NCT03918746

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

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

April 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

April 11, 2019

Last Update Submit

June 10, 2021

Conditions

Keywords

compassioninternet-based Interventionsfeasibilitymeditationattachment

Outcome Measures

Primary Outcomes (1)

  • Changes in Pemberton Happiness Index (PHI) (Hervás & Vázquez, 201)

    PHI is a measure of well-being that contains 11 items (in a scale from 0 to 10 point) related to different domains of remembered wellbeing, and 10 items related to experienced well-being (i.e., 5 positive and 5 negative emotional events that might have happened the day before) (answering YES/NO). The sum of these items produces a combined well-being index ranging from 0 to 10. Higher values represent higher wellbeing.

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

Secondary Outcomes (10)

  • Changes in Self-Compassion Scale (SCS-26) (Neff, 2003; García-Campayo et al., 2014)

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

  • Changes in Compassion Scale (Pommier, 2000)

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

  • Changes in Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form (FSCRS-SF) (Sommers-Spijkerman et al., 2017)

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

  • Changes in Five Facets of Mindfulness Questionnaire (FFMQ-15)

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

  • Changes in Relationships Questionnaire (RQ) (Bartholomew y Horowitz, 1991; Alonso-Arbiol y S.Yárnoz-Yaben, 2000).

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

  • +5 more secondary outcomes

Other Outcomes (4)

  • Attrition rate

    Immediately after the intervention, and 3-month follow-up after the intervention

  • Expectations and satisfaction Questionnaire (Adapted from Borkovec y Nau, 1972)

    Before the intervention, immediately after the intervention, and 3-month follow-up after the intervention

  • Acceptability and Usability Questionnaire (Labpsitec, 2019)

    immediately after the intervention, and 3-month follow-up after the intervention

  • +1 more other outcomes

Study Arms (1)

internet Attachment-Based Compassion Therapy (iABCT)

EXPERIMENTAL

The intervention will consist of an internet version of Attachment-Based Compassion Therapy (iABCT). The length of the intervention will depend on the pace of each participant that will be advised to carry out one module per week, taking days between sessions to complete homework assignments. It is estimated that the online intervention can be completed in eight weeks, with a maximum period of ten weeks. However, each participant will be free to advance at his/her own pace. Formal telephone support will be not systematically provided, but participants will contact for technical assistance (i.e., web accessibility problems or forgotten password) if necessary.

Behavioral: internet Attachment-Based Compassion Therapy (iABCT)

Interventions

The internet version of Attachment-Based Compassion Therapy (iABCT) will be developed to be totally self-applied over the Internet through the website www.psicologiaytecnologia.com designed by Labpsitec (Laboratory of Psychology and Technology, Universitat Jaume I, and University of Valencia). The iABCT will consist of eight sequential modules: Module 0) Welcome module: approaching to the compassion; Module 1) Preparing ourselves for compassion. Kind attention; Module 2) Discovering our compassionate world; Module 3) Developing our compassionate world; Module 4) Understanding our relationship with compassion; Module 5) Working on ourselves; Module 6) Understanding the importance of forgiveness; Module 7) Consolidating the practice of compassion The content will present through texts, audios, videos, pictures, vignettes, and interactive exercises. Downloadable PDF files will be available so that users can review them offline.

internet Attachment-Based Compassion Therapy (iABCT)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Salud Arrabal

Zaragoza, 50015, Spain

Location

Related Publications (6)

  • García-Campayo J, Demarzo M. Mindfulness y compasión. La nueva revolución. Barcelona: Siglantana; 2015.

    BACKGROUND
  • 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.

    BACKGROUND
  • Effects of Attachment-Based Compassion Therapy (ABCT) on Self-compassion and Attachment Style in Healthy People. Mindfulness

    BACKGROUND
  • 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.

    PMID: 27965879BACKGROUND
  • 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.

    PMID: 30135815BACKGROUND
  • 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.

Related Links

Study Officials

  • Daniel Campos, PhD

    Universitat Jaume I. Instituto de Investigación Sanitaria Aragón (IIS Aragón).

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 17, 2019

Study Start

February 20, 2020

Primary Completion

October 1, 2020

Study Completion

May 1, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

The raw IPD will be made available by the authors, without undue reservation, to any qualified researcher. Dataset will be available through scientific repositories and via email request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
When the study is finished and results published.
Access Criteria
The raw IPD will be made available by the authors, without undue reservation, to any qualified researcher.

Locations