DOI: 10.3886/e110024v1
title: Attachment-Based Compassion Therapy (ABCT) and Mindfulness-Based Stress Reduction (MBSR) for the Treatment of Depressive, Anxious and Adjustment Disorders in Mental Health Settings: A Randomized Controlled Trial Protocol

description: Introduction: Depressive, anxiety and adjustment
disorders are very prevalent among mental health outpatients. The lack of
funding for mental health problems produces inefficient results and a high
burden of disease. New cost-effective group interventions aimed at treating these
symptoms might be an appropriate solution to reduce the healthcare burden in
mental health units. Mindfulness-based interventions (MBIs) have shown
significant reductions in anxious, depressive and adjustment symptomatology,
and recent research highlights the influence of compassion as a key mechanism
of change. However, MBIs only address compassion implicitly, and only compassion-based
protocols consider it a core aspect of psychotherapy. In this randomized
controlled clinical trial, we hypothesize that the provision of attachment-based
compassion therapy (ABCT), which is a compassion-based protocol, will be more
effective than mindfulness-based stress reduction (MBSR), which is a classical
MBI programme, for treating depressive, anxious and adaptive symptoms in
patients in mental health settings. 

Methods and analysis: Approximately 90 patients
suffering from depressive, anxious or adjustment disorders and recruited from
Spanish mental health settings will be randomized to receive 8 weekly 2-hour
group-based sessions of ABCT, 8 weekly 2.5-hour group-based sessions of MBSR,
or treatment as usual (TAU), with a 1:1:1 allocation rate. Patients of the ABCT
and MBSR groups will also receive TAU. The primary outcome will be general
affective distress measured through the “Depression Anxiety Stress Scales”
(DASS-21) at baseline, post-test and six-month follow-up. Other outcomes will
be clinical impression, quality of life, mindfulness, self-compassion and the
use of healthcare services. Intention-to-treat analysis using linear mixed
models adjusted for baseline scores and routine sociodemographic that could
show baseline differences will be conducted. Per-protocol and secondary outcome
analyses will also be performed. A Data Monitoring Committee composed of the
trial manager, the ABCT and MBSR teachers and an independent clinical
psychologist will monitor for possible negative side effects.
description: Response Rates: We
will need approximately 75 patients: 25 in the MBSR condition, 25 in the ABCT
group, and 25 in the TAU condition. Assuming a patient loss to follow-up of approximately
15–20%, the total sample
size needed will be established at 90 patients (30 in each group
description: Presence of Common Scales: Main outcome: The main efficacy outcome will be general affective distress, and it will be assessed through the brief version of the “Depression Anxiety Stress Scales” (DASS-21). It is a self-report questionnaire composed of the three negative
affectivity sub-scales of depression, anxiety and stress. Each sub-scale is formed
by 7 items, and each item comprises a statement and four Likert-type response
options to reflect severity (rated from 0 “did not apply to me at all” to 3
“applied to me very much, or most of the time”)













<br>Secondary outcomes: <br>European Quality of Life Scale (Euroqol-5D): It includes information about mobility,
personal care, daily activities, pain/discomfort, anxiety/depression, and a
personal estimate of the present general health state compared with the
previous 12 months, all of them rated on a Likert-type scale with 3 response
options. In addition, this questionnaire includes a visual analogue scale (VAS)
to measure the present health state, with all the possible values from 0 to
100. <br><br>













Five Facet Mindfulness Questionnaire (FFMQ): The
FFMQ is a 39-item self-report measure of mindfulness.
It comprises five facets: observing, describing, acting with awareness,
non-judging of inner experience and non-reactivity to inner experience.
Respondents indicate on a 5-point Likert-type scale the degree to which each
item is true for them (ranging from 1 “never or very rarely true” to 5 “very
often or always true”). Higher scores suppose higher levels of mindfulness. The
facet scores can be combined to produce a total mindfulness score that ranges
from 39 to 195    <br><br>Self-Compassion Scale (SCS): It is a 26-item questionnaire designed to assess
the components of self-compassion across the facets of common humanity,
mindfulness and self-kindness. The SCS uses a 5-point Likert-type scale,
ranging from 1 (“almost never”) to 5 (“almost always”). Higher scores indicate
higher levels of self-compassion.<br><br>













Client Service Receipt Inventory (CSRI): It has been designed to collect retrospective data on service utilization in
the previous 8 months from the baseline assessment and from the previous 8 months
from the follow-up measure.













 <br>Socio-demographic data: 
















age, gender, marital status, number of children, living location, education,
employment, economic level .  <br>
description: face-to-face interview~~on-site questionnaire~~The data will be
treated anonymously and will be stored in a computer of the research group
centre; paper and pencil questionnaires will be kept locked in an archive. Data from outcome measures will be separated from
identifying information, and advanced encryption standard (AES) strategies concerning
data encryption and use of personal passwords will be implemented to guarantee
the protection of personal information.
description: Patients suffering from depressive, anxious or adjustment disorders and
recruited from Spanish mental health settings.
description: multi-centre,
randomized controlled clinical trial (RCT) formed by three parallel arms, with pre-treatment,
post-treatment, and 6-month follow-up measures, and a 1:1:1 allocation rate
among groups.