Distress, EmotionalERT-PNCT04615416
Emotion Regulation Training Via Telehealth During the COVID-19 Pandemic
A study testing Emotion Regulation Training via Telehealth in people with Distress, Emotional and Emotional Dysfunction, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distress, Emotional, Emotional Dysfunction, Anxiety
- What is being tested?
- Emotion Regulation Training via Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 6 Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years during the time of participation
- Endorses distress and worry/rumination exacerbated by the COVID-19 pandemic
- Access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the Internet
Who cannot join
- Active suicidal intent
- Current substance dependence disorder (within the past year)
- Current or past psychotic disorder, Bipolar-I disorder, or dementia
- Primary DSM-5 diagnosis of borderline or narcissistic personality disorder
- Currently receiving any other form of psychosocial treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Teachers College, Columbia University
New York, New York, 10027
About this study
Official title: Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.
Read the detailed description
The present study is evaluating whether this ERT treatment program delivered via telehealth demonstrates efficacy in: 1) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination); 2) improving outcomes specific to the ERT mechanism-based model (e.g., attentional control, decentering, reappraisal); 3) improving quality of life and functioning, for adults aged 18-65 years old.
- Conditions
- Distress, Emotional, Emotional Dysfunction, Anxiety, Depression
- Being tested
- Emotion Regulation Training via Telehealth
- Keywords
- Emotion Regulation, Distress Disorders, Anxiety, Depression, COVID-19 Pandemic, Telehealth
- Medical subject headings
- Anxiety Disorders, Depression, Emotional Regulation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Training via TelehealthBehavioural
Also called Emotion Regulation Therapy (ERT)
The initial stage of treatment focuses on psychoeducation about anxiety/depression, the impact that these cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/anxiety/depression. The sessions focus on the development of skills that help understand and regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, 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 session focuses on terminating therapy, relapse prevention, and future goals. An Internet-based online platform will be used to promote engagement with and increase accessibility to between-session skills practice and treatment-related activities (e.g., self-monitoring, session summaries, worksheets).
| Study group | Role | What they receive |
|---|---|---|
| Emotion Regulation Training via Telehealth | Experimental | All participants will receive 9 sessions of Emotion Regulation Training delivered via telehealth. These individualized therapy sessions are 1-hour in length and occur semi-weekly over the course of four weeks. Receives: Behavioral: Emotion Regulation Training via Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)
Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)
Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate better outcomes)
Measured: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Secondary outcomes (10)
Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate worse outcomes)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Depression Symptoms
Quick Inventory of Depressive Symptoms(QUIDS)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Distress
Distress Thermometer (DT)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)
Scale: 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)
Scale = 1-5 (minimum = 3; maximum = 15; higher scores indicate worse outcomes)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)
Scale = 1-5 (minimum = 6; maximum = 30; higher scores indicate better outcomes)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)
Scale = 1-5 (minimum = 5; maximum = 25; higher scores indicate better outcomes)
Measured: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)
Scale = 1-4 (minimum = 6; maximum = 24; higher scores indicate better outcomes)
Measured: Semi-weekly over the course of four weeks
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
Scale = 1-4 (minimum = 4; maximum = 16; higher scores indicate better outcomes)
Measured: Post-Treatment (4-5 weeks after starting treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 May 2020
- Primary completion1 Jun 2022
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive a 9-session version of Emotion Regulation Training delivered semi-weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based Online platform to supplement the content covered in each session.
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Douglas Mennin, Teachers College, Columbia University
- Investigators
- Douglas S Mennin, Ph.D., Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615416
- Sponsor's protocol ID
- 20-269
- Acronym
- ERT-P
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2020
- Last updated
- 21 Nov 2024
- 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 29504794Renna 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial of Emotion Regulation Training Via Telehealth for Distressed Adults During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04615416
- Acronym / sponsor ID
- ERT-P / 20-269
- Conditions
- Distress, Emotional, Emotional Dysfunction, Anxiety, Depression
- Keywords
- Emotion Regulation, Distress Disorders, Anxiety, Depression, COVID-19 Pandemic, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the COVID-19 pandemic, with the overarching goal of helping residents of New York adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.
Detailed description
The present study is evaluating whether this ERT treatment program delivered via telehealth demonstrates efficacy in: 1) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination); 2) improving outcomes specific to the ERT mechanism-based model (e.g., attentional control, decentering, reappraisal); 3) improving quality of life and functioning, for adults aged 18-65 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive a 9-session version of Emotion Regulation Training delivered semi-weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based Online platform to supplement the content covered in each session.
| Arm | Type | Receives |
|---|---|---|
| Emotion Regulation Training via Telehealth | Experimental | Behavioral: Emotion Regulation Training via TelehealthAll participants will receive 9 sessions of Emotion Regulation Training delivered via telehealth. These individualized therapy sessions are 1-hour in length and occur semi-weekly over the course of four weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years during the time of participation
- Endorses distress and worry/rumination exacerbated by the COVID-19 pandemic
- Access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the Internet
Key exclusion criteria (5 listed)
- Active suicidal intent
- Current substance dependence disorder (within the past year)
- Current or past psychotic disorder, Bipolar-I disorder, or dementia
- Primary DSM-5 diagnosis of borderline or narcissistic personality disorder
- Currently receiving any other form of psychosocial treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation Training via TelehealthAlso: Emotion Regulation Therapy (ERT)The initial stage of treatment focuses on psychoeducation about anxiety/depression, the impact that these cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/anxiety/depression. The sessions focus on the development of skills that help understand and regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, 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 session focuses on terminating therapy, relapse prevention, and future goals. An Internet-based online platform will be used to promote engagement with and increase accessibility to between-session skills practice and treatment-related activities (e.g., self-monitoring, session summaries, worksheets). | Behavioural | Emotion Regulation Training via Telehealth |
Primary outcome
Changes in Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ)
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 30; maximum = 150; higher scores indicate worse outcomes)
Changes in Anxiety, Depression, and Distress: Depression Anxiety Stress Scale (DASS)
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 0-4 (minimum = 0; maximum = 84; higher scores indicate worse outcomes)
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 12; maximum = 60; higher scores indicate worse outcomes)
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 0-10 (minimum = 0; maximum = 30; higher scores indicate worse outcomes)
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-6 (minimum = 5; maximum = 30; higher scores indicate better outcomes)
Changes in Life Satisfaction: Patient-Reported Outcomes Measurement Information System (PROMIS): Meaning and Purpose
Time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up
Scale = 1-5 (minimum = 4; maximum = 20; higher scores indicate better outcomes)
10 secondary outcomes
Semi-Weekly Measures of Treatment Changes in Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS): Anxiety
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Depression: Patient-Reported Outcomes Measurement Information System (PROMIS): Depression
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Depression Symptoms
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Distress
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Worry: Brief Penn State Worry Questionnaire (PSWQ)
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Rumination: Brief Rumination-Reflection Questionnaire (RRQ)
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Emotion Regulation Questionnaire (ERQ)
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Metacognitive Regulation: Experiences Questionnaire (EQ)
Time frame: Semi-weekly over the course of four weeks
Semi-Weekly Measures of Treatment Changes in Attentional Regulation: The Attentional Control Scale (ACS)
Time frame: Semi-weekly over the course of four weeks
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
Time frame: Post-Treatment (4-5 weeks after starting treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Results publication: PubMed 29504794Mennin 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.
- Results publication: PubMed 29704969Renna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas S Mennin, Ph.D. principal investigator
Teachers College, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation Training via Telehealth in people with Distress, Emotional and Emotional Dysfunction, run by Teachers College, Columbia University 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 5 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 21 Nov 2024. 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 Anxiety, Depression, and Distress: Mood and Anxiety Symptoms Questionnaire (MASQ) (time frame: Pre-Treatment, Post-Treatment (4-5 weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up). The study lists 7 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 NCT04615416, which also lists 2 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 21 Nov 2024.