Clinical trial NCT04576741: Blended Mindfulness-Based Intervention for Persistent Depression
Official title: Testing the Feasibility and Acceptability of a Blended Mindfulness-Based Intervention for Persistent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Depressive Disorder
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Mind and Life Europe
name: Surrey and Borders Partnership NHS Foundation Trust
First posted: 2020-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

1. A current diagnosis of Major Depression as assessed by Structured Clinical Interview for DSM IV (First, Spitzer, Gibbon, \& Williams, 2002).
2. 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.
3. Self-reported severity of current symptoms on a clinical level as indicated by a PHQ-9 score of 10 or more.
4. Age 18 to 65 thus excluding cases of late life depression given that such cases might diﬀer in aetiology.
5. Fluency in spoken and written English.
6. Have individual access to a computer or mobile device with internet connection and video link.

Exclusion criteria:

1. 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.
2. Current treatment with CBT more than once a month.
3. Regular meditation practice (meditating more than once per week).
4. Inability to complete research assessments through difficulty with English, visual impairment, or cognitive difficulties.
5. 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.

Primary outcomes:
measure: 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.
timeFrame: Weeks 0, 5, 9,13.
Secondary outcomes:
measure: 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.
timeFrame: Weeks 0, 5, 9,13.
measure: 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.
timeFrame: Weeks 0, 5, 9,13.
measure: 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.
timeFrame: Weeks 0, 5, 9,13.
measure: 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.
timeFrame: Weeks 0, 5, 9,13.
measure: 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.
timeFrame: Weeks 0, 5, 9,13.
measure: Mental wellbeing as assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), change measured within 1 week of starting and finishing the course and in week 5 and 9.
timeFrame: Weeks 0, 5, 9,13.
Other outcomes:
measure: Levels of engagement assessed by participants filling out a simple form each day to record which activities they have completed that day.
timeFrame: Daily from weeks 1 to 12.
measure: Practice adherence and skills utilization will be assessed by participants replying to several short messages each day sent to their mobile phone.
timeFrame: Daily from weeks 1 to 12.
measure: 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.
timeFrame: Week 13.
Locations:
city: Guildford
country: United Kingdom
facility: Surrey and Borders Partnership NHS Foundation Trust
state: Surrey
Study officials:
affiliation: University of Surrey
name: Jonathan Hamilton
role: PRINCIPAL_INVESTIGATOR
References: