Distress, EmotionalNCT05779761
Brief Interventions for Coping with Distress
A study testing Online, Self-Directed Attention Skills Training with Coaching Support, Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support and Online, Self-Directed Health & Wellness Education Training with Coaching Support 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 being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training. 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?
- Online, Self-Directed Attention Skills Training with Coaching Support, Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support and Online, Self-Directed Health & Wellness Education Training with Coaching Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 City
- Access to a smartphone and the internet
- 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
- Individuals currently receiving therapy or psychosocial treatment who do not plan to continue with the same treatment throughout the study period
- Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
- Current students at Teachers College, Columbia University
- Individuals with cardiac conditions, diagnosed hyperhidrosis, and traumatic brain injuries or other neurological conditions (e.g., dementia, Parkinson's, epilepsy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Teachers College, Columbia University
New York, New York, 10027
Douglas S Mennin, PhD, 212-678-6609, mennin@tc.columbia.edu
Douglas S Mennin, PhD
About this study
Official title: A Randomized Controlled Trial of Brief Interventions for Coping with Distress
This study is being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.
Read the detailed description
Adults living in New York City between the ages of 18-65 and experiencing elevated levels of worry, rumination, and/or self-criticism may be eligible to participate. After being informed about the study and potential risks, participants giving written informed consent will complete an online screening visit to determine full study eligibility. Eligible participant will then be randomized to complete 6-weeks of one of three self-directed, online skills training about coping with distress.
The present study is evaluating whether these skills trainings demonstrate efficacy in: 1) improving outcomes specific to an emotion regulation model of emotional distress (e.g., attentional control, decentering, reappraisal); 2) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination). Primary assessment points will take place before and after the skills training, and will include self-report measures, brief surveys during daily life, as well as computer tasks and measures of brain and body activity (e.g., EEG).
- Conditions
- Distress, Emotional, Emotional Dysfunction, Anxiety, Depression
- Being tested
- Online, Self-Directed Attention Skills Training with Coaching Support, Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support, Online, Self-Directed Health & Wellness Education Training with Coaching Support
- Keywords
- Emotion Regulation, Distress Disorders, Anxiety, Depression, Worry, Rumination, Self-Criticism, Skills Training
- Medical subject headings
- Anxiety Disorders, Depression, Emotional Regulation, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online, Self-Directed Attention Skills Training with Coaching SupportBehavioural
The initial set of modules focus on psychoeducation about distress, the impact that cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/rumination/self-criticism. The next set of modules focus on the development of attention skills that help 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). All modules will be online and self-directed. 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, worksheets). Brief, weekly coaching support (from a trained, masters-level student) will be provided to promote engagement and to help clarify concepts.
Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching SupportBehavioural
The initial set of modules focus on psychoeducation about distress, the impact that cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/rumination/self-criticism. The next set of modules focus on the development of attention and reflective thinking skills that help 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). All modules will be online and self-directed. 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, worksheets). Brief, weekly coaching support (from a trained, masters-level student) will be provided to promote engagement and to help clarify concepts.
Online, Self-Directed Health & Wellness Education Training with Coaching SupportBehavioural
The initial set of modules focus on psychoeducation about stress, the impact that stress has on one's life, and self-monitoring of stress. The next set of modules focus on sleep, time management, nutrition, and exercise. All modules will be online and self-directed. 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, worksheets). Brief, weekly coaching support (from a trained, masters-level student) will be provided to promote engagement and to help clarify concepts.
| Study group | Role | What they receive |
|---|---|---|
| Attention Skills Training | Experimental | Participants assigned to Attention Skills Training will receive 6-weeks of self-directed, online skills training on attention regulation skills for coping with distress. Six weekly modules will include 10-15 minutes of narrated videos, as well as suggestions for activities and skills practices between modules. Participants will also schedule weekly, 5-10 minute calls with an assigned skills training coach to discuss the participant's experience with the skills training. Receives: Behavioral: Online, Self-Directed Attention Skills Training with Coaching Support |
| Attention and Reflective Thought Skills Training | Experimental | Participants assigned to Attention and Reflective Thought Skills Training will receive 6-weeks of self-directed, online skills training on attention and metacognitive regulation skills for coping with distress. Six weekly modules will include 10-15 minutes of narrated videos, as well as suggestions for activities and skills practices between modules. Participants will also schedule weekly, 5-10 minute calls with an assigned skills training coach to discuss the participant's experience with the skills training. Receives: Behavioral: Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support |
| Health and Wellness Education Training | Experimental | Participants assigned to Health and Wellness Education Training will receive 6-weeks of self-directed, online skills training on stress-reduction psychoeducation. Six weekly modules will include 10-15 minutes of narrated videos, as well as suggestions for activities and skills practices between modules. Participants will also schedule weekly, 5-10 minute calls with an assigned skills training coach to discuss the participant's experience with the skills training. Receives: Behavioral: Online, Self-Directed Health & Wellness Education Training with Coaching Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ability to Regulate Emotions: Emotion Regulation Questionnaire (ERQ)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Ability to Regulate Attention: Attentional Control Scale (ACS)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Ability to Regulate Attention in Emotional Contexts: Emotional Attentional Control Scale (eACS)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Approach-Avoidance Motivation: Mental Representation of Approach Avoidance Questionnaire (MRAAQ)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Positive and Negative Emotions: Modified Differential Emotions Scale (mDES)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary outcomes (8)
Changes in Mood and Anxiety Symptoms: Mood and Anxiety Symptoms Questionnaire (MASQ-90)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Self-Criticism: Self-Judgement Subscale of the Self-Compassion Scale (SCS)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Valued Living/Action: Valuing Questionnaire (VQ)
Measured: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
Measured: Post-Training (6 weeks after starting the training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start12 May 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be randomly assigned to one of three skills trainings for coping with distress.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 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, PhD, Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779761
- Sponsor's protocol ID
- 22-326
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- A Randomized Controlled Trial of Brief Interventions for Coping with Distress
- ClinicalTrials.gov ID
- NCT05779761
- Acronym / sponsor ID
- 22-326
- Conditions
- Distress, Emotional, Emotional Dysfunction, Anxiety, Depression
- Keywords
- Emotion Regulation, Distress Disorders, Anxiety, Depression, Worry, Rumination, Self-Criticism, Skills Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Mar 2023 (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 being done to compare the effectiveness of three different skills trainings to cope with distress. These three trainings are: 1) an attention skills training, 2) an attention and reflective thought skills training, and 3) a health and wellness education training.
Detailed description
Adults living in New York City between the ages of 18-65 and experiencing elevated levels of worry, rumination, and/or self-criticism may be eligible to participate. After being informed about the study and potential risks, participants giving written informed consent will complete an online screening visit to determine full study eligibility. Eligible participant will then be randomized to complete 6-weeks of one of three self-directed, online skills training about coping with distress.
The present study is evaluating whether these skills trainings demonstrate efficacy in: 1) improving outcomes specific to an emotion regulation model of emotional distress (e.g., attentional control, decentering, reappraisal); 2) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination). Primary assessment points will take place before and after the skills training, and will include self-report measures, brief surveys during daily life, as well as computer tasks and measures of brain and body activity (e.g., EEG).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All participants will be randomly assigned to one of three skills trainings for coping with distress.
| Arm | Type | Receives |
|---|---|---|
| Attention Skills Training | Experimental | Behavioral: Online, Self-Directed Attention Skills Training with Coaching SupportParticipants assigned to Attention Skills Training will receive 6-weeks of self-directed, online skills training on attention regulation skills for coping with distress. Six weekly modules will include 10-15 minutes of narrated videos, as well as suggestions for activities and skills practices between modules. Participants will also schedule weekly, 5-10 minute calls with an assigned skills training coach to discuss the participant's experience with the skills training. |
| Attention and Reflective Thought Skills Training | Experimental | Behavioral: Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching SupportParticipants assigned to Attention and Reflective Thought Skills Training will receive 6-weeks of self-directed, online skills training on attention and metacognitive regulation skills for coping with distress. Six weekly modules will include 10-15 minutes of narrated videos, as well as suggestions for activities and skills practices between modules. Participants will also schedule weekly, 5-10 minute calls with an assigned skills training coach to discuss the participant's experience with the skills training. |
| Health and Wellness Education Training | Experimental | Behavioral: Online, Self-Directed Health & Wellness Education Training with Coaching SupportParticipants assigned to Health and Wellness Education Training will receive 6-weeks of self-directed, online skills training on stress-reduction psychoeducation. Six weekly modules will include 10-15 minutes of narrated videos, as well as suggestions for activities and skills practices between modules. Participants will also schedule weekly, 5-10 minute calls with an assigned skills training coach to discuss the participant's experience with the skills training. |
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 City
- Access to a smartphone and the internet
- High self-reported worry, rumination, and/or self-criticism
Key exclusion criteria (6 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
- Individuals currently receiving therapy or psychosocial treatment who do not plan to continue with the same treatment throughout the study period
- 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 |
|---|---|---|
| Online, Self-Directed Attention Skills Training with Coaching SupportThe initial set of modules focus on psychoeducation about distress, the impact that cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/rumination/self-criticism. The next set of modules focus on the development of attention skills that help 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). All modules will be online and self-directed. 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, worksheets). Brief, weekly coaching support (from a trained, masters-level student) will be provided to promote engagement and to help clarify concepts. | Behavioural | Attention Skills Training |
| Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching SupportThe initial set of modules focus on psychoeducation about distress, the impact that cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/rumination/self-criticism. The next set of modules focus on the development of attention and reflective thinking skills that help 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). All modules will be online and self-directed. 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, worksheets). Brief, weekly coaching support (from a trained, masters-level student) will be provided to promote engagement and to help clarify concepts. | Behavioural | Attention and Reflective Thought Skills Training |
| Online, Self-Directed Health & Wellness Education Training with Coaching SupportThe initial set of modules focus on psychoeducation about stress, the impact that stress has on one's life, and self-monitoring of stress. The next set of modules focus on sleep, time management, nutrition, and exercise. All modules will be online and self-directed. 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, worksheets). Brief, weekly coaching support (from a trained, masters-level student) will be provided to promote engagement and to help clarify concepts. | Behavioural | Health and Wellness Education Training |
Primary outcome
Changes in Ability to Regulate Emotions: Emotion Regulation Questionnaire (ERQ)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Ability to Regulate Attention: Attentional Control Scale (ACS)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Ability to Regulate Attention in Emotional Contexts: Emotional Attentional Control Scale (eACS)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Approach-Avoidance Motivation: Mental Representation of Approach Avoidance Questionnaire (MRAAQ)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Positive and Negative Emotions: Modified Differential Emotions Scale (mDES)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
8 secondary outcomes
Changes in Mood and Anxiety Symptoms: Mood and Anxiety Symptoms Questionnaire (MASQ-90)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Worry: Penn State Worry Questionnaire (PSWQ)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Self-Criticism: Self-Judgement Subscale of the Self-Compassion Scale (SCS)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Functional Impairment: Sheehan Disability Scale (SDS)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Changes in Valued Living/Action: Valuing Questionnaire (VQ)
Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
Time frame: Post-Training (6 weeks after starting the training)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
Douglas S Mennin, PhD 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 Online, Self-Directed Attention Skills Training with Coaching Support, Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support and Online, Self-Directed Health & Wellness Education Training with Coaching Support 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 6 inclusion and 6 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douglas S Mennin, PhD (212-678-6609, mennin@tc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Ability to Regulate Emotions: Emotion Regulation Questionnaire (ERQ) (time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month 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?
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.