Effects of Mindfulness on Brain Functioning in Depressed Patients

NCT05650177 | Completed

• 1 other identifier: USurrey
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is a common disorder that often takes a recurrent or chronic course. Recent research has indicated that such courses are associated with significant changes in brain functioning including changes in strength of functional connectivity between regions of the default mode network, a large-scale brain network involved in spontaneous thinking and rumination, and the ability to suppress this network. Training in mindfulness has been found to be an effective treatment for patients with recurrent and chronic courses of depression and there is evidence for beneficial effects on brain structure and functioning. However, it remains unclear whether and in how far the training may serve to reverse brain changes in recurrent and chronic courses of depression. The aim of this research is to test the effects of sustained training in mindfulness meditation on default mode network connectivity and suppression in patients suffering from recurrent or chronic depression. The investigators will invite currently depressed patients with a recurrent or chronic course of the disorder (N = 36) to take part in a 6-month mindfulness intervention and investigate changes in default-mode network connectivity and suppression over repeated assessments. Building on our previous research, the intervention will use a blended format that combines an online app offering psychoeducational materials and meditation guidance with brief individual therapy sessions delivered via videoconference. Eligible participants will be asked to complete questionnaires and take part in brain scans before the start of the treatment, 3 months after the start of the treatment and after the end of treatment.

Conditions

Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in activity within the brain's 'default mode network'.

  The primary outcome measure is changes in activity within the brain's 'default mode network', measured during a working memory task. The default mode network (DMN) refers to an interconnected group of brain structures (including medial prefrontal cortex, posterior cingulate cortex, and the inferior parietal lobule) that is more active when we are not involved in any specific mental exercise, e.g. just daydreaming, recalling memories or thinking about the future. Research has found links between activity in the DMN and mental disorders including depression and anxiety, while mindfulness practise has been shown to influence DMN activity.

  0 months, 3 months, and 6 months.

Secondary Outcomes (7)

• Patient Health Questionnaire-9 (PHQ-9)

  0 months, 3 months, and 6 months.

• Experiences Questionnaire (EQ)

  0 months, 3 months, and 6 months.

• Five-Facet Mindfulness Questionnaire (FFMQ-15)

  0 months, 3 months, and 6 months.

• Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0)

  0 months, 3 months, and 6 months.

• Generalised Anxiety Disorder Assessment (GAD-7)

  0 months, 3 months, and 6 months.

Study Arms (1)

Receiving intervention.

EXPERIMENTAL

Patients with persistent depression who are receiving the intervention.

Behavioral: blended Mindfulness-Based Intervention (bMBI)

Interventions

blended Mindfulness-Based Intervention (bMBI) BEHAVIORAL

The blended Mindfulness-Based Intervention (bMBI) is a 24-week online course 'blended' with therapist support via video link. The entire course is completed online and requires no in person contact. The bMBI follows the general structure of Mindfulness-Based Cognitive Therapy (MBCT) with an added emphasis on the cultivation of self-compassion. The bMBI comprises of 9-themed sessions spread out over the 24-weeks. Each session involves: video instructions, written information, psycho-educational exercises, and guided meditation practices. Participants meditate for 30-minutes each day. Additional homework involves short daily activities designed to incorporate mindfulness into daily life and keeping a journal about experiences within and around the practices and exercises. The therapist sessions are every two weeks and last for 45-minutes and help participants overcome any problems they experience.

Receiving intervention.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A current diagnosis of Major Depression as assessed by SAGE-SR (Series of Assessments to Guide Evaluation Self Report (Brodey et al., 2018).
• A chronic or recurrent lifetime history of depression, with either chronic persistence of symptoms or a history of at least three previous episodes of depression, two of which needed to have occurred during the last two years.
• Self-reported severity of current symptoms on a clinical level as indicated by a PHQ-9 score of 10 or more.
• Age 18 to 65 thus excluding cases of late life depression given that such cases might differ in aetiology.
• Fluency in spoken and written English.
• Have individual access to a computer or mobile device with internet connection and video link.
• Fully committed to the intervention and assessments as assessed by the Participation Form.

You may not qualify if:

• History of schizophrenia, schizoaffective disorder, bipolar disorder, current abuse of alcohol or other substances, organic mental disorder, pervasive developmental delay, primary diagnosis of obsessive-compulsive disorder or eating disorder, or regular non-suicidal self-injury.
• Current treatment with CBT more than once a month.
• Regular meditation practice (meditating more than once per week).
• Inability to complete research assessments through difficulty with English, visual impairment, or cognitive difficulties.
• We will allow patients who are currently taking antidepressants into the study provided that their medication has not been changed during the last four weeks before entry into the study.
• People with heart pacemakers and clips or other metal items, which have been implanted into the body by a surgeon. This is because they would not safe in the brain scanner.
• Suffer from claustrophobia.

Sponsors & Collaborators

• University of Surrey: lead
• Surrey and Borders Partnership NHS Foundation Trust: collaborator

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Study Officials

• Jonathan D Hamilton

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 14, 2022
• Study Start: June 6, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)