Virtual Mindfulness Training for Adults With History of Depression

Major Depressive Disorder Clinical Trial

Official title:

Virtual Mindfulness Training for Adults With History of Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05347719
• Other study ID #: Pro00092709
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Clemson University
• Contact: Lu Shi, Ph.D.
• Phone: 864-656-0495
• Email: lus[@]clemson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Clemson University	Clemson	South Carolina
United States	Prisma Health	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Clemson University	Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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.
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)