Major Depressive Disorder
Conditions
Keywords
Mindfulness Based Cognitive Therapy, Major Depressive Disorder, Virtual Delivery, Community Health
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.
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.
Interventions
BEHAVIORALMBCT 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.
Sponsors
Prisma Health-Upstate
Clemson University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Severity | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
| Change in Psychiatric Distress | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Posttraumatic stress | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
| 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) | 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. |
| Change in Mindfulness skills | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
| Change in Perceived stress | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
| 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) | 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. |
| Change in Extent of mindfulness self-practice | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
| Change in Frequency of major depressive disorder relapse episodes | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | The number of Major depressive relapse episodes will be identified using the ICD-10 codes for MDD in the DSM-5 (First, 2014). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotion regulation | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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 |
| Change in Savoring | Baseline, 8 weeks (post-intervention for experimental group), 16 weeks (follow-up for experimental group, post-intervention for control group) | 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. |
| Intervention fidelity | Intervention fidelity will be assessed over the course of 8 weeks for each intervention group cohort. | 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. |
Countries
United States
Outcome results
None listed