Online Mindfulness-Based Cognitive Therapy in Depressed Sample

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the effectiveness of the online 6-weeks Mindfulness-Based Cognitive Therapy (iMBCT) in depressed sample and compare the guided intervention to an unguided one. The main questions the study aims to answer are: To what extent completing iMBCT will reduce the severity of depressive symptoms in mild to moderately depressed sample? What are the differences in participants who completed the program or responded to treatment and those who discontinued it? What are the differences in treatment effect between two active conditions (guided and unguided iMBCT) and a passive one - waiting-list group? Researchers will compare two iMBCT interventions with a waiting-list group to assess the therapeutic effects of iMBCT on depression, anxiety and other measures related to the mental health.

Detailed Description
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Depression affects more than 300 millions of people worldwide and is perceived as a largest contributor to global disability (World Health Organisation, 2017). Although the research into depression has been expanding in the last decades (Ledford, 2014), the epidemiological data suggests that a prevalence trend is not decreasing (Ormel, Cuijpers, Jorm et al., 2020). Standard treatment such as psychotherapy or pharmacotherapy is expensive and often associated with other barriers such as limited availability of specialists or waiting-lists (Biringer, Sundfør, Davidson, 2015), which stresses the importance of seeking and investigating other approaches that could address mentioned issues (Rudd & Beidas, 2020). With the development of technology, online psychological interventions have been created to offer more accessible help. Among the various programs aimed at reduction of psychological distress, the ones based on cultivating mindfulness, are exponentially increasing in popularity (Lee, Kim, Webster et al., 2021). One of the few most examined MBI's protocols, considered as gold-standard (Van Dam et al., 2018) is Mindfulness-Based Cognitive Therapy (MBCT, Teasdale, Segal, Williams, 2000). Recent meta-analysis has shown that the intervention could treat current episodes of depression (Goldberg, Tucker, Greene et al., 2019). In the latest National Institute for Clinical Excellence (2022) guidelines MBCT was listed as one of the first-choices for less severe depression. Several studies demonstrated the effectiveness of the online version of MBCT (iMBCT) in treating depressive symptoms (Segal, Dimidjian, Boggs et al., 2020; Ritvo, Knyahnytska, Wang et al., 2021; Nissen, Zachariae, O'Connor et al., 2021), however the field is still fairly new and more research is needed to comprehensively evaluate the clinical utility of the intervention. In this study the investigators decided to evaluate the effectiveness of two conditions of 6-weeks iMBCT (guided and unguided) and compare those two with a waiting-list group. Individuals willing to take part in the study will complete an online screening test. Participants meeting the initical criterions - mild to moderate depressive symptoms - will be asked to take part in a structured clinical interview to increase the validity of the assessment and exclude those with comorbid psychiatric disorders. Then after recruitment, participants will be randomized to one of the three mentioned above conditions. The unguided intervention will consist of the same thematic modules as guided one, however instead of online meetings materials will be uploaded on the platform. Despite pre-test and post-test after six weeks, there will be follow-up measure after 3 months. Another outcome measure will be ecological momentary assessments taking place during the intervention.

Official Title
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Evaluating the Effectiveness of an Online 6-weeks Mindfulness-Based Cognitive Therapy in Depressed Sample: a Randomized Three-arm Clinical Trial

Conditions
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Moderate Depressive Episode, Mild Depressive Episode

Intervention / Treatment
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* Behavioral: Unguided Mindfulness-Based Cognitive Therapy
* Behavioral: Guided Mindfulness-Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting the screening criterions for depression confirmed diagnosis in the clinical interview - mild to moderate depressive episode 18 years old or older informed consent fluent in Polish willing to be randomized to intervention or waiting list group Exclusion Criteria: lack of depressive symptoms constituting mild or moderate episode of depression suicidality severe depression current substance use disorder, psychotic disorders, bipolar current psychotherapy if antidepressant medication: has not been stable over the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unguided iMBCT intervention<br> | Behavioral: Unguided Mindfulness-Based Cognitive Therapy<br>* The unguided iMBCT intervention is divided into six sessions. The sessions are an online adaptation of the regular MBCT. Subsequent sessions are unlocked gradually, once a week. The training consists of audio/video recordings and a workbook. Materials are recorded by a certified MBCT teacher and represent topics raised during regular courses: Awareness and automatic pilot Living in our heads Being present in the body Recognizing aversion Allowing / Letting be How can I best take care of myself? The intervention requires daily commitment of about 30-40 minutes.<br>|
| Experimental: Guided iMBCT intervention<br> | Behavioral: Guided Mindfulness-Based Cognitive Therapy<br>* The guided iMBCT intervention consists of six online meetings in groups of maximum 25 participants. The weekly meetings will be led by an experienced and certified MBCT teacher. The course of the meeting will represent thematically the unguided condition according to the agenda: Introduction to the topic Guided meditation Brief inquiry and discussion Setting tasks for the upcoming week To reduce the number of differences between the conditions as much as possible and narrow it down to the active participation of the teacher, the meetings will be modified version of MBCT and will last maximum 90 minutes. Between the meetings participants will be ask to practice daily 30-40 minutes mindfulness exercises.<br>|
| No Intervention: Waiting list group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of depression - first tool | The Patient Health Questionnaire (PHQ-9): It is a brief self-administered tool for screening and assessing depression severity according to the DSM criteria (Kroenke et al., 2001). Respondents rate the statements on a 4-points scale, yielding a score between 0 and 27. | Baseline, week 6 and week 18 | 
| Change in levels of depression - second tool | To increase the reliability of diagnosis, second tool measuring depression will be used: The Center for Epidemiologic Studies Depression Scale (Radloff, 1977). It is a 20-item instrument with each item rated on a four-point scale ranging from 0 (rarely or none of the time) to 3 (most or all of the time). | Baseline, week 6 and week 18 | 
| Change in levels of anxiety | Generalized Anxiety Disorder (GAD-7) scale: it is a brief tool that consists of seven items measuring worry and anxiety symptoms. (Spitzer et al., 2006). Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity. | Baseline, week 6 and week 18 | 
| Change in levels of self-compassion | Self-compassion will be measured with a short form of Self-Compassion Scale (SCS-SF; Raes et al., 2011). The tool consists of 12 items (eg. 'I try to see my failings as part of the human condition.') to which person refers on a five-point scale. | Baseline, week 6 and week 18 | 
| Change in level of resilience | The level of resilience will be computed with polish Resilience Measurement Scale (The Resiliency Assessment Scale, SPP-25; Ogińska - Bulik, Juczyński, 2008). The scale consists of 25 statements (e. g. I can easily adapt to new situations) to which respondent relates on a five-point Likert scale. | Baseline, week 6 and week 18 | 
| Change in levels of mindfulness | Five Facet Mindfulness Questionnaire-15 (FFMQ-15): It is a short tool to measure mindfulness as a trait. The items will be measured on a 5-point Likert-type scale from 1 (never or rarely true) to 5 (very often or always true). Example items include: I do jobs or tasks automatically without being aware of what I'm doing | Baseline, week 6 and week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of rumination | The Ruminative Response Scale (RRS): It is a 22-item tool measuring responses to depressed mood that are self-focused, symptom-focused, and focused on the possible causes and consequences of dysphoric mood (Nolen-Hoeksema & Morrow, 1991). Each item is rated on a Likert scale ranging from 1 (almost never) to 4 (almost always). | Baseline, week 6 and week 18 | 
| Change in levels of cognitive fusion | The Cognitive Fusion Questionnaire (CFQ): It is a 7-item universal tool measuring cognitive fusion and was created as an alternative to questionnaires that were embedded in narrowed-down contexts, such as anxiety disorders or youth (Gillanders et al., 2014). | Baseline, week 6 and week 18 | 
| Change in levels of experiential avoidance | The Brief Experiential Avoidance Questionnaire (BEAQ): It is a 15-items assessment that was created to measure EA (Gámez et al., 2014). Participants respond to the statements on a 6-point Likert scale (1: strongly disagree; 6: strongly agree). | Baseline, week 6 and week 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness-based cognitive therapy, depression, online intervention