Anxiety Disorders and Symptoms, Depression, Anxiety, Emotional Dysfunction, Generalized Anxiety Disorder
Conditions
Keywords
Emotion Regulation, Distress Disorders, Anxiety, Depression
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.
Interventions
BEHAVIORALEmotion 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.
BEHAVIORALEmotion 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.
Sponsors
Kent State University
Weill Medical College of Cornell University
Douglas Mennin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will be randomly assigned to an 8-session or 16-session version of ERT.
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Functional Impairment | 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 | Sheehan Disability Scale (SDS) |
| Changes in Worry | 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 | Penn State Worry Questionnaire (PSWQ) |
| Changes in Rumination | 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 | Rumination-Reflection Questionnaire (RRQ) |
| Changes in Diagnostic Criteria, Severity, and Improvement | 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 | Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV |
| Changes in Life Satisfaction | 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 | Quality of Life Inventory (QOLI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ) |
| 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 | Mood and Anxiety Symptom Questionnaire (MASQ) |
| 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 | Attentional Control Scale (ACS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | Resting State and Behavioral Tasks (i.e., Attentional Shifting Task, Emotion Regulation Task, Approach-Avoidance Conflict Task) |
| Inflammatory Markers | Pre-Treatment, Post-Treatment (either 8- or 16- weeks after starting treatment) | Blood Draw (i.e., IL-6, TNF-alpha, and the C-reactive protein) |
| 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 | Resting State |
Countries
United States
Outcome results
None listed