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

Primary Purpose

Moderate Depressive Episode, Mild Depressive Episode

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unguided Mindfulness-Based Cognitive Therapy
Guided Mindfulness-Based Cognitive Therapy
Sponsored by
University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Depressive Episode focused on measuring mindfulness-based cognitive therapy, depression, online intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Unguided iMBCT intervention

    Guided iMBCT intervention

    Waiting list group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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").
    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.
    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.
    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.
    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"

    Secondary Outcome Measures

    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).
    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).
    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").

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    June 24, 2023
    Sponsor
    University of Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05919875
    Brief Title
    Online Mindfulness-Based Cognitive Therapy in Depressed Sample
    Acronym
    iMBCT
    Official Title
    Evaluating the Effectiveness of an Online 6-weeks Mindfulness-Based Cognitive Therapy in Depressed Sample: a Randomized Three-arm Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Warsaw

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate Depressive Episode, Mild Depressive Episode
    Keywords
    mindfulness-based cognitive therapy, depression, online intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    324 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Unguided iMBCT intervention
    Arm Type
    Experimental
    Arm Title
    Guided iMBCT intervention
    Arm Type
    Experimental
    Arm Title
    Waiting list group
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Unguided Mindfulness-Based Cognitive Therapy
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Guided Mindfulness-Based Cognitive Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in levels of depression - first tool
    Description
    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.
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in levels of depression - second tool
    Description
    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").
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in levels of anxiety
    Description
    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.
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in levels of self-compassion
    Description
    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.
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in level of resilience
    Description
    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.
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in levels of mindfulness
    Description
    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"
    Time Frame
    Baseline, week 6 and week 18
    Secondary Outcome Measure Information:
    Title
    Change in levels of rumination
    Description
    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).
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in levels of cognitive fusion
    Description
    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).
    Time Frame
    Baseline, week 6 and week 18
    Title
    Change in levels of experiential avoidance
    Description
    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").
    Time Frame
    Baseline, week 6 and week 18
    Other Pre-specified Outcome Measures:
    Title
    Ecological momentary assessment
    Description
    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
    Time Frame
    Week 1,2 and 6
    Title
    Working Alliance
    Description
    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).
    Time Frame
    week 2
    Title
    Credibility and Expectancy
    Description
    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).
    Time Frame
    week 2
    Title
    Attitudes towards Psychological Online Interventions
    Description
    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) .
    Time Frame
    Baseline
    Title
    Locus of Control in Well-Being
    Description
    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)
    Time Frame
    Baseline
    Title
    Social support
    Description
    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.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jan Wardęszkiewicz, Msc.
    Phone
    +48698621861
    Email
    jan.wardeszkiewicz@psych.uw.edu.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Wardęszkiewicz, MSc
    Organizational Affiliation
    University of Warsaw
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paweł Holas, Ph.D.
    Organizational Affiliation
    University of Warsaw
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We will provide data upon reasonable request.
    Citations:
    PubMed Identifier
    30600627
    Citation
    Ormel J, Cuijpers P, Jorm AF, Schoevers R. Prevention of depression will only succeed when it is structurally embedded and targets big determinants. World Psychiatry. 2019 Feb;18(1):111-112. doi: 10.1002/wps.20580. No abstract available.
    Results Reference
    background
    PubMed Identifier
    10965637
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29126747
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31995132
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33688840
    Citation
    Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, Linklater R, Bai S, Kirk M, Katz J, Harber L, Daskalakis Z. Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 10;23(3):e24380. doi: 10.2196/24380.
    Results Reference
    background

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