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

University Hospital Miguel Servet

Status: Completed

Conditions: Anxious-Depressive

Treatments: Behavioral: Mindfulness based Intervention; Other: TAU; Behavioral: Compassion based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03425487

7/2017

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

MBSR+TAU

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness based Intervention

ABCT+TAU

Experimental group

Description:

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.

Treatment:

Behavioral: Compassion based Intervention

TAU

Active Comparator group

Description:

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

Treatment:

Other: TAU