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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03336710
Other study ID # 1R21AT009470-01
Secondary ID R21AT009470
Status Completed
Phase
First received
Last updated
Start date July 6, 2017
Est. completion date December 17, 2018

Study information

Verified date July 2019
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project examines the psychological construct of decentering - a mindfulness-related construct marked by an observer perspective on one's ongoing mental processes. Specifically, this project seeks to explore the extent to which decentering modulates the relationship between people's affective states and their momentary mental health and well-being, and to test the psychological processes by which decentering might exert these effects. This study includes a baseline assessment followed by a 7-day study completed from home where participants respond to brief surveys about their current experiences six times per day (i.e., an Ecological Momentary Assessment [EMA] design).

The investigators hypothesize that decentering moderates the association of extreme affect with related symptoms (i.e., elevated negative affect with depression and anxiety; elevated positive affect with mania, narcissism, and histrionic traits) and well-being, such that the association is attenuated at high levels of decentering. This will be examined using the EMA data, analyzing between-person levels (i.e., trait) as well as momentary within-person processes (i.e., concurrent and prospective states).

Further, the investigators predict that broadened attentional focus and improved self-regulation are mechanisms that contribute to the beneficial effects of decentering in daily life. This hypothesis will be examined in two ways:

1. as individual differences, wherein greater self-regulatory abilities (e.g., higher heart rate variability) and less attentional biases towards emotional stimuli mediate the association between trait decentering and subsequent daily well-being/symptoms, and

2. as within-person momentary levels, wherein broader attentional processes and greater self-regulation in daily life mediate the concurrent and prospective association between momentary decentering and well-being/symptoms.

Note that the study uses a multimodal assessment of each of the proposed processes. For attentional processes, a variety of parameters extracted from an emotional eye tracking paradigm will be examined. For self-regulatory abilities, assessments will include self-report, physiological (heart rate variability), and behavioral ("go / no-go" task) measures of such abilities.


Recruitment information / eligibility

Status Completed
Enrollment 380
Est. completion date December 17, 2018
Est. primary completion date December 7, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- age 18-65, fluency in English

Exclusion Criteria:

- current cognitive impairments (i.e., intellectual disability, dementia, current psychotic symptoms) that preclude giving informed consent and accurately answering study questions

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University at Buffalo, Department of psychology Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
State University of New York at Buffalo National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bernstein A, Hadash Y, Lichtash Y, Tanay G, Shepherd K, Fresco DM. Decentering and Related Constructs: A Critical Review and Metacognitive Processes Model. Perspect Psychol Sci. 2015 Sep;10(5):599-617. doi: 10.1177/1745691615594577. Review. — View Citation

Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. Epub 2007 Apr 24. — View Citation

Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18. — View Citation

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. — View Citation

Naragon-Gainey K, DeMarree KG. Decentering attentuates the associations of negative affect and positive affect with psychopathology. Clinical Psychological Science. Epub 2017 Aug 11.

Naragon-Gainey K, DeMarree KG. Structure and validity of measures of decentering and defusion. Psychol Assess. 2017 Jul;29(7):935-954. doi: 10.1037/pas0000405. Epub 2016 Oct 31. — View Citation

Shoham A, Goldstein P, Oren R, Spivak D, Bernstein A. Decentering in the process of cultivating mindfulness: An experience-sampling study in time and context. J Consult Clin Psychol. 2017 Feb;85(2):123-134. doi: 10.1037/ccp0000154. — View Citation

Tangney JP, Baumeister RF, Boone AL. High self-control predicts good adjustment, less pathology, better grades, and interpersonal success. J Pers. 2004 Apr;72(2):271-324. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. — View Citation

Watson D, O'Hara MW, Simms LJ, Kotov R, Chmielewski M, McDade-Montez EA, Gamez W, Stuart S. Development and validation of the Inventory of Depression and Anxiety Symptoms (IDAS). Psychol Assess. 2007 Sep;19(3):253-68. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Momentary psychological distress 2 items (developed new for this study) assessing the presence and impact of idiographic symptoms identified at baseline, and 4 items assessing dysphoria adapted from the Inventory of Depression and Anxiety Symptoms (IDAS) 6 x daily for 7 days following the baseline assessment
Primary Momentary eudaimonic well-being 2 items assessing eudaimonic well-being adapted from Breines et al. (2008) and Lambert et al. (2013) 6 x daily for 7 days following the baseline assessment
Primary Momentary hedonic well-being (state positive and negative affect) 8 items assessing hedonic well-being (positive and negative affect), taken from the Positive and Negative Affect Schedule (PANAS). 6 x daily for 7 days following the baseline assessment
Primary State Decentering 4 items assessing current decentering, adapted from Fresco et al. (2007), Gillanders et al. (2014), and Shoham et al. (2017) 6 x daily for 7 days following the baseline assessment
Primary Trait Decentering: Experiences Questionnaire Experiences Questionnaire is a trait measure of decentering, which assesses the Observer Perspective aspect of decentering. From Fresco et al., (2007) Baseline session only
Primary Trait decentering: Valence free decentering measure This is an in-development measure of decentering that measures the construct of decentering without explicitly referring to negative thoughts and feelings. Baseline session only
Primary Trait decentering: Cognitive Fusion Questionnaire The Cognitive Fusion Questionnaire is a decentering measure that assesses the Reduced Struggle with Inner Experiences aspect of decentering. From Gillanders et al., (2014). Baseline session only
Primary Trait decentering: Toronto Mindfulness Scale-Decentering Subscale The Toronto Mindfulness Scale-Decentering subscale is a decentering measure that assesses the Observer Perspective aspect of decentering. From Davis, Lau, & Cairns (2009). Baseline session only
Secondary Self-reported momentary self-regulation 3 questions assessing current perceived willpower & mental exhaustion, adapted from Davisson (2013) and Milyavskaya & Inzlicht (2017). 6 x daily for 7 days following the baseline assessment
Secondary Self-reported momentary attentional focus 4 attentional emotion regulation items (distraction, positive rumination, negative rumination, and reappraisal) adapted from Brans et al. (2013), Feldman et al. (2008), and Nolen-Hoeksema & Morrow (1991) 6 x daily for 7 days following the baseline assessment
Secondary Baseline self-regulation: Go/no-go task Go/no-go task asks people to respond to a large number of "go" trials (80%) and a smaller number of "no go" trials. The ability to inhibit the dominant "go" response is seen as an operative measure of self-regulatory abilities, consequently the number of "no go" signals responded to is one measure of self-regulatory abilities. Baseline session only
Secondary Baseline self-regulation: Resting heart rate variability Assessed with a Polar V800 athletic watch during a 5-minute vanilla baseline and a 5-minute paced breathing task. Baseline session only
Secondary Baseline self-regulation: Self-Control Scale (short form) A self-report measure of people's perceived self-control abilities and outcomes, developed by Tangney, Baumeister, & Boone (2004). Baseline session only
Secondary Baseline attentional breadth: Emotional eye-tracking paradigm Participants will view a series of emotionally expressive versus neutral faces, and the fixation time and number of fixations towards emotionally evocative (angry, sad, happy) faces will serve as indicators of attentional bias Baseline session only
Secondary Baseline attentional breadth: Thought Control Questionnaire Self-report measure corresponding to various emotion regulation strategies (distraction and reappriasal) Baseline session only
Secondary Baseline attentional breadth: Responses to Positive Affect Scale Self-report measure corresponding to various emotion regulation strategies (positive rumination) Baseline session only
Secondary Baseline attentional breadth: Ruminative Responses Scale Self-report measure corresponding to various emotion regulation strategies (negative rumination) Baseline session only
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