Clinical trial NCT05779761: Brief Interventions for Coping with Distress
Official title: A Randomized Controlled Trial of Brief Interventions for Coping with Distress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distress, Emotional
Emotional Dysfunction
Anxiety
Depression
Keywords: Emotion Regulation
Distress Disorders
Anxiety
Depression
Worry
Rumination
Self-Criticism
Skills Training
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be randomly assigned to one of three skills trainings for coping with distress.
Primary purpose: OTHER

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in Ability to Regulate Emotions: Emotion Regulation Questionnaire (ERQ)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Ability to Regulate Attention: Attentional Control Scale (ACS)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Ability to Regulate Attention in Emotional Contexts: Emotional Attentional Control Scale (eACS)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Approach-Avoidance Motivation: Mental Representation of Approach Avoidance Questionnaire (MRAAQ)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Positive and Negative Emotions: Modified Differential Emotions Scale (mDES)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
Secondary outcomes:
measure: Changes in Mood and Anxiety Symptoms: Mood and Anxiety Symptoms Questionnaire (MASQ-90)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Worry: Penn State Worry Questionnaire (PSWQ)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Self-Criticism: Self-Judgement Subscale of the Self-Compassion Scale (SCS)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Functional Impairment: Sheehan Disability Scale (SDS)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Changes in Valued Living/Action: Valuing Questionnaire (VQ)
timeFrame: Pre-Training, Post-Training (6 weeks after starting the training), and 3-Month Follow-Up
measure: Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-Training (6 weeks after starting the training)
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College, Columbia University
name: Douglas S Mennin, PhD
role: PRINCIPAL_INVESTIGATOR
References: