Clinical trial NCT03425487: Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services
Official title: Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxious-Depressive
Keywords: Mindfulness
Compassion
Mental Health Services
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression Anxiety Stress Scales
timeFrame: Baseline
measure: Depression Anxiety Stress Scales
timeFrame: Baseline
measure: Depression Anxiety Stress Scales
timeFrame: Baseline
measure: Depression Anxiety Stress Scales
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group
measure: Depression Anxiety Stress Scales
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group
measure: Depression Anxiety Stress Scales
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Depression Anxiety Stress Scales
timeFrame: Six-months follow-up
measure: Depression Anxiety Stress Scales
timeFrame: Six-months follow-up
measure: Depression Anxiety Stress Scales
timeFrame: Six-months follow-up
Secondary outcomes:
measure: Sociodemographic data such as gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Sociodemographic data such as gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Sociodemographic data such as gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline
measure: Five Facet Mindfulness Questionnaire
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group
measure: Five Facet Mindfulness Questionnaire
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group
measure: Five Facet Mindfulness Questionnaire
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Five Facet Mindfulness Questionnaire
timeFrame: Six-months follow-up
measure: Five Facet Mindfulness Questionnaire
timeFrame: Six-months follow-up
measure: Five Facet Mindfulness Questionnaire
timeFrame: Six-months follow-up
measure: Self-Compassion Scale
timeFrame: Baseline
measure: Self-Compassion Scale
timeFrame: Baseline
measure: Self-Compassion Scale
timeFrame: Baseline
measure: Self-Compassion Scale
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group
measure: Self-Compassion Scale
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group
measure: Self-Compassion Scale
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: Self-Compassion Scale
timeFrame: Six-months follow-up
measure: Self-Compassion Scale
timeFrame: Six-months follow-up
measure: Self-Compassion Scale
timeFrame: Six-months follow-up
measure: EuroQol-5D. Health related quality of life
timeFrame: Baseline
measure: EuroQol-5D. Health related quality of life
timeFrame: Baseline
measure: EuroQol-5D. Health related quality of life
timeFrame: Baseline
measure: EuroQol-5D. Health related quality of life
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group
measure: EuroQol-5D. Health related quality of life
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group
measure: EuroQol-5D. Health related quality of life
timeFrame: Post-treatment 8 weeks from baseline in TAU control group
measure: EuroQol-5D. Health related quality of life
timeFrame: Six-months follow-up
measure: EuroQol-5D. Health related quality of life
timeFrame: Six-months follow-up
measure: EuroQol-5D. Health related quality of life
timeFrame: Six-months follow-up
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Six-months follow-up
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Six-months follow-up
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Six-months follow-up
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Hospital Universitario de la Plana
Study officials:
References:
citation: Collado-Navarro C, Navarro-Gil M, Perez-Aranda A, Lopez-Del-Hoyo Y, Garcia-Campayo J, Montero-Marin J. Effectiveness of mindfulness-based stress reduction and attachment-based compassion therapy for the treatment of depressive, anxious, and adjustment disorders in mental health settings: A randomized controlled trial. Depress Anxiety. 2021 Nov;38(11):1138-1151. doi: 10.1002/da.23198. Epub 2021 Jul 20.
citation: Montero-Marin J, Collado-Navarro C, Navarro-Gil M, Lopez-Montoyo A, Demarzo M, Herrera-Mercadal P, Barcelo-Soler A, Garcia-Campayo J. Attachment-based compassion therapy and adapted mindfulness-based stress reduction for the treatment of depressive, anxious and adjustment disorders in mental health settings: a randomised controlled clinical trial protocol. BMJ Open. 2019 Oct 8;9(10):e029909. doi: 10.1136/bmjopen-2019-029909.