Online Mindfulness-Based Cognitive Therapy in Depressed Sample (iMBCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate Depressive Episode; Mild Depressive Episode
• Intervention / Treatment: Behavioral: Unguided Mindfulness-Based Cognitive Therapy; Behavioral: Guided Mindfulness-Based Cognitive Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list group
Experimental: Unguided iMBCT intervention	Behavioral: Unguided Mindfulness-Based Cognitive Therapy; 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.
Experimental: Guided iMBCT intervention	Behavioral: Guided Mindfulness-Based Cognitive Therapy; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological momentary assessment	EMA is a process measure that allows to deepen the understanding of mechanisms of change in the intervention. Our EMA consists of: 4 questions about depression; 3 questions about mindfulness; 4 questions about ruminations; 1 affect scale	Week 1,2 and 6
Working Alliance	Working Alliance Inventory tailored to the Internet condition (WAI-TECH-SF): it is a 12-item questionnaire designed to assess the therapeutic alliance with the online program. Participants will response on a seven-point Likert scale, ranging from 1 (never) to 7 (always) (Herrero at al., 2020).	week 2
Credibility and Expectancy	Credibility and Expectancy Questionnaire (CEQ) is a 6-item tool assessing treatment expectancy based on the participant's beliefs. The questionnaire consists of two factors: expectancy (with three questions rated on a 10-point scale, ranging from 1 to 9) and credibility (with one question rated on a 10-point scale and two questions rated on a 1-100% scale) (Devilly, Borkovec, 2000).	week 2
Attitudes towards Psychological Online Interventions	The Attitudes towards Psychological Online Interventions Questionnaire (APOI): it is a 16-item tool that was created to assesses respondents' acceptance of Internet interventions along four dimensions (Skepticism and Perception of Risks, Confidence in Effectiveness, Technologization Threat, and Anonymity Benefits). The answers are collected on a five-point Likert-scale (1 = totally agree, 2 = rather agree, 3 = not sure, 4 = rather disagree, 5 = totally disagree)(Schröder et al. 2015) .	Baseline
Locus of Control in Well-Being	A Locus of Control Specific to Well-Being (WB-LOC12): it is a 12-item tool that aims to identify the patients' beliefs concerning the main forces influencing their well-being (Farnier et al., 2021)	Baseline
Social support	The Multidimensional Scale of Perceived Social Support (MSPSS:it is a 12-item tool developed by Zimet and collaborators (1988) as a self-report measure to assess per- ceived social support.	Baseline

Collaborators and Investigators

• Sponsor: University of Warsaw
• Investigators: Principal Investigator: Jan Wardęszkiewicz, MSc, University of Warsaw; Study Chair: Paweł Holas, Ph.D., University of Warsaw

Publications and helpful links

General Publications

• Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.
• Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
• Surewicz WK. Effect of osmotic gradient on the physical properties of membrane lipids in liposomes. Chem Phys Lipids. 1983 Jul;33(1):81-5. doi: 10.1016/0009-3084(83)90010-5.
• Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693. Erratum In: JAMA Psychiatry. 2020 May 1;77(5):545. doi: 10.1001/jamapsychiatry.2020.0348.
• Chariyalertsak S, Sugano K, Ohkura H, Mori Y. Comparison of c-erbB-2 oncoprotein expression in tissue and serum of patients with stomach cancer. Tumour Biol. 1994;15(5):294-303. doi: 10.1159/000217904.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: depression; online intervention; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: UWarsaw

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will provide data upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No