CompletedNot Applicable

Blended Mindfulness-Based Intervention for Persistent Depression

United Kingdom24 participantsStarted 2021-03-01

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT04576741

SponsorUniversity of Surrey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

View on ClinicalTrials.gov More Persistent Depressive Disorder trials