Chronic Medical IllnessCUIDA-TECNCT04809610
Efficacy of Attachment-based Compassion Therapy in Population With Chronic Medical Illness (CUIDA-TEC)
A study testing Internet attachment-based compassion therapy (iABCT). in people with Chronic Medical Illness, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Medical Illness
- What is being tested?
- Internet attachment-based compassion therapy (iABCT).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jul 2021to 22 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Valencia
Valencia, 46010
Rosa Maria Baños Rivera
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Medical Illness
- Being tested
- Internet attachment-based compassion therapy (iABCT).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet attachment-based compassion therapy (iABCT).Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (week 0), 3-month follow-up, 6-month follow-up
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start8 Jul 2021
- Primary completion22 Jun 2022 (estimated)
- Study completion22 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Medical IllnessStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809610
- Sponsor's protocol ID
- UV-INV_ETICA-1564960
- Acronym
- CUIDA-TEC
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32116052Badia 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.
PubMed 10618804Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
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.
PubMed 32384051Cook-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.
PubMed 23046287Fonseca-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.
PubMed 31992269Gu 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.
PubMed 31353931Hervas 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.
PubMed 23607679Irani 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.
PubMed 31941418Pacheco-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.
PubMed 21955598Costa 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.
PubMed 17540143Rogers 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.
PubMed 28341617Sirois, 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04809610
- Acronym / sponsor ID
- CUIDA-TEC / UV-INV_ETICA-1564960
- Conditions
- Chronic Medical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 22 Jun 2022 (estimated)
- Study completion
- 22 Feb 2023 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Internet attachment-based compassion therapy (iABCT). | Experimental | 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group: Internet attachment-based compassion therapy (iABCT). |
Primary outcome
Changes in quality of life
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
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.
Changes in wellbeing
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
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.
12 secondary outcomes
Compassion and self-compassion
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Self-care and healthy behaviors
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Specific illness interference
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Self-criticism
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Symptomatology
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Attachmetn styles
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Social support
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Illness perception
Time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up
Client's satisfaction
Time frame: 3-month follow up (only intervention group), 6-month follow-up (only WL control group)
Difficulties of the compassion practice
Time frame: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Usability and client acceptance
Time frame: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Semi-structured qualitative interview
Time frame: 3-month follow-up (only intervention group), 6-month follow-up (only WL control group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 32116052Austin 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.
- Background: PubMed 10618804Badia 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.
- BackgroundBorkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
- Background: PubMed 32384051Campos 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.
- BackgroundCook-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.
- Background: PubMed 23046287Del 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.
- BackgroundFonseca-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.
- Background: PubMed 31992269Finlay-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.
- Background: PubMed 31353931Gu 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.
- Background: PubMed 23607679Hervas 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.
- Background: PubMed 31941418Irani 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.
- Background: PubMed 21955598Pacheco-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet attachment-based compassion therapy (iABCT). in people with Chronic Medical Illness, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Angeles Matinez Sanchis (+34963864412, maria.a.martinez-sanchis@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (time frame: Baseline (week 0), 3-month follow-up, 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809610, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.