Emotion Regulation Therapy for Clinical Worry and Rumination (ERT)

Douglas Mennin

Status: Completed

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

Treatments: Behavioral: Emotion Regulation Therapy: 8-session version; Behavioral: Emotion Regulation Therapy: 16-session version

Study type: Interventional

Funder types: Other

Identifiers

NCT04060940

18-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Emotion Regulation Therapy: 8-session version

Experimental group

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.

Treatment:

Behavioral: Emotion Regulation Therapy: 8-session version

Emotion Regulation Therapy: 16-session version

Experimental group

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.

Treatment:

Behavioral: Emotion Regulation Therapy: 16-session version