NCT05919875

Online Mindfulness-Based Cognitive Therapy in Depressed Sample

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Moderate Depressive Episode
• Mild Depressive Episode

Interventions

Type	Name	Description
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: 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.
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.

Timeline

• Start date: 2024-03-18
• Primary completion: 2024-07-31
• Completion: 2024-10-29
• First posted: 2023-06-26
• Last updated: 2024-11-25

Locations

1 site across 1 country: Poland