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Emotion Regulation Therapy for Clinical Worry and Rumination (ERT)

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ClinicalTrials.gov Identifier: NCT04060940
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Kent State University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Douglas Mennin, Teachers College, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders and Symptoms Depression, Anxiety Generalized Anxiety Disorder Emotional Dysfunction Behavioral: Emotion Regulation Therapy: 8-session version Behavioral: Emotion Regulation Therapy: 16-session version Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants will be randomly assigned to an 8-session or 16-session version of ERT.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination
Actual Study Start Date : November 6, 2015
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Emotion Regulation Therapy: 8-session version
All participants will be randomly assigned to an 8-session or 16-session version of ERT with equal probability. Participants assigned to the 8-session version of ERT will receive 8 sessions of individualized therapy, each of which is 1-1.5 hours, on a weekly basis. Sessions 1-5 will be 1 hour long, sessions 6 and 7 will be 1.5 hours long, and session 8 will be one hour long, resulting in a total required time commitment of 9 hours over the course of 8 weeks.
Behavioral: Emotion Regulation Therapy: 8-session version
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 Name: Emotion Regulation Therapy (ERT)

Experimental: Emotion Regulation Therapy: 16-session version
All participants will be randomly assigned to an 8-session or 16-session version of ERT with equal probability. Participants assigned to the 16-session version of ERT will receive 16 sessions of individualized therapy, each of which is 1-1.5 hours, on a weekly basis. Sessions 1-9 will be 1 hour long, sessions 10-13 will be 1.5 hours long, and sessions 14-16 will be 1 hour long, resulting in a total required time commitment of 18 hours over the course of 16 weeks.
Behavioral: Emotion Regulation Therapy: 16-session version
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 Name: Emotion Regulation Therapy (ERT)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060940


Contacts
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Contact: Douglas S Mennin, PhD 212-678-6609 mennin@tc.columbia.edu

Locations
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United States, New York
Teachers College, Columbia University Recruiting
New York, New York, United States, 10027
Contact: Douglas S Mennin, PhD    212-678-6609    mennin@tc.columbia.edu   
Sponsors and Collaborators
Douglas Mennin
Kent State University
Weill Medical College of Cornell University

Publications of Results:
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Responsible Party: Douglas Mennin, Professor of Clinical Psychology, Teachers College, Columbia University
ClinicalTrials.gov Identifier: NCT04060940     History of Changes
Other Study ID Numbers: 18-019
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Douglas Mennin, Teachers College, Columbia University:
Emotion Regulation
Distress Disorders
Anxiety
Depression
Additional relevant MeSH terms:
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Disease
Depression
Anxiety Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders