Brief Interventions for Coping with Distress

NCT ID: NCT05779761

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Distress, Emotional Emotional Dysfunction Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All participants will be randomly assigned to one of three skills trainings for coping with distress.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Online, Self-Directed Attention Skills Training with Coaching Support

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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Online, 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.

Intervention Type BEHAVIORAL

Online, 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.

Intervention Type BEHAVIORAL

Online, 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teachers College, Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Douglas Mennin

Professor of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas S Mennin, PhD

Role: PRINCIPAL_INVESTIGATOR

Teachers College, Columbia University

Locations

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Teachers College, Columbia University

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Douglas S Mennin, PhD

Role: CONTACT

212-678-6609

Facility Contacts

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Douglas S Mennin, PhD

Role: primary

212-678-6609

Douglas S Mennin, PhD

Role: backup

Other Identifiers

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22-326

Identifier Type: -

Identifier Source: org_study_id

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