AzTrials
AzTrials

Major Depressive DisorderNCT05347719

Virtual Mindfulness Training for Adults With History of Depression

A study testing MBCT Intervention in people with Major Depressive Disorder, run by Clemson University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Major Depressive Disorder
What is being tested?
MBCT Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
1 Sep 2022to 1 Jun 2024
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Clemson University

    Clemson, South Carolina, 29634

  • Prisma Health

    Greenville, South Carolina, 29605

Other trials in United States

About this study

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.

Read the 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.

Being tested
MBCT Intervention
Keywords
Mindfulness Based Cognitive Therapy, Major Depressive Disorder, Virtual Delivery, Community Health
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBCT InterventionBehavioural

    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.

Study groups in NCT05347719
Study groupRoleWhat they receive
MBCT InterventionExperimentalEight weekly two-hour mindful MBCT intervention sessions led by a trained healthcare provider. Post-intervention, the experimental group will receive treatment as usual.
Receives: Behavioral: MBCT Intervention
Wait List ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  2. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  2. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  3. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  4. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  5. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  6. 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.

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

  7. 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).

    Measured: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2022
  2. Study start1 Sep 2022
  3. Primary completion31 May 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
To achieve our study aims, we designed a randomized, controlled trial with a treatment as usual (TAU) control group. A total of 240 eligible participants will be randomized to either an MBCT intervention group (Group 1) or an TAU control (Group 2). In Phase I, Group 1 will complete the intervention and Group 2 will remain in TAU. In Phase II , Group 2 will complete the intervention and Group 1 will continue TAU. Depending on the recruitment site, TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment within an academic medical center. Data collection will be completed at baseline, post-intervention for Group 1 and pre-intervention for Group 2, and after follow-up for Group 1 and post-intervention for Group 2. This design allows us to provide fair treatment for both trial arms as well as allowing for follow-up assessment of Group 1.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05347719
Sponsor's protocol ID
Pro00092709
Status last verified
Aug 2024
First submitted
14 Apr 2022
Last updated
20 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared outside the research team.

Publications

  • 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.

    PubMed 32878358

  • 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.

    PubMed 18310597

  • 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.

    PubMed 24009704

  • 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.

  • 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.

    PubMed 20204916

  • Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

    PubMed 6622612

  • 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.

    PubMed 21802700

  • 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. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23.

    PubMed 41522882

  • 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.

    PubMed 21916825

  • 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.

    PubMed 27492851

  • 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.

    PubMed 15939837

  • 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.

    PubMed 15049770

  • 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.

    PubMed 19911444

  • 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.

    PubMed 11556941

Questions about this trial

What is this clinical trial studying?

A study testing MBCT Intervention in people with Major Depressive Disorder, run by Clemson University at 2 sites 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 6 inclusion and 7 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change in Depression Severity (time frame: Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group)). The study lists 2 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 NCT05347719, which also lists 35 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 20 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in