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

Not Applicable

Completed

• Conditions: Anxious-Depressive
• Interventions: Behavioral: Mindfulness based Intervention; Other: TAU; Behavioral: Compassion based Intervention

• Registration Number: NCT03425487
• Lead Sponsor: Hospital Miguel Servet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2019-01-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-10-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBSR+TAU	Mindfulness based Intervention	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.
TAU	TAU	Usual specialized treatment in mental health (psychological or/and psychiatric)
ABCT+TAU	Compassion based Intervention	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.

Primary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scales	Six-months follow-up	In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.

Secondary Outcome Measures

Name	Time	Method
EuroQol-5D. Health related quality of life	Six-months follow-up	In the TAU group control. The EuroQol-5D is a standardized instrument for measuring generic health status. The construct "health status" is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level scale.
Client Service Receipt Inventory (CSRI)	Six-months follow-up	In the TAU group control
Sociodemographic data such as gender, age, marital status, education, occupation, economical level	Baseline	In the TAU control group
Five Facet Mindfulness Questionnaire	Six-months follow-up	In the TAU group control. The FFMQ is a 39-item questionnaire that measures five facets of mindfulness: observe (8 items), describe (8 items), actaware (8 items), nonjudge (8 items) and nonreact (7 items). The range score for each subescale is: "observe" (40 points); "describe" (40 points); "actaware" (40 points); "nonjudge"(40 points); "nonreact" (35 points). For all subscales, a high score is considered to be more presence of the construct. Finally, the subscales can be summed to obtain a general score.
Self-Compassion Scale	Six-months follow-up	In the TAU group control. This scale is currently the only self-report instrument to measure self-compassion. The SCS is divided into six subscales: 4-item Self-Kindness; 4-item Self-Judgment; 4-item Common Humanity; 4-item Isolation; 4-item Mindfulness; and 4-item Over-Identification. The items can be rated on a five-point likert scale with 1 indicating almost never and 5 indicating almost always. After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion.

Trial Locations

Locations (1)

Hospital Universitario de la Plana; 🇪🇸 Castellón De La Plana, Spain