Brief Interventions for Coping with Distress

NCT05779761 | Recruiting DMC

• 1 other identifier: 22-326
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distress, Emotional; Emotional Dysfunction; Anxiety; Depression

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Changes in Ability to Regulate Emotions: Emotion Regulation Questionnaire (ERQ)

  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)

  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)

  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)

  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)

  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)

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

• Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)

  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)

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

• Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)

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

• Changes in Worry: Penn State Worry Questionnaire (PSWQ)

  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)

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

• Changes in Functional Impairment: Sheehan Disability Scale (SDS)

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

Study Arms (3)

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.

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.

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.

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

Interventions

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

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

Attention and Reflective Thought Skills Training

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

Health and Wellness Education Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Emotional Regulation; Rumination Syndrome

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Study Officials

• Douglas S Mennin, PhD

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas S Mennin, PhD

CONTACT

212-678-6609; mennin@tc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Model Details: All participants will be randomly assigned to one of three skills trainings for coping with distress.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: May 12, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)