Clinical trial NCT05590741: An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy
Official title: An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy: A Multiple Case-Based Design
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rumination
Worry
Self-Criticism
Anxiety
Depression
Distress, Emotional
Keywords: Worry
Rumination
Self-Criticism
Emotion Regulation Therapy
Emotion Regulation
Treatment Mechanisms
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.

Detailed description: The main questions this study aims to answer are to:

1. Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.
2. Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.
3. Demonstrate the preliminary efficacy of a 12-session version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.

Participants will:

1. Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare
2. Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College
3. Attend 12 once-weekly telehealth ERT sessions
4. Complete 18 weekly questionnaires online via Qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).

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 State
* Access to at least one device with internet and video-conferencing capabilities
* 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
* Currently in therapy or receiving any type of psychosocial treatment
* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
* Current students at Teachers College, Columbia University

Primary outcomes:
measure: Weekly Assessment of Change in Attentional Control
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Decentering
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Reappraisal
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Valued Living/Action
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Secondary outcomes:
measure: Weekly Assessment of Change in Depression Severity
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Anxiety Severity
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Rumination
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Worry
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Self-Criticism
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Other outcomes:
measure: Weekly Assessment of Change in Disability/Impairment
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Life Satisfaction
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
measure: Weekly Assessment of Change in Behavioral Regulation
timeFrame: Weekly from Baseline (2 weeks) through Treatment (12 weeks) and Follow-Up (4 weeks)
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Professor of Clinical Psychology
name: Douglas S Mennin
role: PRINCIPAL_INVESTIGATOR
References: