Emotion Regulation Therapy for Clinical Worry and Rumination

NCT04060940 | Completed DMC

• 1 other identifier: 18-019
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders and Symptoms; Depression, Anxiety; Generalized Anxiety Disorder; Emotional Dysfunction

Keywords

Emotion Regulation; Distress Disorders; Anxiety; Depression

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Changes in Anxiety and Depression

  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

• Model-Related Changes: Attention Regulation

  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

• Model-Related Changes: Metacognitive Regulation

  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 (3)

• Neural Changes using fMRI

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

• Cardiac Changes using HRV

  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

• Inflammatory Markers

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

Study Arms (2)

Emotion Regulation Therapy: 8-session version

EXPERIMENTAL

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: 16-session version

EXPERIMENTAL

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

Interventions

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.

Also known as: Emotion Regulation Therapy (ERT)

Emotion Regulation Therapy: 8-session version

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.

Also known as: Emotion Regulation Therapy (ERT)

Emotion Regulation Therapy: 16-session version

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Douglas Mennin: lead
• Kent State University: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (4)

• 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.

  PMID: 29504794 RESULT

• 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.

  PMID: 29704969 RESULT

• 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.

  PMID: 28220089 RESULT

• Renna ME, Spaeth PE, Quintero JM, O'Toole MS, Sandman CF, Fresco DM, Mennin DS. A randomized controlled trial comparing two doses of emotion regulation therapy: Preliminary evidence that gains in attentional and metacognitive regulation reduce worry, rumination, and distress. Behav Res Ther. 2023 Oct 21;170:104420. doi: 10.1016/j.brat.2023.104420. Online ahead of print.

  PMID: 39491310 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Generalized Anxiety Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Model Details: All participants will be randomly assigned to an 8-session or 16-session version of ERT.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: August 19, 2019
• Study Start: November 6, 2015
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)