Brief Interventions for Coping With Distress

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Distress, Emotional focused on measuring Emotion Regulation, Distress Disorders, Anxiety, Depression, Worry, Rumination, Self-Criticism, Skills Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Teachers College, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Attention Skills Training

Attention and Reflective Thought Skills Training

Health and Wellness Education Training

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)

Changes in Ability to Regulate Attention: Attentional Control Scale (ACS)

Changes in Ability to Regulate Attention in Emotional Contexts: Emotional Attentional Control Scale (eACS)

Changes in Approach-Avoidance Motivation: Mental Representation of Approach Avoidance Questionnaire (MRAAQ)

Changes in Positive and Negative Emotions: Modified Differential Emotions Scale (mDES)

Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)

Secondary Outcome Measures

Changes in Mood and Anxiety Symptoms: Mood and Anxiety Symptoms Questionnaire (MASQ-90)

Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)

Changes in Worry: Penn State Worry Questionnaire (PSWQ)

Changes in Self-Criticism: Self-Judgement Subscale of the Self-Compassion Scale (SCS)

Changes in Functional Impairment: Sheehan Disability Scale (SDS)

Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)

Changes in Valued Living/Action: Valuing Questionnaire (VQ)

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

Full Information

NCT ID

NCT05779761

First Posted

March 9, 2023

Last Updated

April 18, 2023

Sponsor

Teachers College, Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT05779761

Brief Title

Brief Interventions for Coping With Distress

Official Title

A Randomized Controlled Trial of Brief Interventions for Coping With Distress

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2023 (Anticipated)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Teachers College, Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distress, Emotional, Emotional Dysfunction, Anxiety, Depression

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Attention Skills Training

Arm Type

Experimental

Arm Description

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.

Arm Title

Attention and Reflective Thought Skills Training

Arm Type

Experimental

Arm Description

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.

Arm Title

Health and Wellness Education Training

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Online, Self-Directed Attention Skills Training with Coaching Support

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame