Blended Mindfulness-Based Intervention for Persistent Depression

NCT04576741 | Completed

• 1 other identifier: SPON/2020/08/FHMS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to share all IPD but not any personal information.

Conditions

Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Reductions in depression symptomatology as assessed using the Patient Health Questionnaire-9 (PHQ-9), change measured within 1 week of starting and finishing the course and in week 5 and 9.

  The PHQ-9 has 9 questions to assess the presence and severity of depression according to DSM-IV criteria and takes less than 3 minutes to complete. The PHQ-9 asks about patients' experiences in the last 2 weeks in relation to depression. Responses range from "0" (not at all) to "3" (nearly every day). Presence and severity of depression is scored as follows: 0-4 = minimal, 5-9 = mild, 10-14 = moderate, 15-19 moderately severe, 20-27 = severe. The PHQ-9 has been found to have a high level of validity and reliability (Kroenke, Spitzer, \& Williams, 2001).

  Weeks 0, 5, 9,13.

Secondary Outcomes (6)

• Ability to decenter as assessed by self-report on the Experiences Questionnaire (EQ), change measured within 1 week of starting and finishing the course and in week 5 and 9.

  Weeks 0, 5, 9,13.

• Levels of mindfulness in daily life as assessed using the Five-Facet Mindfulness Questionnaire (FFMQ-15), change measured within 1 week of starting and finishing the course and in week 5 and 9.

  Weeks 0, 5, 9,13.

• Mind wandering and spontaneous thoughts as assessed by the Amsterdam Resting-State Questionnaire 2.0 (ARSQ 2.0), change measured within 1 week of starting and finishing the course and in week 5 and 9.

  Weeks 0, 5, 9,13.

• Symptoms of anxiety as assessed using the Generalised Anxiety Disorder Assessment (GAD-7), change measured within 1 week of starting and finishing the course and in week 5 and 9.

  Weeks 0, 5, 9,13.

• Subjective levels of stress as assessed using the Perceived Stress Scale (PSS), change measured within 1 week of starting and finishing the course and in week 5 and 9.

  Weeks 0, 5, 9,13.

Other Outcomes (3)

• Levels of engagement assessed by participants filling out a simple form each day to record which activities they have completed that day.

  Daily from weeks 1 to 12.

• Practice adherence and skills utilization will be assessed by participants replying to several short messages each day sent to their mobile phone.

  Daily from weeks 1 to 12.

• Participants' views on acceptability, barriers and facilitators to engagement, and their experience and utilization of mindfulness skills, will be assessed in a post-intervention interview via video link, within 1 week of finishing the course.

  Week 13.

Study Arms (2)

bMBI standard practice

EXPERIMENTAL

This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day).

Behavioral: bMBI standard practice

bMBI shorter more frequent practice

EXPERIMENTAL

This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day).

Behavioral: bMBI shorter more frequent practice

Interventions

bMBI standard practice BEHAVIORAL

This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day).

bMBI standard practice

bMBI shorter more frequent practice BEHAVIORAL

This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day).

bMBI shorter more frequent practice

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 Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, \& Williams, 2002).
• 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.

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 nonsuicidal 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 the medication has not been changed during the last four weeks before entry into the study.

Sponsors & Collaborators

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

Study Sites (1)

Surrey and Borders Partnership NHS Foundation Trust

Guildford, Surrey, KT16 9FG, United Kingdom

Location

Study Officials

• Jonathan Hamilton

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: October 6, 2020
• Study Start: March 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 27, 2022
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)