Virtual Mindfulness Training for Adults With History of Depression

NCT05347719 | Completed

• 1 other identifier: Pro00092709
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Major Depressive Disorder

Keywords

Mindfulness Based Cognitive Therapy; Major Depressive Disorder; Virtual Delivery; Community Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Perceived 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

  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)

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

• Change in 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)

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

Other Outcomes (3)

• Change in 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

  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 over the course of 8 weeks for each intervention group cohort.

Study Arms (2)

MBCT Intervention

EXPERIMENTAL

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

Wait List Control

NO INTERVENTION

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.

Interventions

MBCT Intervention BEHAVIORAL

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.

MBCT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clemson University: lead
• Prisma Health-Upstate: collaborator

Study Sites (2)

Clemson University

Clemson, South Carolina, 29634, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

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MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Lu Shi, Ph.D.

  Clemson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 26, 2022
• Study Start: September 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: June 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)