Brief Interventions for Coping With Distress

Sponsor

Teachers College, Columbia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05779761

Collaborator

(none)

180

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Distress, Emotional Emotional Dysfunction Anxiety Depression	Behavioral: Online, Self-Directed Attention Skills Training with Coaching Support Behavioral: Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support Behavioral: Online, Self-Directed Health & Wellness Education Training with Coaching Support	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

A Randomized Controlled Trial of Brief Interventions for Coping With Distress

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 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.
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 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.
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 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.

Arm

Intervention/Treatment

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

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.

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

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.

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

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) [Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up]
Changes in Valued Living/Action: Valuing Questionnaire (VQ) [Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up]
Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ) [Post-Training (6 weeks after starting the training)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)