Brief Interventions for Coping With Distress

Depression Clinical Trial

Official title:

A Randomized Controlled Trial of Brief Interventions for Coping With Distress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779761
• Other study ID #: 22-326
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Teachers College, Columbia University
• Contact: Douglas S Mennin, PhD
• Phone: 212-678-6609
• Email: mennin[@]tc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress, Emotional
• Emotional Dysfunction

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Teachers College, Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teachers College, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)		Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary	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
Secondary	Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)		Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary	Changes in Worry: Penn State Worry Questionnaire (PSWQ)		Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary	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
Secondary	Changes in Functional Impairment: Sheehan Disability Scale (SDS)		Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary	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
Secondary	Changes in Valued Living/Action: Valuing Questionnaire (VQ)		Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary	Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)		Post-Training (6 weeks after starting the training)