NCT03425487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 1, 2018

Last Update Submit

February 10, 2020

Conditions

Anxious-Depressive

Keywords

MindfulnessCompassionMental Health Services

Outcome Measures

Primary Outcomes (9)

  • Depression Anxiety Stress Scales

    In the MBSR based intervention 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.

    Baseline

  • Depression Anxiety Stress Scales

    In the ABCT based intervention 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.

    Baseline

  • Depression Anxiety Stress Scales

    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.

    Baseline

  • Depression Anxiety Stress Scales

    In the MBSR based intervention 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.

    Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group

  • Depression Anxiety Stress Scales

    In the ABCT based intervention 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.

    Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group

  • Depression Anxiety Stress Scales

    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.

    Post-treatment 8 weeks from baseline in TAU control group

  • Depression Anxiety Stress Scales

    In the MBSR based intervention 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.

    Six-months follow-up

  • Depression Anxiety Stress Scales

    In the ABCT based intervention 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.

    Six-months follow-up

  • Depression Anxiety Stress Scales

    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.

    Six-months follow-up

Secondary Outcomes (36)

  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level

    Baseline

  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level

    Baseline

  • Sociodemographic data such as gender, age, marital status, education, occupation, economical level

    Baseline

  • Five Facet Mindfulness Questionnaire

    Baseline

  • Five Facet Mindfulness Questionnaire

    Baseline

  • +31 more secondary outcomes

Study Arms (3)

MBSR+TAU

EXPERIMENTAL

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.

Behavioral: Mindfulness based Intervention

ABCT+TAU

EXPERIMENTAL

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.

Behavioral: Compassion based Intervention

TAU

ACTIVE COMPARATOR

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

Other: TAU

Interventions

Mindfulness based InterventionBEHAVIORAL

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

MBSR+TAU
Compassion based InterventionBEHAVIORAL

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.

ABCT+TAU
TAUOTHER

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

TAU

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de la Plana

Castellon, Spain

Location

Related Publications (2)

  • 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.

    PMID: 34288280DERIVED

  • 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.

    PMID: 31597650DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

January 1, 2019

Primary Completion

April 30, 2019

Study Completion

October 31, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

The data generated by this trial will be made available upon reasonable request to researchers i) who provide a methodologically sound proposal and ii) whose proposed use of the data has been approved by an independent ethical review committee. The data sharing plan will include all of the individual anonymized and completely de-identified participant data collected during the trial, as well as other related documents such as the study protocol, the statistical analysis plan and the data dictionary with descriptive labels. The database will be encrypted and password protected.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will become available immediately following each publication with no end date and for any analytical purpose that is related to achieve aims in the original approved proposal.
Access Criteria
Passwords will be provided by the corresponding author to interested researchers that meet the both previously described criteria.

Locations

ES(1)