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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

Version
1
Resource Type
Dataset : clinical data, medical records
Creator
  • García-Campayo, Javier (IIS Aragon)
Publication Date
2019-01-01
Free Keywords
depression (psychology); anxiety; primary care
Description
  • Abstract

    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.
  • Technical Information

    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
  • Technical Information

    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”)
    Secondary outcomes:
    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.

    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

    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.

    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.
    Socio-demographic data: age, gender, marital status, number of children, living location, education, employment, economic level .
Temporal Coverage
  • 2019-01-01 / 2019-11-30
    Time Period: Tue Jan 01 00:00:00 EST 2019--Sat Nov 30 00:00:00 EST 2019
Geographic Coverage
  • Spain
Sampled Universe
Patients suffering from depressive, anxious or adjustment disorders and recruited from Spanish mental health settings.
Sampling
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.
Collection Mode
  • 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. 

Availability
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Update Metadata: 2019-06-14 | Issue Number: 2 | Registration Date: 2019-06-04

García-Campayo, Javier (2019): 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. Version: 1. ICPSR - Interuniversity Consortium for Political and Social Research. Dataset. https://doi.org/10.3886/E110024V1