Clinical trial NCT04060940: Emotion Regulation Therapy for Clinical Worry and Rumination
Official title: Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depression, Anxiety
Generalized Anxiety Disorder
Emotional Dysfunction
Keywords: Emotion Regulation
Distress Disorders
Anxiety
Depression
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Kent State University
name: Weill Medical College of Cornell University
First posted: 2019-08-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be randomly assigned to an 8-session or 16-session version of ERT.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Worry
timeFrame: 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
measure: Changes in Rumination
timeFrame: 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
measure: Changes in Functional Impairment
timeFrame: 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
measure: Changes in Life Satisfaction
timeFrame: 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
measure: Changes in Diagnostic Criteria, Severity, and Improvement
timeFrame: 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 outcomes:
measure: Changes in Anxiety and Depression
timeFrame: 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
measure: Model-Related Changes: Attention Regulation
timeFrame: 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
measure: Model-Related Changes: Metacognitive Regulation
timeFrame: 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 outcomes:
measure: Neural Changes using fMRI
timeFrame: Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment)
measure: Cardiac Changes using HRV
timeFrame: 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
measure: Inflammatory Markers
timeFrame: Pre-Treatment, Post-Treatment (either 8- or 16- weeks after starting treatment)
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
References:
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.
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.
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.