we aim to examine neural changes as a result of either an 8-session or 16-session version of the treatment.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Teachers College, Columbia University

New York, 10027, United States

About this study

This study aims to examine the utility of Emotion Regulation Training (ERT) in reducing symptoms of anxiety and/or depression in young adults aged 18 to 29 years old. Additionally, we are interested in assessing neural, cardiac, and immunological changes associated with psychological symptom reduction in these individuals. Lastly, we are interested in examining whether an abbreviated 8-session version of ERT produces similar results to a longer (16-session) version of ERT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-29 years during the time of participation
  • Meets diagnostic criteria for an anxiety and/or depressive disorder
  • Endorses significant worry and/or rumination

Exclusion criteria

  • Active suicidal intent
  • Current substance dependence disorder (within the past year)
  • Current or past psychotic disorder, bipolar-I disorder, or dementia
  • Not currently received any other form of psychosocial treatment
  • Not being on a stabilized dose of medication (less than 3 months) during enrollment
  • Pregnancy or plans to become pregnant during active participation
  • Irremovable metal objects in the body
  • Neurological disorder, traumatic brain injury, or loss of consciousness
  • Tattoos if/when posing risks for involvement in the MRI component of the study

Treatment and study plan

Emotion Regulation Therapy: 8-session version

Behavioral

Emotion Regulation Therapy will be administered over 8 individual sessions on a weekly basis, resulting in a total required time commitment of 9 hours over the course of 8 weeks. The initial stage of treatment focuses on psychoeducation about anxiety and depression, individual patterns of these behaviors, emotions in recent situations, and self-monitoring of worry, anxiety, and depression. The sessions focus on the development of skills that help regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, and soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining sessions focus on terminating therapy, relapse prevention, and future goals.

Other names: Emotion Regulation Therapy (ERT)

Emotion Regulation Therapy: 16-session version

Behavioral

Emotion Regulation Therapy will be administered over 16 individual sessions on a weekly basis, resulting in a total required time commitment of 18 hours over the course of 16 weeks. The initial stage of treatment focuses on psychoeducation about anxiety and depression, individual patterns of these behaviors, emotions in recent situations, and self-monitoring of worry, anxiety, and depression. The sessions focus on the development of skills that help regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, and soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining sessions focus on terminating therapy, relapse prevention, and future goals.

Other names: Emotion Regulation Therapy (ERT)

Primary outcomes

  1. Changes in Worry

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Penn State Worry Questionnaire (PSWQ)

  2. Changes in Rumination

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Rumination-Reflection Questionnaire (RRQ)

  3. Changes in Functional Impairment

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Sheehan Disability Scale (SDS)

  4. Changes in Life Satisfaction

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Quality of Life Inventory (QOLI)

  5. Changes in Diagnostic Criteria, Severity, and Improvement

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV

Secondary outcomes

  1. Changes in Anxiety and Depression

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Mood and Anxiety Symptom Questionnaire (MASQ)

  2. Model-Related Changes: Attention Regulation

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Attentional Control Scale (ACS)

  3. Model-Related Changes: Metacognitive Regulation

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ)

Other outcomes

  1. Neural Changes using fMRI

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment)

    Resting State and Behavioral Tasks (i.e., Attentional Shifting Task, Emotion Regulation Task, Approach-Avoidance Conflict Task)

  2. Cardiac Changes using HRV

    Time frame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up

    Resting State

  3. Inflammatory Markers

    Time frame: Pre-Treatment, Post-Treatment (either 8- or 16- weeks after starting treatment)

    Blood Draw (i.e., IL-6, TNF-alpha, and the C-reactive protein)

Sponsors and collaborators

Lead sponsor

Douglas Mennin

Other

Collaborators

  • Kent State University
  • Weill Medical College of Cornell University

Registry information

Official study title

Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination

Acronym: ERT

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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