[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05779761":3,"trial-entities:NCT05779761":132,"trial-summary:NCT05779761":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":14,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":53,"secondary_outcomes":69,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":107,"locations":110,"central_contacts":125,"overall_officials":127,"references":130,"see_also_links":131},"NCT05779761","22-326","Brief Interventions for Coping with Distress","A Randomized Controlled Trial of Brief Interventions for Coping with Distress","RECRUITING","2025-12","2024-11","2024-11-21","2023-05-12","Teachers College, Columbia University","OTHER",true,"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.","Adults living in New York City between the ages of 18-65 and experiencing elevated levels of worry, rumination, and\u002For 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.\n\nThe 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).",[19,20,21,22],"Distress, Emotional","Emotional Dysfunction","Anxiety","Depression",[24,25,21,22,26,27,28,29],"Emotion Regulation","Distress Disorders","Worry","Rumination","Self-Criticism","Skills Training","INTERVENTIONAL",[32],"NA",{"count":34,"type":35},180,"ESTIMATED",[37,43,48],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Online, Self-Directed Attention Skills Training with Coaching Support","The initial set of modules focus on psychoeducation about distress, the impact that cognitions\u002Fbehaviors\u002Femotions have on recent situations, and self-monitoring of worry\u002Frumination\u002Fself-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.",[42],"Attention Skills Training",{"type":38,"name":44,"description":45,"armGroupLabels":46},"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\u002Fbehaviors\u002Femotions have on recent situations, and self-monitoring of worry\u002Frumination\u002Fself-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.",[47],"Attention and Reflective Thought Skills Training",{"type":38,"name":49,"description":50,"armGroupLabels":51},"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.",[52],"Health and Wellness Education Training",[54,57,59,61,63,65,67],{"measure":55,"timeFrame":56},"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",{"measure":58,"timeFrame":56},"Changes in Ability to Distancing From Emotional Experience: Experiences Questionnaire (EQ)",{"measure":60,"timeFrame":56},"Changes in Ability to Regulate Attention: Attentional Control Scale (ACS)",{"measure":62,"timeFrame":56},"Changes in Ability to Regulate Attention in Emotional Contexts: Emotional Attentional Control Scale (eACS)",{"measure":64,"timeFrame":56},"Changes in Approach-Avoidance Motivation: Mental Representation of Approach Avoidance Questionnaire (MRAAQ)",{"measure":66,"timeFrame":56},"Changes in Positive and Negative Emotions: Modified Differential Emotions Scale (mDES)",{"measure":68,"timeFrame":56},"Change in Behavioral Dysregulation: Behavioral Dysregulation Scale (BDRS)",[70,72,74,76,78,80,82,84],{"measure":71,"timeFrame":56},"Changes in Mood and Anxiety Symptoms: Mood and Anxiety Symptoms Questionnaire (MASQ-90)",{"measure":73,"timeFrame":56},"Changes in Rumination: Rumination-Reflection Questionnaire (RRQ)",{"measure":75,"timeFrame":56},"Changes in Worry: Penn State Worry Questionnaire (PSWQ)",{"measure":77,"timeFrame":56},"Changes in Self-Criticism: Self-Judgement Subscale of the Self-Compassion Scale (SCS)",{"measure":79,"timeFrame":56},"Changes in Functional Impairment: Sheehan Disability Scale (SDS)",{"measure":81,"timeFrame":56},"Changes in Life Satisfaction: Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS)",{"measure":83,"timeFrame":56},"Changes in Valued Living\u002FAction: Valuing Questionnaire (VQ)",{"measure":85,"timeFrame":86},"Satisfaction and Usability of Treatment: Client Satisfaction Questionnaire (CSQ)","Post-Training (6 weeks after starting the training)","ALL","18 Years","65 Years",false,{"inclusion":92,"exclusion":99,"raw_text":106},[93,94,95,96,97,98],"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\u002For self-criticism","Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder",[100,101,102,103,104,105],"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)","Inclusion Criteria:\n\n* Between the ages of 18 and 65\n* Fluent in English (and therefore able to provide consent)\n* Currently living in New York City\n* Access to a smartphone and the internet\n* High self-reported worry, rumination, and\u002For self-criticism\n* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder\n\nExclusion Criteria:\n\n* Active suicidal ideation or intent\n* Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder\n* Individuals currently receiving therapy or psychosocial treatment who do not plan to continue with the same treatment throughout the study period\n* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months\n* Current students at Teachers College, Columbia University\n* Individuals with cardiac conditions, diagnosed hyperhidrosis, and traumatic brain injuries or other neurological conditions (e.g., dementia, Parkinson's, epilepsy)",[108,109],"ADULT","OLDER_ADULT",[111],{"facility":13,"status":8,"city":112,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":122},"New York","10027","United States",[116,121],{"name":117,"role":118,"phone":119,"email":120},"Douglas S Mennin, PhD","CONTACT","212-678-6609","mennin@tc.columbia.edu",{"name":117,"role":118},{"lat":123,"lon":124},40.71427,-74.00597,[126],{"name":117,"role":118,"phone":119,"email":120},[128],{"name":117,"affiliation":13,"role":129},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":133,"biomarkers":135},[21,22,134],"Stress",[],{"nct_id":4,"found":15,"summary":137,"prompt_version":146},{"design":138,"status":139,"heading":6,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is an interventional study comparing three different behavioral training programs. It plans to enroll 180 participants.","completed","This study is looking at three different online training programs to help people cope with distress, anxiety, and depression. These programs are: Online, Self-Directed Attention Skills Training with Coaching Support; Online, Self-Directed Attention & Reflective Thought Skills Training with Coaching Support; and Online, Self-Directed Health & Wellness Education Training with Coaching Support. Researchers want to see if these trainings can improve your ability to manage emotions, distance yourself from difficult emotional experiences, and control your attention. You might be able to join if you are between 18 and 65, live in New York City, speak English, have internet access, and experience high levels of worry, rumination (repetitive negative thoughts), or self-criticism. The study is planning to enroll 180 people, but its current status is unclear.","You will be followed for three months after completing the 6-week training program.",125,"You would complete an online screening, and if eligible, be randomly assigned to one of three 6-week online, self-directed skills trainings. You will complete assessments before, immediately after, and three months after the training.","Not stated in the trial record.",[39,44,49],"v2"]