CompletedNot Applicable

Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services

Spain90 participantsStarted 2019-01-01

Plain-language summary

The aim of this study is to assess and compare the benefits of twopsychological interventions added to the usual treatment of patients whocome to mental health. Patients will be randomly assigned to the followingconditions: Mindfulness-Based Stress Reduction (MBSR), Attachment-BasedCompassion Therapy (ABCT) and a Treatment As Usual (TAU) Group. Theparticipants in the two psychological intervention groups will also receive usualpsychological/psychiatric treatment managed by their specialist. Mindfulnessand Compassion groups will be composed of 33 participants each, and TAU group will be composed of 64 participants (total sample n = 130). The principal hypothesis is that 'ABCT + TAU' will be more effective than'MBSR + TAU' for treating depressive and/or anxiety symptoms in patients attending mental health settings. Secondary hypothesis are: 1) 'MBSR + TAU'and 'ABCT + TAU' will be more effective than 'TAU alone' for treatinganxiety and/or depressive symptoms in patients attending mental health settings; 2) mindfulness will be a mediator of the 'MBSR + TAU' program improvements, while self-compassion will be a mediator of the corresponding'ABCT + TAU'; and 3) 'ABCT + TAU' will present more cost-effectiveness than 'MBSR + TAU' and both ABCT + TAU' and 'MBSR + TAU' programs will present more cost-effectiveness than TAU alone.

Who can participate

Age range

18 Years – 75 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: * Age: 18-75 years old. * Depressive and/or anxious disorder, or adjustment disorder with depressive or/and anxious symptomatology, according to clinical criteria based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5). * Disorder of mild or moderate severity according to clinical criteria (based on DSM-5). * Understand perfectly spoken and written Spanish. * Grant a written informed consent form Exclusion Criteria: * To have done any type of meditative/contemplative practice during the previous year. * Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.). * Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.). * Any medical, infectious or degenerative disease that may affect mood. * Presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk.

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

Depression Anxiety Stress Scales

Timeframe: Baseline

Depression Anxiety Stress Scales

Timeframe: Baseline

Depression Anxiety Stress Scales

Timeframe: Baseline

Depression Anxiety Stress Scales

Timeframe: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group

Depression Anxiety Stress Scales

Timeframe: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group

Depression Anxiety Stress Scales

Timeframe: Post-treatment 8 weeks from baseline in TAU control group

Depression Anxiety Stress Scales

Timeframe: Six-months follow-up

Trial details

NCT IDNCT03425487

SponsorHospital Miguel Servet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-30

View on ClinicalTrials.gov More Anxious-Depressive trials

Plain-language summary

Who can participate

Age range

18 Years – 75 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.

What they're measuring

Depression Anxiety Stress Scales

Timeframe: Baseline

Depression Anxiety Stress Scales

Timeframe: Baseline

Depression Anxiety Stress Scales

Timeframe: Baseline

Depression Anxiety Stress Scales

Timeframe: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group

Depression Anxiety Stress Scales

Timeframe: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group

Depression Anxiety Stress Scales

Timeframe: Post-treatment 8 weeks from baseline in TAU control group

Depression Anxiety Stress Scales

Timeframe: Six-months follow-up