Virtual Mindfulness Training for Adults With History of Depression

Mindfulness Based Cognitive Therapy (MBCT) has shown to be an effective method of preventing relapse of an episode Major Depressive Disorder (MDD). MBCT is a group program that integrates mindfulness skills training with cognitive-behavioral strategies. However, the cost of MBCT is not affordable to many families. The aim of this study is to explore the feasibility and efficacy of an MBCT intervention designed to be delivered at low cost through a virtual delivery format. This study will recruit 240 participants who are in remission from depression and randomize them to an MBCT intervention group or treatment as usual (TAU) for the wait list control group. The wait list control group will complete the intervention after the MBCT intervention group. Assessment administered at pre-intervention (baseline), post-intervention for experimental group, and post-intervention for the wait list control group and follow-up for experimental group. The primary outcome is to test the efficacy of this community-based delivery in reducing depression severity and psychiatric distress in the relapse of an episode of MDD. The secondary outcomes include perceived stress, post-traumatic stress symptoms, adherence to treatment plans not given as part of this study, frequency of relapse of MDD, mindfulness skills, and quality of life. This study will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBCT intervention adherence. Finally, the study will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: MBCT Intervention

Detailed Description

Mindfulness Based Cognitive Therapy (MBCT) has shown to be an effective method of preventing relapse of an episode Major Depressive Disorder (MDD). MBCT is a group program that integrates mindfulness skills training with cognitive-behavioral strategies. However, the cost of MBCT is not affordable to many families. The aim of this study is to explore the feasibility and efficacy of an MBCT intervention designed to be delivered at low cost through a virtual delivery format. The study will recruit 240 participants who are in remission from depression and randomize them to an MBCT intervention group or treatment as usual (TAU) for the wait list control group. The wait list control group will complete the intervention after the MBCT intervention group. Assessments will be administered at pre-intervention (baseline), post-intervention for experimental group (week 8), and post-intervention for the wait list control group and follow-up for experimental group (week 16). The primary outcome is to test the efficacy of this community-based delivery in reducing depression severity and psychiatric distress in the relapse of an episode of MDD. The secondary outcomes include perceived stress, post-traumatic stress symptoms, adherence to treatment plans not given as part of this study, frequency of relapse of MDD, mindfulness skills, and quality of life. This study will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBCT intervention adherence. Finally, this study will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Clemson, South Carolina, United States, 29634
      • Clemson University
    • Greenville, South Carolina, United States, 29605
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• be over 18 years of age
• be a resident of upstate South Carolina or Prisma Health beneficiary
• have a SCID confirmed diagnosis of a prior MDD episode
• be willing to share contact information
• have English literacy 6th grade or above
• be able to attend intervention sessions.

Exclusion Criteria:

• current psychosis, dementia, moderate to severe traumatic brain injury, or active suicidality
• persistent antisocial behavior
• persistent self-injury requiring clinical management
• an acute episode of a substance use disorder episode (met two or more SUD criteria in the past two weeks, excluding for tobacco or marijuana use)
• an acute episode of MDD (met two or more MDD criteria in the past two weeks)
• an active diagnosis of Bipolar Disorder
• previously completed or currently attending a standard MBCT intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBCT Intervention; Eight weekly two-hour mindful MBCT intervention sessions led by a trained healthcare provider. Post-intervention, the experimental group will receive treatment as usual.	Behavioral: MBCT Intervention; Eight weekly two-hour mindful MBCT intervention sessions involving training in mindfulness meditation and cognitive-behavioral methods. Sessions will be designed to increase participant awareness of internal reactions that trigger relapse in MDD and to provide participants with techniques to detach from dysfunctional cognitive processes and redirect their attention to experiences. Outside of the sessions, participants will be assigned daily homework exercises and provided with handouts and audio recordings of mindfulness exercises to use in their practice.
No Intervention: Wait List Control; Participants will engage in treatment as usual during the baseline period. After the experimental group completes the MBCT intervention, the wait list control group will complete the MBCT intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Severity	Depression severity will be assessed with the Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams 2001). PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe, and severe depression.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Psychiatric Distress	Psychiatric distress will be measured using the depression and anxiety subscales of the Brief Symptom Inventory (BSI; Derogatis & Melisaratos,1983). Items, such as "your feelings being easily hurt," are ranked on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Higher scores represent higher intensity of distress during the past week.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived stress	Perceived stress will be assessed with the Perceived Stress Scale-4 (Warting et al., 2013). The questions in this scale ask you about your feelings and thoughts related to stress during the last month, with 0 representing "seldom" and 4 representing "very often." Higher scores are correlated to more stress.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Posttraumatic stress	The PTSD CheckList - Civilian Version (PCL-C) will be used to assess PTSD symptoms (Ruggiero et al., 2003). The PCL is a self-report scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, with high scores characterize higher intensity of PTSD.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Adherence to Medication Assisted Treatment (MAT)	Adherence to other medical treatments not given as part of this study will be assessed with the Adherence to Refills and Medications Scale (ARMS; Kripalani et al., 2009). The ARMS scale is a 12 item scale that measures adherence to medications.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Mindfulness skills	FFMQ-15: 15-item Five-Facet Mindfulness Questionnaire https://www.sussexpartnership.nhs.uk/sites/default/files/documents/jenny_gus_short_ffmq-15_june_16.pdf. The FFMQ-15 measures 5 subscales of mindfulness: Observing, Describing, Acting with Awareness, Non-judgement, Non-reactivity; Scores range from 15 to 75, with higher scores indicating higher levels of mindfulness skills.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Perceived Quality of Life (health, well-being)	Quality of life will be assessed with the World Health Organization Quality of Life (WHOQOL-BREF; World Health Organization, 2004). The 26-item scale assesses quality of life, health, and other areas of wellbeing. Items are measured on a five-point scale. Higher scores represent higher quality of life.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Extent of mindfulness self-practice	Participants will be asked the following questions: "Besides the sessions you may have attended as part of this study, on your own, 'Did you engage in mindfulness meditation or other mindfulness practices in the past two months (8 weeks)?', 'How many days per week did you engage in mindfulness meditation or other mindfulness practices?', 'How long in minutes did you meditate per session of mindfulness meditation?', 'Describe your practice of mindfulness (what exercises/activities/techniques did you practice?).'" For quantitative analyses, we will use the variable representing number of days of mindfulness practice per week. We will also assess the number of sessions attended, number of non-completers, and reasons for dropout.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Frequency of major depressive disorder relapse episodes	The number of Major depressive relapse episodes will be identified using the ICD-10 codes for MDD in the DSM-5 (First, 2014).	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotion regulation	Emotion regulation will be assessed with the Difficulties in Emotion Regulation Scale-Short Form (Kaufman et al., 2016), an 18-item measure used to identify emotional regulation issues in adults. Higher values reflect greater difficulty with emotion regulation	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Change in Savoring	The Savoring Beliefs Inventory (Bryant, 2003) is a 24-item questionnaire consisting of three subscales: anticipating, savoring the moment, and reminiscing. Half of the items are positively formulated, while the other half are negatively framed. Each item is rated on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate higher levels of savoring.	Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)
Intervention fidelity	Intervention fidelity will be assessed with the Mindfulness-Based Relapse Prevention Adherence and Competence Scale (MBRP-AC; Chawla et al., 2010). All sessions will be audio recorded. Two members of the research team will rate 50% of a random selection of sessions using the MBRP-AC. Raters will code at least 10 practice sessions, which will be reviewed with the research team until acceptable reliability is achieved, and they will attend regular recalibration meetings to prevent drift. Group facilitators will also meet weekly with the licensed clinical psychologist, a member of the research team, for supervision.	Intervention fidelity will be assessed over the course of 8 weeks for each intervention group cohort.

Collaborators and Investigators

• Sponsor: Clemson University
• Collaborators: Prisma Health-Upstate
• Investigators: Principal Investigator: Lu Shi, Ph.D., Clemson University

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
• Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
• Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.
• Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added].
• Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
• Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
• Piet J, Hougaard E. The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Clin Psychol Rev. 2011 Aug;31(6):1032-40. doi: 10.1016/j.cpr.2011.05.002. Epub 2011 May 15.
• Chawla N, Collin S, Bowen S, Hsu S, Grow J, Douglass A, Marlatt GA. The mindfulness-based relapse prevention adherence and competence scale: development, interrater reliability, and validity. Psychother Res. 2010 Jul;20(4):388-97. doi: 10.1080/10503300903544257.
• Ames CS, Richardson J, Payne S, Smith P, Leigh E. Mindfulness-based cognitive therapy for depression in adolescents. Child Adolesc Ment Health. 2014 Feb;19(1):74-78. doi: 10.1111/camh.12034. Epub 2013 Aug 28.
• Batink T, Peeters F, Geschwind N, van Os J, Wichers M. How does MBCT for depression work? studying cognitive and affective mediation pathways. PLoS One. 2013 Aug 23;8(8):e72778. doi: 10.1371/journal.pone.0072778. eCollection 2013.
• Bryan F. Savoring Beliefs Inventory (SBI): A scale for measuring beliefs about savouring. Journal of Mental Health. 2003; 12(2):175-196.
• Căzănescu, DG, Tecuta, L, Cândea, DM, & Szentagotai-Tătar, A. Savoring as mediator between irrational beliefs, depression, and joy. Journal of Rational-Emotive & Cognitive-Behavior Therapy. 2019; 37(1): 84-95.
• Hanson HM, Salmoni AW. Stakeholders' perceptions of programme sustainability: findings from a community-based fall prevention programme. Public Health. 2011 Aug;125(8):525-32. doi: 10.1016/j.puhe.2011.03.003. Epub 2011 Jul 29.
• Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell, SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and replication in adolescent and adult samples. Journal of Psychopathology and Behavioral Assessment. 2016; 38(3), 443-455.
• IsHak WW, Greenberg JM, Balayan K, Kapitanski N, Jeffrey J, Fathy H, Fakhry H, Rapaport MH. Quality of life: the ultimate outcome measure of interventions in major depressive disorder. Harv Rev Psychiatry. 2011 Sep-Oct;19(5):229-39. doi: 10.3109/10673229.2011.614099.
• Joormann J, Stanton CH. Examining emotion regulation in depression: A review and future directions. Behav Res Ther. 2016 Nov;86:35-49. doi: 10.1016/j.brat.2016.07.007. Epub 2016 Jul 28.
• Kessing LV, Hansen MG, Andersen PK, Angst J. The predictive effect of episodes on the risk of recurrence in depressive and bipolar disorders - a life-long perspective. Acta Psychiatr Scand. 2004 May;109(5):339-44. doi: 10.1046/j.1600-0447.2003.00266.x.
• Kuyken W, Watkins E, Holden E, White K, Taylor RS, Byford S, Evans A, Radford S, Teasdale JD, Dalgleish T. How does mindfulness-based cognitive therapy work? Behav Res Ther. 2010 Nov;48(11):1105-12. doi: 10.1016/j.brat.2010.08.003. Epub 2010 Aug 13.
• Lengacher CA, Kip KE, Reich RR, Craig BM, Mogos M, Ramesar S, Paterson CL, Farias JR, Pracht E. A Cost-Effective Mindfulness Stress Reduction Program: A Randomized Control Trial for Breast Cancer Survivors. Nurs Econ. 2015 Jul-Aug;33(4):210-8, 232.
• Lorant V, Croux C, Weich S, Deliege D, Mackenbach J, Ansseau M. Depression and socio-economic risk factors: 7-year longitudinal population study. Br J Psychiatry. 2007 Apr;190:293-8. doi: 10.1192/bjp.bp.105.020040.
• MacKenzie MB, Kocovski NL. Mindfulness-based cognitive therapy for depression: trends and developments. Psychol Res Behav Manag. 2016 May 19;9:125-32. doi: 10.2147/PRBM.S63949. eCollection 2016.
• Mason O, Hargreaves I. A qualitative study of mindfulness-based cognitive therapy for depression. Br J Med Psychol. 2001 Jun;74(Pt 2):197-212.
• Michalak J, Holz A, Teismann T. Rumination as a predictor of relapse in mindfulness-based cognitive therapy for depression. Psychol Psychother. 2011 Jun;84(2):230-6. doi: 10.1348/147608310X520166. Epub 2011 Apr 13.
• Mueller TI, Leon AC, Keller MB, Solomon DA, Endicott J, Coryell W, Warshaw M, Maser JD. Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry. 1999 Jul;156(7):1000-6. doi: 10.1176/ajp.156.7.1000.
• Ruggiero KJ, Del Ben K, Scotti JR, Rabalais AE. Psychometric properties of the PTSD Checklist-Civilian Version. J Trauma Stress. 2003 Oct;16(5):495-502. doi: 10.1023/A:1025714729117.
• Segal ZV, Williams M, & Teasdale J. (2018). Mindfulness-based cognitive therapy for depression. Guilford Publications.
• Sharplin GR, Jones SB, Hancock B, Knott VE, Bowden JA, Whitford HS. Mindfulness-based cognitive therapy: an efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. Med J Aust. 2010 Sep 6;193(S5):S79-82. doi: 10.5694/j.1326-5377.2010.tb03934.x.
• Stirman SW, Miller CJ, Toder K, Calloway A. Development of a framework and coding system for modifications and adaptations of evidence-based interventions. Implement Sci. 2013 Jun 10;8:65. doi: 10.1186/1748-5908-8-65.
• Warttig SL, Forshaw MJ, South J, White AK. New, normative, English-sample data for the Short Form Perceived Stress Scale (PSS-4). J Health Psychol. 2013 Dec;18(12):1617-28. doi: 10.1177/1359105313508346. Epub 2013 Oct 22.
• World Health Organization. (2008). The global burden of disease: 2004 update. World Health Organization.
• World Health Organization. (2004). The world health organization quality of life (WHOQOL)- BREF (No. WHO/HIS/HSI Rev. 2012.02). World Health Organization.
• First, M. B. (2014). "Structured Clinical Interview for the DSM (SCID)." In The Encyclopedia of Clinical Psychology, edited by Robin L. Cautin and Scott O. Lilienfeld, 26:1-6. Hoboken, NJ, USA: John Wiley & Sons, Inc.
• Gross, J. J., & Thompson, R. A. (2006). Emotion regulation: Conceptual foundations. Handbook of emotion regulation.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; Virtual Delivery; Mindfulness Based Cognitive Therapy; Community Health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: Pro00092709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared outside the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No