Online Mindfulness-Based Cognitive Therapy in Depressed Sample

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2024-10-29

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.

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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.

Conditions

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Moderate Depressive Episode Mild Depressive Episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unguided iMBCT intervention

Group Type EXPERIMENTAL

Unguided Mindfulness-Based Cognitive Therapy

Intervention Type 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.

Guided iMBCT intervention

Group Type EXPERIMENTAL

Guided Mindfulness-Based Cognitive Therapy

Intervention Type 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.

Waiting list group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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:

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes