Emotion Regulation Therapy for Clinical Worry and Rumination

Generalized Anxiety Disorder Clinical Trial

— ERT  

Official title:

Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060940
• Other study ID #: 18-019
• Status: Completed
• Phase: N/A
• Start date: November 6, 2015
• Est. completion date: April 26, 2022

Study information

• Verified date: May 2022
• Source: Teachers College, Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Depression
• Depression, Anxiety
• Disease
• Emotional Dysfunction
• Generalized Anxiety Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Douglas Mennin	Kent State University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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.b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neural Changes using fMRI	Resting State and Behavioral Tasks (i.e., Attentional Shifting Task, Emotion Regulation Task, Approach-Avoidance Conflict Task)	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment)
Other	Cardiac Changes using HRV	Resting State	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
Other	Inflammatory Markers	Blood Draw (i.e., IL-6, TNF-alpha, and the C-reactive protein)	Pre-Treatment, Post-Treatment (either 8- or 16- weeks after starting treatment)
Primary	Changes in Worry	Penn State Worry Questionnaire (PSWQ)	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
Primary	Changes in Rumination	Rumination-Reflection Questionnaire (RRQ)	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
Primary	Changes in Functional Impairment	Sheehan Disability Scale (SDS)	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
Primary	Changes in Life Satisfaction	Quality of Life Inventory (QOLI)	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
Primary	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	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	Changes in Anxiety and Depression	Mood and Anxiety Symptom Questionnaire (MASQ)	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	Model-Related Changes: Attention Regulation	Attentional Control Scale (ACS)	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
Secondary	Model-Related Changes: Metacognitive Regulation	Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ)	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