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

NCT04809610 | Unknown

• 1 other identifier: UV-INV_ETICA-1564960
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Medical Illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Compassion and self-compassion

  Baseline (week 0), 3-month follow-up, 6-month follow-up

• Self-care and healthy behaviors

  Baseline (week 0), 3-month follow-up, 6-month follow-up

• Specific illness interference

  Baseline (week 0), 3-month follow-up, 6-month follow-up

• Self-criticism

  Baseline (week 0), 3-month follow-up, 6-month follow-up

• Symptomatology

  Baseline (week 0), 3-month follow-up, 6-month follow-up

Study Arms (2)

Intervention group: Internet attachment-based compassion therapy (iABCT).

EXPERIMENTAL

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).

Control group: Waiting list control group.

NO INTERVENTION

Participants in this condition will be informed that they will have access to the intervention at 3 months (after the intervention group).

Interventions

Internet attachment-based compassion therapy (iABCT). BEHAVIORAL

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.

Intervention group: Internet attachment-based compassion therapy (iABCT).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• ability to understand and read Spanish;
• access to a computer with the Internet; and
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

RECRUITING

Related Publications (18)

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  BACKGROUND

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  PMID: 23046287 BACKGROUND

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  BACKGROUND

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  PMID: 31992269 BACKGROUND

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  PMID: 31353931 BACKGROUND

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  PMID: 23607679 BACKGROUND

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  PMID: 31941418 BACKGROUND

• 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.

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  PMID: 17540143 BACKGROUND

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  PMID: 28341617 BACKGROUND

• 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.

  BACKGROUND

• 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.

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  BACKGROUND

• Martinez-Sanchis M, Vara MD, Herrero R, Campos D, Garcia-Campayo J, Banos RM. 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: A study protocol of a randomized controlled trial (SPIRIT compliant). PLoS One. 2022 Dec 27;17(12):e0278462. doi: 10.1371/journal.pone.0278462. eCollection 2022.

  PMID: 36574408 DERIVED

Central Study Contacts

Maria Angeles Matinez Sanchis

CONTACT

+34963864412; maria.a.martinez-sanchis@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: July 8, 2021
• Primary Completion: June 22, 2022
• Study Completion: February 22, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)