CClinicalTrials.gg
RecruitingNCT05779761Updated Nov 21, 2024

Brief Interventions for Coping with Distress

An interventional study of Online, Self-Directed Attention Skills Training with Coaching Support and Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support in Distress, Emotional, Emotional Dysfunction and Anxiety, sponsored by Teachers College, Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Teachers College, Columbia University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Distress, Emotional
  • Emotional Dysfunction
  • Anxiety
  • Depression

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Keywords

  • Emotion Regulation
  • Distress Disorders
  • Anxiety
  • Depression
  • Worry
  • Rumination
  • Self-Criticism
  • Skills Training
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 180 is above the median of 84 across 6,720 interventional studies indexed under Depression.

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Lead sponsor

Teachers College, Columbia University is the lead sponsor of 26 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Attention Skills Training

    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.

    Behavioral: Online, Self-Directed Attention Skills Training with Coaching Support

  • Experimental
    Attention and Reflective Thought Skills Training

    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.

    Behavioral: Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support

  • Experimental
    Health and Wellness Education Training

    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.

    Behavioral: Online, Self-Directed Health & Wellness Education Training with Coaching Support

Interventions

  • BehavioralOnline, Self-Directed Attention Skills Training with Coaching Support

    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.

  • BehavioralOnline, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support

    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.

  • BehavioralOnline, Self-Directed Health & Wellness Education Training with Coaching Support

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)

    Time frame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)

    Time frame: Post-Training (6 weeks after starting the training)

07

Study locations

1 of 1 sites recruiting
  • Teachers College, Columbia University
    New York, New York 10027, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05779761
Lead sponsor
Teachers College, Columbia University
Responsible party
Douglas Mennin (Professor of Clinical Psychology, Teachers College, Columbia University) — Principal investigator
First posted
Mar 22, 2023
Start date
May 12, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 21, 2024

Study contacts

Douglas S Mennin, PhD
Contact
mennin@tc.columbia.edu
212-678-6609
Douglas S Mennin, PhD
principal investigator · Teachers College, Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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