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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxious-Depressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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MBSR+TAU

Mindfulness based Intervention (MBSR) + Usual specialized treatment in mental health. MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.

Group Type EXPERIMENTAL

Mindfulness based Intervention

Intervention Type BEHAVIORAL

MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months

ABCT+TAU

Compassion based Intervention (ABCT) + Usual specialized treatment in mental health. ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.

Group Type EXPERIMENTAL

Compassion based Intervention

Intervention Type BEHAVIORAL

ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.

TAU

Usual specialized treatment in mental health (psychological or/and psychiatric)

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type OTHER

Usual specialized treatment in mental health (psychological or/and psychiatric)

Interventions

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Mindfulness based Intervention

MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months

Intervention Type BEHAVIORAL

Compassion based Intervention

ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.

Intervention Type BEHAVIORAL

TAU

Usual specialized treatment in mental health (psychological or/and psychiatric)

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No