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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Penn State University | OTHER |
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This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.
There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training | Active Comparator | Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation |
|
| Mindful Attention Only Training | Active Comparator | Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation |
|
| No Treatment Control Condition | No Intervention | No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience |
| Measure | Description | Time Frame |
|---|---|---|
| Daily life stress assessed via Ecological Momentary Assessment | change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily life state attention and acceptance assessed via Ecological Momentary Assessment | change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks | |
| Subjective stress in response to social evaluative threat | assessed at post-intervention, which is an average of 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily life affect assessed via Ecological Momentary Assessment | change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks | |
| Daily life social interactions assessed via Ecological Momentary Assessment | change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Weber, Ph.D. | National Center for Complementary and Integrative Health, National Institutes of Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carnegie Mellon University | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Pittsburgh Medical Center- Center for Integrative Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36656726 | Derived | Woods WC, Edershile EA, Ringwald WR, Sharpe BM, Himmelstein PH, Newman MG, Wilson SJ, Ellison WD, Levy KN, Pincus AL, Creswell JD, Wright AGC. Psychometric evaluation of a Visual Interpersonal Analog Scale. Psychol Assess. 2023 Apr;35(4):311-324. doi: 10.1037/pas0001210. Epub 2023 Jan 19. | |
| 32969686 | Derived | Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Mindfulness interventions improve momentary and trait measures of attentional control: Evidence from a randomized controlled trial. J Exp Psychol Gen. 2021 Apr;150(4):686-699. doi: 10.1037/xge0000969. Epub 2020 Sep 24. |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Salivary Cortisol in response to social evaluative threat | assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge |
| Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure) | assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session |
| Sustained attention measured by the Dichotic Listening Task | change from baseline to post-intervention, which is an average of 14 weeks |
| Sustained inattentional blindness measured by the Inattentional Blindness Task | post-intervention only |
| Perceived stress using the Perceived Stress Scale | change from baseline to post-intervention, which is an average of 14 weeks |
| Attentional control using the Attentional Control Scale | change from baseline to post-intervention, which is an average of 14 weeks |
| Treatment expectancies | post-intervention an average of 14 weeks after the baseline |
| Subjective responses to the training program intervention | composite of ratings made after each intervention lesson, an average of 10 weeks following baseline |
| Mindfulness using the Mindful Attention Awareness Scale | change from baseline to post-intervention, which is an average of 14 weeks |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| Pennsylvania State University | University Park | Pennsylvania | 16802 | United States |
| 31120272 | Derived | Chin B, Lindsay EK, Greco CM, Brown KW, Smyth JM, Wright AGC, Creswell JD. Psychological mechanisms driving stress resilience in mindfulness training: A randomized controlled trial. Health Psychol. 2019 Aug;38(8):759-768. doi: 10.1037/hea0000763. Epub 2019 May 23. |
| 30550321 | Derived | Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134. |