Online Mindfulness-Based Cognitive Therapy in Depressed Sample

NCT05919875 | Completed

• 1 other identifier: UWarsaw
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate Depressive Episode; Mild Depressive Episode

Keywords

mindfulness-based cognitive therapy; depression; online intervention

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Change in levels of rumination

  Baseline, week 6 and week 18

• Change in levels of cognitive fusion

  Baseline, week 6 and week 18

• Change in levels of experiential avoidance

  Baseline, week 6 and week 18

Other Outcomes (6)

• Ecological momentary assessment

  Week 1,2 and 6

• Working Alliance

  week 2

• Credibility and Expectancy

  week 2

Study Arms (3)

Unguided iMBCT intervention

EXPERIMENTAL

Behavioral: Unguided Mindfulness-Based Cognitive Therapy

Guided iMBCT intervention

EXPERIMENTAL

Behavioral: Guided Mindfulness-Based Cognitive Therapy

Waiting list group

NO INTERVENTION

Interventions

Unguided Mindfulness-Based Cognitive Therapy BEHAVIORAL

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: 1. Awareness and automatic pilot 2. Living in our heads 3. Being present in the body 4. Recognizing aversion 5. Allowing / Letting be 6. "How can I best take care of myself?" The intervention requires daily commitment of about 30-40 minutes.

Unguided iMBCT intervention

Guided Mindfulness-Based Cognitive Therapy BEHAVIORAL

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.

Guided iMBCT intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meeting the screening criterions for depression
• confirmed diagnosis in the clinical interview - mild to moderate depressive episode
• years old or older
• informed consent
• fluent in Polish
• willing to be randomized to intervention or waiting list group

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warsaw: lead

Study Sites (1)

University of Warsaw

Warsaw, Poland

Location

Related Publications (5)

• 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.

  PMID: 6313244 BACKGROUND

• 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.

  PMID: 10965637 BACKGROUND

• 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.

  PMID: 29126747 BACKGROUND

• 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.

  PMID: 31995132 BACKGROUND

• 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.

  PMID: 7991990 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jan Wardęszkiewicz, MSc

  University of Warsaw

  PRINCIPAL INVESTIGATOR

• Paweł Holas, Ph.D.

  University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 26, 2023
• Study Start: March 18, 2024
• Primary Completion: July 31, 2024
• Study Completion: October 29, 2024
• Last Updated: November 25, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)