Efficacy of Attachment-based Compassion Therapy in Population With Chronic Medical Illness (CUIDA-TEC) (CUIDA-TEC)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Medical Illness
• Intervention / Treatment: Behavioral: Internet attachment-based compassion therapy (iABCT).

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • University of Valencia
    • Contact: Rosa Maria Baños Rivera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: Internet attachment-based compassion therapy (iABCT).; The iABCT is a self-applied program based on the attachment theory and the use of compassion meditations. It is composed of 8 modules that have been reformulated to be completely self-applied and include text, images, illustrations, videos, audio with guided meditations, exercises, and homework. Downloadable PDF files will be made available so that users can review them offline. Each module has been optimized to have a duration of 60 and 90 minutes approximately. The entire intervention is estimated to be completed in eight weeks.	Behavioral: Internet attachment-based compassion therapy (iABCT).; The iABCT is a self-applied program based on the attachment theory and the use of compassion meditations. It is composed of 8 modules that have been reformulated to be completely self-applied and include text, images, illustrations, videos, audio with guided meditations, exercises and homework. Downloadable PDF files will be made available so that users can review them offline. Each module has been optimized to have a duration of 60 and 90 minutes approximately. The entire intervention is estimated to be completed in eight weeks.
No Intervention: Control group: Waiting list control group.; Participants in this condition will be informed that they will have access to the intervention at 3 months (after the intervention group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life	EuroQol (EQ-5D; Badia et al., 1999). It is a self-report measures composed by five dimensions of functionality in daily-life and three levels of severity (1-3). A higher score in this scale indicates higher severity on the different areas of functioning in daily life.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Changes in wellbeing	Pemberton Happiness Index (PHI; Hervás and Vázquez, 2013). The scale includes eleven items related to different domains of remembered well-being (general, hedonic, eudaimonic, and social well-being) and ten items related to experienced well-being (i.e., positive and negative emotional events that possibly happened the day before); the sum of these items produces a combined well-being index that range from 0 to 10. Higher levels indicate higher levels of wellbeing.	Baseline (week 0), 3-month follow-up, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compassion and self-compassion	Sussex-Oxford Compassion for the Self Scale (SOCS; Gu et al.,, 2020). This scale asses levels of compassion and self-compassion in a 5-point likert scale. Higher scores indicate higher levels of compassion and self-compassion.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Self-care and healthy behaviors	Mindful Self-Care Scale - Brief version (B-MSC; Cook-Cottone, 2018). It is a 24-item scale that measures the frequency of self-care behaviors. The scale addresses 6 domains of self-care: mindful relaxation, physical care, self-compassion and purpose, supportive relationships, supportive structure, and mindfulness. Higher punctuation means a higher frequency of self-care behaviors.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Specific illness interference	Specific questionnaires will be used to assess specific illness interferences for the different medical conditions included in the study: the Diabetes Distress Scale (DDS; Martin et al., 2007) for participants with type I and type II diabetes; the Roland-Morris Questionnaire (Kovacs et al., 2002) for participants with low-back chronic pain; the Revised Fibromyalgia Impact Questionnaire (FIQR; Salgueiro et al., 2013) for participants with fibromyalgia; the Migraine Disability Assessment questionnaire (MIDAS; Rodríguez-Almagro et al., 2020) for participants with migraines; and the Inflammatory Bowel Disease Questionnaire (IBDQ-32; Masachs et al., 2007) for participants with inflammatory bowel illness.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Self-criticism	Self-critical rumination Scale (SCRS; Smart et al., 2016). A 10-item questionnaire measuring self-criticism is defined as a form of negative thinking that devalues the self. It assesses thoughts that criticize the self for perceived errors, failures, weaknesses, defects, bad habits or general inadequacy. It takes into account the ruminative qualities of thought: frequency, duration, repetition, and difficulty of control. Final scores range from 10 to 40 and higher scores indicate a higher level of self-criticism.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Symptomatology	The Depression, Anxiety and Stress Scale (DASS-21; Fonseca-Pedrero et al., 2010). This scale is an abbreviated form of the DASS questionnaire containing 21 items organized in three subscales to assess anxiety, depression, and stress symptomatology. Each subscale has 7 items that range from 0 to 3 points. Higher scores indicate higher levels of symptomatology.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Attachmetn styles	The Relationships Questionnaire (RQ; Yárnoz-Yaben and Comino, 2011). This is a 4-item questionnaire designed to measure adult attachment style. The RQ consists of four paragraphs, each describing an attitude toward relationships in general. The participant rates each paragraph on a scale of 1 (does not describe me at all) to 7 (describes me exactly).	Baseline (week 0), 3-month follow-up, 6-month follow-up
Social support	Medical Outcomes Study-Social Support Survey (MOS; Requena et al., 2007). A 20-item questionnaire that analyzes the perception of help and social support. Item 1 refers to the size of the social network and the remaining 19 items measure four dimensions of functional social support: emotional (8 items), instrumental (4 items), positive social interaction (4 items), and affective support (3 items). The items present a 5-point response scale that measures progressively (from never to always) how often each type of social support is available to the caregiver. A total score can also be obtained, where higher scores would indicate more support received.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Illness perception	Illness perception questionnaire - revised (IPQ-R; Pacheco-Huergo et al., 2012). The Illness Perception Questionnaire-Revised was designed to assess the cognitive and emotional dimensions of illness representations. The IPQ-R consists of three sections. Two scales measure the identity and causal dimensions and another section assesses the dimensions of duration (acute/chronic), cyclical course, consequences, personal control, treatment control, coherence, and emotional representations.	Baseline (week 0), 3-month follow-up, 6-month follow-up
Client's satisfaction	Expectancy and satisfaction questionnaire (adapted from Borkovec and Nau, 1972). A 6-item questionnaire that measures credibility towards treatment and patients' expectations of improvement. Higher score indicates higher levels of client credibility and expectation of improvement.	3-month follow up (only intervention group), 6-month follow-up (only WL control group)
Difficulties of the compassion practice	The Compassion Practice Quality Scale (CPQS) (Navarrete et al., 2021) has been developed to assess the key aspects of compassion practices (e.g., mental imagery, sense of connection and warmth, compassionate phrases, and compassionate gestures). This self-reported questionnaire includes 10 items that participants score on a scale ranging from 0 to 100 indicating the percentage of the time that their experience reflects each statement. Higher scores indicate higher quality of practice (i.e., less practice difficulties).	3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Usability and client acceptance	System Usability Scale (SUS; adapted from Campos et al., 2020). The System Usability Scale (SUS) provides a reliable tool for measuring the usability of a program. It consists of a 10 item questionnaire with a 5-point likert scale. Higher scores indicate higher levels of usability and client acceptance of the program.	3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Semi-structured qualitative interview	An Ad-hoc instrument with open questions created to assess participants' opinions about the program and the support received. Adapted from Campos et al. 2018.	3-month follow-up (only intervention group), 6-month follow-up (only WL control group)

Collaborators and Investigators

• Sponsor: University of Valencia

Publications and helpful links

General Publications

• 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.
• Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Yárnoz-Yaben, S., & Comino, P. (2011). Evaluación del apego adulto: análisis de la convergencia entre diferentes instrumentos. Acción psicológica, 8(2), 67-85.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Anticipated): June 22, 2022
• Study Completion (Anticipated): February 22, 2023

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UV-INV_ETICA-1564960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No