Clinical trial NCT03918746: Feasibility of the Internet Attachment-Based Compassion Therapy (iABCT)
Official title: The Feasibility of the Internet Attachment-Based Compassion Therapy (iABCT) for General Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Compassion
Keywords: compassion
internet-based Interventions
feasibility
meditation
attachment
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Generalitat Valenciana
name: European Social Fund
First posted: 2019-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the feasibility, acceptability and preliminary efficacy of the internet Attachment-based compassion Therapy (iABCT) to promote wellbeing and mental health for the general population.

A feasibility open trial and single-arm study will be conducted with three measurement points: at baseline (pre-intervention), immediately after the intervention (post-), and 3-month follow-up, where participants will be allocated to iABCT.

To the best of our knowledge, this is the first study to explore the feasibility and preliminary efficacy of Compassion-based Intervention (CBI) delivered over the internet in Spanish.

Detailed description: Compassion refers to a multidimensional psychological construct that involves the feeling that arises in presence of another's suffering and implies the desire to help. There is a growing number of studies pointing out the benefits of Compassion-based Interventions (CBI) and their association with psychological health. CBI are focused on training compassion to others and/or towards oneself (self-compassion) employing formal and informal meditation practices. Recent scientific literature is emerging to prove the feasibility and efficacy of cultivating compassion over the Internet and, thus, delivering self-applied online CBI.

The aim of this study is to investigate the feasibility and acceptability of the internet Attachment-based compassion Therapy (iABCT) to promote wellbeing and mental health for the general population. A secondary aim is to explore the preliminary efficacy of iABCT at post-intervention and 3-month follow-up.

The principal hypothesis is that the iABCT will be feasible and well-accepted by participants in terms of expectations, satisfaction, usability, opinion, and cost-effectiveness. Moreover, it is expected that the iABCT will be effective to promote changes in self-reported measures of compassion, self-compassion, mindfulness, self-criticizing, attachment, wellbeing, and mental health. It is also hypothesized that gains will be maintained at 3-month follow-up.

A minimum of 35 participants is considered enough to cover the aims of this feasibility study and to provide precise and efficient estimations of parameters (i.e., means, standard deviations, effect size, and confidence intervals) for powering a larger randomized controlled trial (RCT).

Eligibility criteria: Inclusion Criteria:

* Be 18 years old or over.
* Have adequate knowledge to understand and read Spanish.
* Have a computer with speakers and Internet access in a secure setting (home or private office).
* Have an email account.
* Ability to use a computer and to surf the Internet.

Exclusion Criteria:

* Diagnosis of mental disorder according to the Diagnostic and Statistical Manual for Mental Health Disorders-Version 5 (DSM-5).
* Abuse or dependence on alcohol or other substances.
* Be receiving psychiatric or psychological treatment,
* Be engaged in ongoing formal meditation training (e.g., mindfulness or compassion intervention).
* Presence of heart disease, cardiorespiratory illness, or other severe medical condition.
* History of epileptic crisis.
* Unavailability to complete the online intervention because of operation or medical intervention.

Primary outcomes:
measure: Changes in Pemberton Happiness Index (PHI) (Hervás & Vázquez, 201)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
Secondary outcomes:
measure: Changes in Self-Compassion Scale (SCS-26) (Neff, 2003; García-Campayo et al., 2014)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Compassion Scale (Pommier, 2000)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form (FSCRS-SF) (Sommers-Spijkerman et al., 2017)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Five Facets of Mindfulness Questionnaire (FFMQ-15)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Relationships Questionnaire (RQ) (Bartholomew y Horowitz, 1991; Alonso-Arbiol y S.Yárnoz-Yaben, 2000).
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in General Health Questionnaire (GHQ-12) (Rocha et al., 2011)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Non-Attachment Scale (NAS-7) (Feliu et al., 2016; Sahdra et al. 2015)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; Thompson, 2007)
timeFrame: Before the intervention, during the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Purpose-In-Life Test (PIL-10) (García-Alandete, Rosa, y Sellés, 2013; García-Galante, 2014)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Changes in Compassion Practice Quality Questionnaire(12 ítems) (adapted from Del Re et al., 2015).
timeFrame: During the intervention, immediately after the intervention, and 3-month follow-up after the intervention
Other outcomes:
measure: Attrition rate
timeFrame: Immediately after the intervention, and 3-month follow-up after the intervention
measure: Expectations and satisfaction Questionnaire (Adapted from Borkovec y Nau, 1972)
timeFrame: Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention
measure: Acceptability and Usability Questionnaire (Labpsitec, 2019)
timeFrame: immediately after the intervention, and 3-month follow-up after the intervention
measure: Qualitative opinion interview
timeFrame: immediately after the intervention
Locations:
city: Zaragoza
country: Spain
facility: Centro de Salud Arrabal
Study officials:
affiliation: Universitat Jaume I. Instituto de Investigación Sanitaria Aragón (IIS Aragón).
name: Daniel Campos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: García-Campayo J, Demarzo M. Mindfulness y compasión. La nueva revolución. Barcelona: Siglantana; 2015.
citation: García-Campayo J, Navarro-Gil M, Demarzo M. Attachment-based compassion therapy. Mindfulness & Compassion. 2016;1:68-74. doi:10.1016/j.mincom.2016.10.004.
citation: Effects of Attachment-Based Compassion Therapy (ABCT) on Self-compassion and Attachment Style in Healthy People. Mindfulness
citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
citation: Krieger T, Martig DS, van den Brink E, Berger T. Working on self-compassion online: A proof of concept and feasibility study. Internet Interv. 2016 Oct 8;6:64-70. doi: 10.1016/j.invent.2016.10.001. eCollection 2016 Nov.
citation: Campos D, Navarro-Gil M, Herrera-Mercadal P, Martinez-Garcia L, Cebolla A, Borao L, Lopez-Del-Hoyo Y, Castilla D, Del Rio E, Garcia-Campayo J, Quero S. Feasibility of the Internet Attachment-Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial. JMIR Res Protoc. 2020 Aug 14;9(8):e16717. doi: 10.2196/16717.