Mental HealthNCT03336710
Perspective on Thoughts and Feelings as a Predictor of Psychological Well-being in Daily Life, in a Community Sample
An observational study of Mental Health and Mindfulness, run by State University of New York at Buffalo at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Mindfulness
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 17 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population from which the sample will be recruited will be residents of the greater Buffalo, NY metropolitan area.
Who may be able to join
- age 18-65, fluency in English
Who cannot join
- current cognitive impairments (i.e., intellectual disability, dementia, current psychotic symptoms) that preclude giving informed consent and accurately answering study questions
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo, Department of psychology
Buffalo, New York, 14260
About this study
Official title: Decentering in Daily Life: Underlying Mechanisms and Impact on Well-Being
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).
Read more
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:
- 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
- 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.
- Conditions
- Mental Health, Mindfulness
- Keywords
- Self-control, Ecological Momentary Assessment, Attentional bias, Respiratory Sinus Arrhythmia, Affect, Emotion Regulation, Well-being, Decentering, Affective disorders
- Medical subject headings
- Psychological Well-Being, Self-Control, Arrhythmia, Sinus, Emotional Regulation, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary sample | Community sample of adults (18-65) from the greater Buffalo, NY region, oversampling people who are seeking mental health treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 x daily for 7 days following the baseline assessment
Momentary eudaimonic well-being
2 items assessing eudaimonic well-being adapted from Breines et al. (2008) and Lambert et al. (2013)
Measured: 6 x daily for 7 days following the baseline assessment
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).
Measured: 6 x daily for 7 days following the baseline assessment
State Decentering
4 items assessing current decentering, adapted from Fresco et al. (2007), Gillanders et al. (2014), and Shoham et al. (2017)
Measured: 6 x daily for 7 days following the baseline assessment
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)
Measured: Baseline session only
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.
Measured: Baseline session only
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).
Measured: Baseline session only
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).
Measured: Baseline session only
Secondary outcomes (9)
Self-reported momentary self-regulation
3 questions assessing current perceived willpower \& mental exhaustion, adapted from Davisson (2013) and Milyavskaya \& Inzlicht (2017).
Measured: 6 x daily for 7 days following the baseline assessment
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)
Measured: 6 x daily for 7 days following the baseline assessment
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.
Measured: Baseline session only
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.
Measured: Baseline session only
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).
Measured: Baseline session only
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
Measured: Baseline session only
Baseline attentional breadth: Thought Control Questionnaire
Self-report measure corresponding to various emotion regulation strategies (distraction and reappriasal)
Measured: Baseline session only
Baseline attentional breadth: Responses to Positive Affect Scale
Self-report measure corresponding to various emotion regulation strategies (positive rumination)
Measured: Baseline session only
Baseline attentional breadth: Ruminative Responses Scale
Self-report measure corresponding to various emotion regulation strategies (negative rumination)
Measured: Baseline session only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start6 Jul 2017
- Primary completion7 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Kenneth G. DeMarree, State University of New York at Buffalo
- Investigators
- Kristin Gainey, Ph.D., Principal investigator, University at BuffaloKenneth G DeMarree, Ph.D., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336710
- Sponsor's protocol ID
- 1R21AT009470-01
- Other IDs
- R21AT009470
- Status last verified
- Jul 2019
- First submitted
- 25 Oct 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Publications
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.
PubMed 27797554Bernstein 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.
PubMed 26385999Shoham 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.
PubMed 28134540Naragon-Gainey K, DeMarree KG. Decentering attentuates the associations of negative affect and positive affect with psychopathology. Clinical Psychological Science. Epub 2017 Aug 11.
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. doi: 10.1111/j.0022-3506.2004.00263.x.
PubMed 15016066Fresco 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. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.
PubMed 17697849Gillanders 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.
PubMed 24411117Watson 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. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Watson 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. doi: 10.1037/1040-3590.19.3.253.
PubMed 17845118Gross 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. doi: 10.1037/0022-3514.85.2.348.
PubMed 12916575
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decentering in Daily Life: Underlying Mechanisms and Impact on Well-Being
- ClinicalTrials.gov ID
- NCT03336710
- Acronym / sponsor ID
- 1R21AT009470-01
- Conditions
- Mental Health, Mindfulness
- Keywords
- Self-control, Ecological Momentary Assessment, Attentional bias, Respiratory Sinus Arrhythmia, Affect, Emotion Regulation, Well-being, Decentering
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary sample | – | –Community sample of adults (18-65) from the greater Buffalo, NY region, oversampling people who are seeking mental health treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population from which the sample will be recruited will be residents of the greater Buffalo, NY metropolitan area.
Key inclusion criteria (1 listed)
- age 18-65, fluency in English
Key exclusion criteria (1 listed)
- current cognitive impairments (i.e., intellectual disability, dementia, current psychotic symptoms) that preclude giving informed consent and accurately answering study questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Momentary psychological distress
Time frame: 6 x daily for 7 days following the baseline assessment
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)
Momentary eudaimonic well-being
Time frame: 6 x daily for 7 days following the baseline assessment
2 items assessing eudaimonic well-being adapted from Breines et al. (2008) and Lambert et al. (2013)
Momentary hedonic well-being (state positive and negative affect)
Time frame: 6 x daily for 7 days following the baseline assessment
8 items assessing hedonic well-being (positive and negative affect), taken from the Positive and Negative Affect Schedule (PANAS).
State Decentering
Time frame: 6 x daily for 7 days following the baseline assessment
4 items assessing current decentering, adapted from Fresco et al. (2007), Gillanders et al. (2014), and Shoham et al. (2017)
Trait Decentering: Experiences Questionnaire
Time frame: Baseline session only
Experiences Questionnaire is a trait measure of decentering, which assesses the Observer Perspective aspect of decentering. From Fresco et al., (2007)
Trait decentering: Valence free decentering measure
Time frame: Baseline session only
This is an in-development measure of decentering that measures the construct of decentering without explicitly referring to negative thoughts and feelings.
Trait decentering: Cognitive Fusion Questionnaire
Time frame: Baseline session only
The Cognitive Fusion Questionnaire is a decentering measure that assesses the Reduced Struggle with Inner Experiences aspect of decentering. From Gillanders et al., (2014).
Trait decentering: Toronto Mindfulness Scale-Decentering Subscale
Time frame: Baseline session only
The Toronto Mindfulness Scale-Decentering subscale is a decentering measure that assesses the Observer Perspective aspect of decentering. From Davis, Lau, \& Cairns (2009).
9 secondary outcomes
Self-reported momentary self-regulation
Time frame: 6 x daily for 7 days following the baseline assessment
Self-reported momentary attentional focus
Time frame: 6 x daily for 7 days following the baseline assessment
Baseline self-regulation: Go/no-go task
Time frame: Baseline session only
Baseline self-regulation: Resting heart rate variability
Time frame: Baseline session only
Baseline self-regulation: Self-Control Scale (short form)
Time frame: Baseline session only
Baseline attentional breadth: Emotional eye-tracking paradigm
Time frame: Baseline session only
Baseline attentional breadth: Thought Control Questionnaire
Time frame: Baseline session only
Baseline attentional breadth: Responses to Positive Affect Scale
Time frame: Baseline session only
Baseline attentional breadth: Ruminative Responses Scale
Time frame: Baseline session only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 27797554Naragon-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.
- Background: PubMed 26385999Bernstein 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.
- Background: PubMed 28134540Shoham 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.
- BackgroundNaragon-Gainey K, DeMarree KG. Decentering attentuates the associations of negative affect and positive affect with psychopathology. Clinical Psychological Science. Epub 2017 Aug 11.
- Background: PubMed 15016066Tangney 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. doi: 10.1111/j.0022-3506.2004.00263.x.
- Background: PubMed 17697849Fresco 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. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.
- Background: PubMed 24411117Gillanders 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.
- Background: PubMed 3397865Watson 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. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 17845118Watson 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. doi: 10.1037/1040-3590.19.3.253.
- Background: PubMed 12916575Gross 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. doi: 10.1037/0022-3514.85.2.348.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Gainey, Ph.D. principal investigator
University at Buffalo
Kenneth G DeMarree, Ph.D. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Mindfulness, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Momentary psychological distress (time frame: 6 x daily for 7 days following the baseline assessment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336710, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.