Clinical trial NCT04809610: Efficacy of Attachment-based Compassion Therapy in Population With Chronic Medical Illness (CUIDA-TEC)
Official title: Effectiveness of the Internet Attachment-Based Compassion Therapy (iABCT) to Improve the Quality of Life and Well-being in a Population With Chronic Medical Illness.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Medical Illness
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compassion-Based Interventions are increasingly relevant as a potentially beneficial way to support people with chronic medical conditions and improve different outcomes related with the management of the disease. Online interventions The purpose of this study is to evaluate the effectiveness of the internet version of the attachment-based compassion therapy for improving quality of life in a population with chronic medical illness.

Detailed description: Our participants will be randomized to one of the following two conditions: 1) the Internet version of the attachment-based compassion therapy, and 2) Waiting list (WL) control group.

The corresponding evaluations of the outcomes will be carried out at different moments of the process: baseline, and a three- and six-month follow-up.

This study will use the internet version of attachment-based compassion therapy (iABCT) for improving the quality of life in a population with chronic medical illness.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years;
2. ability to understand and read Spanish;
3. access to a computer with the Internet; and
4. fulfill criteria for diagnosis of one of the following chronic medical conditions: diabetes, inflammatory bowel disease, fibromyalgia, low-back chronic pain, migraines, and other conditions.

Exclusion Criteria:

1. Terminal disease;
2. severe psychiatric disorders comorbidities (schizophrenia, substance dependence, bipolar disorder, psychotic illness) or severe neurologic or medical condition; and
3. receiving psychological treatment or mindfulness training at the time of recruitment.

Primary outcomes:
measure: Changes in quality of life
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Changes in wellbeing
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Compassion and self-compassion
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Self-care and healthy behaviors
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Specific illness interference
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Self-criticism
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Symptomatology
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Attachmetn styles
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Social support
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Illness perception
timeFrame: Baseline (week 0), 3-month follow-up, 6-month follow-up
measure: Client's satisfaction
timeFrame: 3-month follow up (only intervention group), 6-month follow-up (only WL control group)
measure: Difficulties of the compassion practice
timeFrame: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
measure: Usability and client acceptance
timeFrame: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
measure: Semi-structured qualitative interview
timeFrame: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References:
citation: Austin J, Drossaert CHC, Schroevers MJ, Sanderman R, Kirby JN, Bohlmeijer ET. Compassion-based interventions for people with long-term physical conditions: a mixed methods systematic review. Psychol Health. 2021 Jan;36(1):16-42. doi: 10.1080/08870446.2019.1699090. Epub 2020 Mar 2.
citation: Badia X, Roset M, Montserrat S, Herdman M, Segura A. [The Spanish version of EuroQol: a description and its applications. European Quality of Life scale]. Med Clin (Barc). 1999;112 Suppl 1:79-85. Spanish.
citation: Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
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.
citation: Cook-Cottone, C. P., & Guyker, W. M. (2018). The development and validation of the Mindful Self-Care Scale (MSCS): An assessment of practices that support positive embodiment. Mindfulness, 9(1), 161-175.
citation: Del Re AC, Fluckiger C, Goldberg SB, Hoyt WT. Monitoring mindfulness practice quality: an important consideration in mindfulness practice. Psychother Res. 2013;23(1):54-66. doi: 10.1080/10503307.2012.729275. Epub 2012 Oct 9.
citation: Fonseca-Pedrero, E., Paino, M., Lemos-Giráldez, S., & Muñiz, J. (2010). Propiedades psicométricas de la depression anxiety and stress scales-21 (DASS-21) en universitarios españoles. Ansiedad y Estrés, 16.
citation: Finlay-Jones A, Boyes M, Perry Y, Sirois F, Lee R, Rees C. Online self-compassion training to improve the wellbeing of youth with chronic medical conditions: protocol for a randomised control trial. BMC Public Health. 2020 Jan 28;20(1):106. doi: 10.1186/s12889-020-8226-7.
citation: Gu J, Baer R, Cavanagh K, Kuyken W, Strauss C. Development and Psychometric Properties of the Sussex-Oxford Compassion Scales (SOCS). Assessment. 2020 Jan;27(1):3-20. doi: 10.1177/1073191119860911. Epub 2019 Jul 29.
citation: Hervas G, Vazquez C. Construction and validation of a measure of integrative well-being in seven languages: the Pemberton Happiness Index. Health Qual Life Outcomes. 2013 Apr 22;11:66. doi: 10.1186/1477-7525-11-66.
citation: Irani E, Niyomyart A, Hickman RL Jr. Systematic Review of Technology-Based Interventions Targeting Chronically Ill Adults and Their Caregivers. West J Nurs Res. 2020 Nov;42(11):974-992. doi: 10.1177/0193945919897011. Epub 2020 Jan 16.
citation: Pacheco-Huergo V, Viladrich C, Pujol-Ribera E, Cabezas-Pena C, Nunez M, Roura-Olmeda P, Amado-Guirado E, Nunez E, Del Val JL; en representacion del Grupo IPQ-R. [Perception in chronic illnesses: linguistic validation of the revised Illness Perception Questionnaire and the Brief Illness Perception Questionnaire for a Spanish population]. Aten Primaria. 2012 May;44(5):280-7. doi: 10.1016/j.aprim.2010.11.022. Epub 2011 Sep 28. Spanish.
citation: Costa Requena G, Salamero M, Gil F. [Validity of the questionnaire MOS-SSS of social support in neoplastic patients]. Med Clin (Barc). 2007 May 12;128(18):687-91. doi: 10.1157/13102357. Spanish.
citation: Rogers MA, Lemmen K, Kramer R, Mann J, Chopra V. Internet-Delivered Health Interventions That Work: Systematic Review of Meta-Analyses and Evaluation of Website Availability. J Med Internet Res. 2017 Mar 24;19(3):e90. doi: 10.2196/jmir.7111.
citation: Sirois, F. M., Molnar, D. S., & Hirsch, J. K. (2015). Self-compassion, stress, and coping in the context of chronic illness. Self and Identity, 14(3), 334-347.
citation: Smart LM, Peters JR, Baer RA. Development and Validation of a Measure of Self-Critical Rumination. Assessment. 2016 Jun;23(3):321-32. doi: 10.1177/1073191115573300. Epub 2015 Feb 23.
citation: Yárnoz-Yaben, S., & Comino, P. (2011). Evaluación del apego adulto: análisis de la convergencia entre diferentes instrumentos. Acción psicológica, 8(2), 67-85.