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Emotion Regulation Therapy for Clinical Worry and Rumination (ERT)

Primary Purpose

Anxiety Disorders and Symptoms, Depression, Anxiety, Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion Regulation Therapy: 8-session version
Emotion Regulation Therapy: 16-session version
Sponsored by
Douglas Mennin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms focused on measuring Emotion Regulation, Distress Disorders, Anxiety, Depression

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teachers College, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Emotion Regulation Therapy: 8-session version

Emotion Regulation Therapy: 16-session version

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Worry
Penn State Worry Questionnaire (PSWQ)
Changes in Rumination
Rumination-Reflection Questionnaire (RRQ)
Changes in Functional Impairment
Sheehan Disability Scale (SDS)
Changes in Life Satisfaction
Quality of Life Inventory (QOLI)
Changes in Diagnostic Criteria, Severity, and Improvement
Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV

Secondary Outcome Measures

Changes in Anxiety and Depression
Mood and Anxiety Symptom Questionnaire (MASQ)
Model-Related Changes: Attention Regulation
Attentional Control Scale (ACS)
Model-Related Changes: Metacognitive Regulation
Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ)

Full Information

First Posted
June 4, 2019
Last Updated
May 13, 2022
Sponsor
Douglas Mennin
Collaborators
Kent State University, Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04060940
Brief Title
Emotion Regulation Therapy for Clinical Worry and Rumination
Acronym
ERT
Official Title
Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2015 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Douglas Mennin
Collaborators
Kent State University, Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms, Depression, Anxiety, Generalized Anxiety Disorder, Emotional Dysfunction
Keywords
Emotion Regulation, Distress Disorders, Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will be randomly assigned to an 8-session or 16-session version of ERT.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotion Regulation Therapy: 8-session version
Arm Type
Experimental
Arm Description
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.
Arm Title
Emotion Regulation Therapy: 16-session version
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Therapy: 8-session version
Other Intervention Name(s)
Emotion Regulation Therapy (ERT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation Therapy: 16-session version
Other Intervention Name(s)
Emotion Regulation Therapy (ERT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Worry
Description
Penn State Worry Questionnaire (PSWQ)
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
Title
Changes in Rumination
Description
Rumination-Reflection Questionnaire (RRQ)
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
Title
Changes in Functional Impairment
Description
Sheehan Disability Scale (SDS)
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
Title
Changes in Life Satisfaction
Description
Quality of Life Inventory (QOLI)
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
Title
Changes in Diagnostic Criteria, Severity, and Improvement
Description
Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV
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
Secondary Outcome Measure Information:
Title
Changes in Anxiety and Depression
Description
Mood and Anxiety Symptom Questionnaire (MASQ)
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
Title
Model-Related Changes: Attention Regulation
Description
Attentional Control Scale (ACS)
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
Title
Model-Related Changes: Metacognitive Regulation
Description
Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ)
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
Other Pre-specified Outcome Measures:
Title
Neural Changes using fMRI
Description
Resting State and Behavioral Tasks (i.e., Attentional Shifting Task, Emotion Regulation Task, Approach-Avoidance Conflict Task)
Time Frame
Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment)
Title
Cardiac Changes using HRV
Description
Resting State
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
Title
Inflammatory Markers
Description
Blood Draw (i.e., IL-6, TNF-alpha, and the C-reactive protein)
Time Frame
Pre-Treatment, Post-Treatment (either 8- or 16- weeks after starting treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Teachers College, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29504794
Citation
Mennin DS, Fresco DM, O'Toole MS, Heimberg RG. A randomized controlled trial of emotion regulation therapy for generalized anxiety disorder with and without co-occurring depression. J Consult Clin Psychol. 2018 Mar;86(3):268-281. doi: 10.1037/ccp0000289.
Results Reference
result
PubMed Identifier
29704969
Citation
Renna ME, Quintero JM, Soffer A, Pino M, Ader L, Fresco DM, Mennin DS. A Pilot Study of Emotion Regulation Therapy for Generalized Anxiety and Depression: Findings From a Diverse Sample of Young Adults. Behav Ther. 2018 May;49(3):403-418. doi: 10.1016/j.beth.2017.09.001. Epub 2017 Sep 8.
Results Reference
result
PubMed Identifier
28220089
Citation
Renna ME, Quintero JM, Fresco DM, Mennin DS. Emotion Regulation Therapy: A Mechanism-Targeted Treatment for Disorders of Distress. Front Psychol. 2017 Feb 6;8:98. doi: 10.3389/fpsyg.2017.00098. eCollection 2017.
Results Reference
result

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Emotion Regulation Therapy for Clinical Worry and Rumination

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