RuminationNCT05590741
An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy
A study testing Emotion Regulation Therapy via Telehealth in people with Rumination and Worry, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
This study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rumination, Worry, Self-Criticism
- What is being tested?
- Emotion Regulation Therapy via Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to Nov 2025
- 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
- Between the ages of 18 and 65
- Fluent in English (and therefore able to provide consent)
- Currently living in New York State
- Access to at least one device with internet and video-conferencing capabilities
- High self-reported worry, rumination, and/or self-criticism
- Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder
Who cannot join
- Active suicidal ideation or intent
- Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
- Currently in therapy or receiving any type of psychosocial treatment
- Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
- Current students at Teachers College, Columbia University
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: An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy: A Multiple Case-Based Design
This study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.
Read the detailed description
The main questions this study aims to answer are to:
- Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.
- Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.
- Demonstrate the preliminary efficacy of a 12-session version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.
Participants will:
- Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare
- Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College
- Attend 12 once-weekly telehealth ERT sessions
- Complete 18 weekly questionnaires online via Qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).
- Conditions
- Rumination, Worry, Self-Criticism, Anxiety, Depression, Distress, Emotional
- Being tested
- Emotion Regulation Therapy via Telehealth
- Keywords
- Worry, Rumination, Self-Criticism, Emotion Regulation Therapy, Emotion Regulation, Treatment Mechanisms
- Medical subject headings
- Rumination Syndrome, Anxiety Disorders, Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation Therapy 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 |
|---|---|---|
| Treatment | Experimental | All participants will receive a 12-session version of Emotion Regulation Therapy delivered weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based online platform to supplement the content covered in each session. Receives: Behavioral: Emotion Regulation Therapy via Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Assessment of Change in Attentional Control
The Attentional Control Scale (ACS) is a 21-item measure used to measure difficulties with concentration associated with problems regulating emotions. The focusing and shifting subscales of the ACS align with the two attention emotion regulation (ER) skills taught in ERT.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Decentering
The decentering subscale of the Experiences Questionnaire (EQ-D) is an 11-item subscale assessing one's ability to distance themselves from their emotional experience, which is one metacognitive ER skill taught during ERT. Higher scores on this subscale indicate better ability to distancing oneself from one's emotional experience.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Reappraisal
The reappraisal subscale of the Emotion Regulation Questionnaire (ERQ) is a 6-item measure of the ability to regulate emotions, using the strategy of reappraisal. Higher scores on this subscale indicate a better ability to regulate emotions using the strategy of reappraisal.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Valued Living/Action
The Valuing Questionnaire (VQ) is a 10-item measure of the degree to which patients live by their values in daily life. It uses a 7-point Likert scale (0-6) to assess progress and obstructions to valued living. Higher scores on this measure indicate more valued living.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation
The Mental Representation of Approach Avoidance Questionnaire (MRAAQ) is a 42-item self-report assessment designed to capture the mental representation of approach-avoidance motivation.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Secondary outcomes (5)
Weekly Assessment of Change in Depression Severity
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Emotional Distress - Depression - Short Form 8a will be administered to assess for depression severity. Higher scores on this measure indicate greater depression severity.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Anxiety Severity
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank - Emotional Distress - Anxiety - Short Form 8a will be administered to assess for anxiety severity. Higher scores on this measure indicate greater anxiety severity.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Rumination
The Rumination-Reflection Questionnaire (RRQ) is a 12-item measure that assesses past-focused rumination with specificity regarding the types of rumination that people may experience. Higher scores on this measure indicate greater rumination.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Worry
The Penn State Worry Questionnaire - Past Week (PSWQ-PW) is an adapted version of the original PSWQ, contains 15 items (rated on a 0-6 scale), and assesses the extent to which worry has been excessive, uncontrollable, and pervasive in the past week. Higher scores on this measure indicate greater worry in the past week.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Self-Criticism
The self-judgment subscale of the Self-Compassion Scale (SCS) contains 5-items and assesses the tendency to self-criticize. Higher scores on this measure indicate greater self-criticism.
Measured: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start16 Nov 2022
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RuminationStudies 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Mennin, Teachers College, Columbia University
- Investigators
- Douglas S Mennin, Principal investigator, Professor of Clinical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590741
- Sponsor's protocol ID
- 23-008
- Status last verified
- Jun 2024
- First submitted
- 13 Oct 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy: A Multiple Case-Based Design
- ClinicalTrials.gov ID
- NCT05590741
- Acronym / sponsor ID
- 23-008
- Conditions
- Rumination, Worry, Self-Criticism, Anxiety, Depression, Distress, Emotional
- Keywords
- Worry, Rumination, Self-Criticism, Emotion Regulation Therapy, Emotion Regulation, Treatment Mechanisms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 21 Oct 2022 (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 to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.
Detailed description
The main questions this study aims to answer are to:
- Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.
- Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.
- Demonstrate the preliminary efficacy of a 12-session version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.
Participants will:
- Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare
- Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College
- Attend 12 once-weekly telehealth ERT sessions
- Complete 18 weekly questionnaires online via Qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Emotion Regulation Therapy via TelehealthAll participants will receive a 12-session version of Emotion Regulation Therapy delivered weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based online platform to supplement the content covered in each session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 18 and 65
- Fluent in English (and therefore able to provide consent)
- Currently living in New York State
- Access to at least one device with internet and video-conferencing capabilities
- High self-reported worry, rumination, and/or self-criticism
Key exclusion criteria (5 listed)
- Active suicidal ideation or intent
- Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
- Currently in therapy or receiving any type of psychosocial treatment
- Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
- Current students at Teachers College, Columbia University
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 Therapy 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 | Treatment |
Primary outcome
Weekly Assessment of Change in Attentional Control
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
The Attentional Control Scale (ACS) is a 21-item measure used to measure difficulties with concentration associated with problems regulating emotions. The focusing and shifting subscales of the ACS align with the two attention emotion regulation (ER) skills taught in ERT.
Weekly Assessment of Change in Decentering
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
The decentering subscale of the Experiences Questionnaire (EQ-D) is an 11-item subscale assessing one's ability to distance themselves from their emotional experience, which is one metacognitive ER skill taught during ERT. Higher scores on this subscale indicate better ability to distancing oneself from one's emotional experience.
Weekly Assessment of Change in Reappraisal
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
The reappraisal subscale of the Emotion Regulation Questionnaire (ERQ) is a 6-item measure of the ability to regulate emotions, using the strategy of reappraisal. Higher scores on this subscale indicate a better ability to regulate emotions using the strategy of reappraisal.
Weekly Assessment of Change in Valued Living/Action
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
The Valuing Questionnaire (VQ) is a 10-item measure of the degree to which patients live by their values in daily life. It uses a 7-point Likert scale (0-6) to assess progress and obstructions to valued living. Higher scores on this measure indicate more valued living.
Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
The Mental Representation of Approach Avoidance Questionnaire (MRAAQ) is a 42-item self-report assessment designed to capture the mental representation of approach-avoidance motivation.
5 secondary outcomes
Weekly Assessment of Change in Depression Severity
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Anxiety Severity
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Rumination
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Worry
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Weekly Assessment of Change in Self-Criticism
Time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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 principal investigator
Professor of Clinical Psychology
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 Therapy via Telehealth in people with Rumination and Worry, 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 6 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: status not confirmed, as of the sponsor's last update on 4 Jun 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?
Results are not available in the source record.
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?
Weekly Assessment of Change in Attentional Control (time frame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)). 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?
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 4 Jun 2024.