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Anxiety Disorders and SymptomsERTNCT04060940

Emotion Regulation Therapy for Clinical Worry and Rumination

A study testing Emotion Regulation Therapy: 8-session version and Emotion Regulation Therapy: 16-session version in people with Anxiety Disorders and Symptoms and Depression, Anxiety, run by Douglas Mennin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 29 years
What is being tested?
Emotion Regulation Therapy: 8-session version and Emotion Regulation Therapy: 16-session version
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
6 Nov 2015to 26 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Teachers College, Columbia University

    New York, New York, 10027

Other trials in United States

About this study

Official title: Emotion Regulation Therapy for Young Adults With Clinical Worry and Rumination

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.

Read the 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.

Being tested
Emotion Regulation Therapy: 8-session version, Emotion Regulation Therapy: 16-session version
Keywords
Emotion Regulation, Distress Disorders, Anxiety, Depression
Medical subject headings
Anxiety Disorders, Depression, Generalized Anxiety Disorder, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotion Regulation Therapy: 8-session versionBehavioural

    Also called Emotion Regulation Therapy (ERT)

    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 versionBehavioural

    Also called Emotion Regulation Therapy (ERT)

    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.

Study groups in NCT04060940
Study groupRoleWhat they receive
Emotion Regulation Therapy: 8-session versionExperimentalAll 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.
Receives: Behavioral: Emotion Regulation Therapy: 8-session version
Emotion Regulation Therapy: 16-session versionExperimentalAll 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.
Receives: Behavioral: Emotion Regulation Therapy: 16-session version

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Worry

    Penn State Worry Questionnaire (PSWQ)

    Measured: 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

  2. Changes in Rumination

    Rumination-Reflection Questionnaire (RRQ)

    Measured: 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

  3. Changes in Functional Impairment

    Sheehan Disability Scale (SDS)

    Measured: 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

  4. Changes in Life Satisfaction

    Quality of Life Inventory (QOLI)

    Measured: 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

  5. 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

    Measured: 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)
  1. Changes in Anxiety and Depression

    Mood and Anxiety Symptom Questionnaire (MASQ)

    Measured: 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

  2. Model-Related Changes: Attention Regulation

    Attentional Control Scale (ACS)

    Measured: 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

  3. Model-Related Changes: Metacognitive Regulation

    Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2019
  2. Study start6 Nov 2015
  3. Primary completion26 Apr 2022
  4. Study completion26 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All participants will be randomly assigned to an 8-session or 16-session version of ERT.
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04060940
Sponsor's protocol ID
18-019
Acronym
ERT
Status last verified
May 2022
First submitted
4 Jun 2019
Last updated
17 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29504794
  • 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.

    PubMed 29704969
  • 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.

    PubMed 28220089
  • 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.

    PubMed 39491310

Questions about this trial

What is this clinical trial studying?

A study testing Emotion Regulation Therapy: 8-session version and Emotion Regulation Therapy: 16-session version in people with Anxiety Disorders and Symptoms and Depression, Anxiety, run by Douglas Mennin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Worry (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04060940, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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