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 range18 Years – 75 Years

SexALL

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.

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

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 range18 Years – 75 Years

SexALL

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

Depression Anxiety Stress Scales

Timeframe: Six-months follow-up