CompassionNCT04512092
The Efficacy of a Compassionate Mind Training Program With Caregivers of Residential Youth Care
A study testing Compassionate Mind Training for Caregivers in people with Compassion, run by University of Coimbra at 1 site in Portugal.
Trial summary
This clinical trial aims to improve the quality of the care provided in residential youth care, through a Compassionate Mind Training (CMT-C) program targeted to caregivers. The promotion of an affiliative mentality of caring, warmth and affection in the residential care setting is operationalized through the… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compassion
- What is being tested?
- Compassionate Mind Training for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2019to 30 Jan 2022
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Eligibility criteria for clusters:
Inclusion criteria: Residential care homes (RCH) in the Centre region of Portugal, receiving adolescents (both genders) aged between 12 and 25 YO.
Exclusion criteria: RCH mostly receiving children or specialized in mental and behavioural disorders/substance abuse problems will be excluded (to control for mental health treatments delivered in these RCH).
Eligibility criteria for participants:
Inclusion criteria for caregivers: Professionals working in RCH and directly interacting with the adolescents on a regular basis.
Inclusion criteria for adolescents: have entered in the RCH at least 1-month before the study's onset (adjustment time); aged between 12 and 25 YO.
Exclusion criteria for adolescents: cognitive impairment; remaining in residential care for less than 9 months.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Psychology and Educational Sciencies, University of Coimbra
Coimbra, 3001-802
About this study
Official title: Affiliative Mentality in Residential Youth Care: A Cluster Randomized Trial of a Compassionate Mind Training Program With Caregivers
This clinical trial aims to improve the quality of the care provided in residential youth care, through a Compassionate Mind Training (CMT-C) program targeted to caregivers. The promotion of an affiliative mentality of caring, warmth and affection in the residential care setting is operationalized through the development of a compassionate-self and compassionate care skills. A cluster randomized trial with a control group was carried out in order to test the efficacy of a 12-session Compassionate Mind Training Program to caregivers of residential youth care in increasing compassion, self-compassion, social safeness, emotional climate, empathy, emotion regulation, satisfaction with life, and resiliency and in reducing self-criticism, fears of compassion as well as stress, burnout, anxiety and depression. Youths in residential care were also assessed as informants, thought self-reported questionnaires on current experiences of warmth and safeness, social safeness, emotional climate, positive and negative affect. The organizational impact was assessed via focus groups. It is hypothesized that the CMT-C would produce significant improvements in outcome measures, when comparing caregivers who receive the CMT-C with those in the control group. It is expected that after the training, caregivers will present a greater sensibility to their own and others suffering and motivation to relieve it, exhibiting and experiencing empathic responses. Consequently, it is also expected that youths in care perceive more warmth and safeness experiences with caregivers and a more secure and safe emotional climate in the residential care home.
Read the detailed description
This was a Cluster Randomized Trial with a control group carried out in twelve Portuguese Residential Youth Care facilities. It aimed to test the efficacy of a group-based Compassionate Mind Training program (CMT-C) targeted to caregivers, in promoting significant changes both in caregivers and adolescents in residential youth care. This trial was carried out in accordance with the ethical principles of the Declaration of Helsinki and the applicable national laws and regulations. The ethics committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra approved the study's procedures.
Since CMT-C is targeted for residential care homes' (RCH) teams, for practical reasons (to maximize time and human resources) and to avoid contamination, the unit of randomization was the RCH (i.e., cluster), hence a cluster randomized design was followed according CONSORT guidelines. From the 32 RCH within the Centre region of Portugal, 19 RCH obeying to cluster eligibility criteria were invited to participate. Twelve RCH agreed to enter the trial. Their caregivers and adolescents, who were eligible for the study, were informed of the goals and procedures of this research, and invited to voluntarily participate. No incentives were offered for participation. Written informed consent were sought at the cluster level (from the board of each RCH), and at the individual level to caregivers and adolescents (and their legal guardians), before the randomization occurred. Adolescents aged between 14 and 16 YO, gave informed assent, while the older than 16 YO will give written informed consent. A written informed consent was also gathered from guardians/legal representatives of all adolescent participants under 18 YO. The anonymity of all participants responses was guaranteed, with the use of respondent-specific codes, which were also used to link the data from one time point to the other. Data was collectively collected in each RCH with the presence of an independent researcher, in order to answer any questions and ensure confidentiality. All participants (caregivers and adolescents) were assessed through self-report measures 5 times across 12 months. Specifically, participants were assessed 3 months before the beginning of the CMT-C (Baseline 0 - time 0), before the first session of the program (baseline 1 - time 1), right after its terminus (i.e., post-treatment assessment - time 2), and 3 and 6 months after intervention terminus (follow-up 1 and 2 - time 3 and time 4). Participants in the control group were assessed with the same time intervals as those in intervention group.
After the first baseline assessment, a computer-generated randomization was conducted at the cluster level, following a completely randomized design. Each RCH (i.e., cluster) was randomly assigned to one of two conditions: CMT-C and control group. Six RCH were allocated in the experimental group and received the TMC for caregivers, the remaining 6 constituted the control group. Caregivers in the treatment group attended the CMT-C for about 12 weeks. The CMT-C consisted of twelve, 2.5-hr weekly group sessions, delivered in each RCH to a group of 7 to 10 participants. Caregivers in the control group did not received any mind training or group intervention.
After post-treatment assessments, focus groups were carried out with the caregivers allocated in the CMT-C group, in order to enrich understanding about the participants' experience with the intervention and their perception of change at 3 different levels (individual, interindividual and organizational).
Treatment integrity were ensured through: a) specific treatment manuals; b) direct training of the therapist; c) supervision; and d) assessment of adherence and competence through an integrity rating scale.
Treatment effects will be analyzed following an intention-to-treat analysis using Latent Growth Curve Models (LGCM). The intercept (i.e., initial status) and slope (i.e., change over time) will be modeled as latent variables from longitudinal data (T0 to T4). Per-protocol analysis will also be carried out to investigate treatment effects in completers. Moderator (e.g., clusters) effects will also be tested with Conditional LGCM, and will be included as predictors of change over time in the outcome measures. Nested qualitative evaluation with thematic analysis will be carried out after the last follow-up.
- Conditions
- Compassion
- Being tested
- Compassionate Mind Training for Caregivers
- Keywords
- Residential Care, Compassionate Mind Training, Caregivers, Children and adolescents at risk, Compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassionate Mind Training for CaregiversBehavioural
CMT-C is a 12-session group program, each lasting about 2,5 hours, which run on a weekly basis. The program is organized across 3 modules: 1) Our mind according to a compassion-based approach (to provide insight into the evolved and socially shaped mind and the affect regulation systems); 2) Compassionate mind training (understanding and cultivating the attributes and competencies of compassion in its three flows, and addressing its fears); and 3) final session (revising key information and practices and its application to the RCH practices/routines). Its sessions have the following structure: 1) Check-in (grounding exercise, reviewing the previous session, sharing the weekly practice); 2) Exploration of the session theme (psychoeducation and experiential practices followed by group opportunities for share experiences and discussion); 3) Check-out (session summary and application to the self, youths and RCH practices, weekly practice challenge, session evaluation, session take-off).
| Study group | Role | What they receive |
|---|---|---|
| CMT-C group | Experimental | Compassion Mind Training for Caregivers (CMT-C) is a 12-session structured program to be delivered in a group format, aiming to cultivate a compassionate-self and compassionate care practices in residential youth care. Receives: Behavioral: Compassionate Mind Training for Caregivers |
| Control group | No intervention | This group did not receive any mind training or group intervention during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Compassion
Caregivers reported on the Compassion Scale (CS; Pommier, 2011; Portuguese version by Sousa, Castilho, Vieira, Vagos, \& Rijo, 2017). The CS is a 24-item self-report scale that measures compassion for others. Participants answered each item according to how frequently they feel and act towards others, using a 5-point Likert scale (1 = almost never, to 5 = almost always). In the Portuguese version, a CFA revealed the existence of six subscales and two higher-order factors: Compassion (comprising the positive subscales: Kindness, Common Humanity, Mindfulness) and Disconnectedness (comprising the negative subscales: Indifference, Separation and Disengagement), which represent a positive and a negative valence of compassion.
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Change of Self-Compassion
Caregivers reported on the Self-Compassion Scale (SCS; Neff, 2003; Portuguese version by Castilho, Pinto-Gouveia \& Duarte, 2015). The SCS is a 26 self-reported scale which addresses self-compassion and instructs participants to answer its items, rated in a 5-point Likert scale (1 = almost never, to 5 = almost always), regarding "how I typically act towards myself in difficult times". In the original version, the scale has a total score and six subscales (Self-Kindness; Self-Judgement; Common Humanity; Isolation; Mindfulness; and Over-Identification). The Portuguese version tested a two-factor model, finding that a Self-Compassionate attitude (comprising the positive subscales: Self-Kindness, Common Humanity, Mindfulness) and Self-Critical attitude (comprising the negative subscales: Self-Judgement, Isolation and Over-Identification).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Change of Fears of Compassion
Caregivers reported on the Fears of Compassion Scales (FCS; Gilbert, McEwan, Matos, \& Rivis, 2011; Portuguese version by Matos, Pinto-Gouveia, Duarte, \& Simões, 2011). The FCS integrates three self-reported scales designed to assess fears of being compassionate toward others (10 items), receiving compassion from others (13 items) and being self-compassionate (15 items). The items were rated on a 5-point Likert scale (0 = Do not agree at all, to 4 = Completely agree).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Change of Social Safeness
Caregivers reported on the Social Safeness and Pleasure Scale (SSPS; Gilbert et al., 2009; Portuguese version by Dinis, Castilho, Xavier, \& Pinto-Gouveia, 2008). The SSPS is an 11-item unidimensional self-reported scale that assesses the frequency with which individuals experience positive feelings in their social relationships, as well as, they experience the world as a safe and soothing place. Items are rated through a 5-point Likert scale (1 =almost never, to 5=almost always).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Change of Emotional Climate at the workplace
Caregivers reported on the Emotional Climate in Organizations Scale Adults (ECOS-A; Albuquerque et al., 2018). The ECOS-A is a 30-item self-report scale, aiming to assess how workers felt and behaved at their workplace, over the past two weeks. This scale has two parts (i.e., emotions and motives) with 15 items each. Each one is divided into 3 subscales, with 5 items, referring to the three affect's regulation systems: the threat system, the soothing system and the drive system. All items are answered according to a 5-points Likert's scale (0 =Never, to 4= Always).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Secondary outcomes (11)
Emotion regulation
Caregivers reported on the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij, \& Spinhoven, 2002; Portuguese version by Castro et al., 2013). CERQ is a 36 items self-report questionnaire designed to measure specific cognitive emotion regulation used in response to the experience of threatening or stressful events. It has nine subscales, each one corresponding to one cognitive emotion regulation strategy: Self-Blame (SB), Rumination (R), Positive Refocusing (PRF), Planning (P), Other-Blame (OB), Catastrophizing (C), Putting into Perspective (PIP), Positive Reappraisal (PRP) and Acceptance (A). Each subscale has 4 items, answered on a five-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Mental Health Symptoms
Caregivers reported on the Depression, Anxiety and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995; Portuguese version by Pais-Ribeiro, Honrado \& Leal, 2004). DASS-21 is a 21 items self-report measure designed to assess three dimensions of psychopathological symptoms: depression, anxiety, and stress. Items are rated using a four-point Likert scale for frequency (ranging from 0=Does not apply to me at all to 3 =Applied to me very much or most of the time).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Professional Quality of Life
Caregivers reported on the Professional Quality of Life Scale, version 5 (ProQOL-5; Stamm, 2010; Portuguese version by Carvalho, 2011). The ProQOL is a 30-item self-report measure composed by three subscales: compassion satisfaction (CS), burnout (BO) and secondary traumatic stress (STS). Participants are instructed to indicate how frequently each item was experienced in the previous 30 days, on a 5-point Likert scale (from 1 = never to 5 = very often).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Empathy
Caregivers reported on the Interpersonal Reactivity Index (IRI; Davis, 1983; Portuguese version by Limpo, Alves \& Castro, 2010). IRI is a 24-item self-reported scale, aiming to measure perspective taking, empathic concern and fantasy. Perspective taking is considered a cognitive component of empathy, while empathic concern and personal distress are considered the affective component. Respondents are instructed to rate how well each statement describes them on a 5- point Likert scale (from 0 = not well to 4 = very well).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Resilience
Caregivers reported on the Resilience Scale (RS; Wagnild \& Young, 1993; Portuguese version by Pinheiro \& Matos, 2013). RS is a 14-item self-reported scale aiming to assess resiliency. Respondents are instructed to rate how well each statement describes them on a 7- point Likert scale (from 1 = Completely disagree, to 7 = Completely agree).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Satisfaction with life
Caregivers reported on the Satisfaction With Life Scale (SWLS; Diener, Emmons, Larsen, \& Griffin, 1985; Portuguese version by Simões, 1992) SWLS is a 5-item scale that measures the cognitive-judgmental aspects of general life satisfaction. Each item is scored from 1 to 7 on a Likert-type scale ranging from strongly disagree to strongly agree.
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Positive and negative affect
Caregivers and adolescents reported on the Positive and Negative Affect Schedule (PANAS; Watson et al., 1988; Portuguese version for adolescents by Galinha \& Pais-Ribeiro, 2005). PANAS is a 20-item self-report scale designed to assess two mood states: positive affect and negative affect. Each subscale is composed by 10 items, that describe feelings and emotions. Participants are asked to rate the severity and frequency of these feelings and emotions in the last few weeks, using a 5-point Likert scale (1=nothing or very slightly, to 5=extremely).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Warmth and Safeness experiences
Adolescents reported on the Current Experiences of warmth and safeness (CEWSS-A) (Santos, Sousa, Pinheiro \& Rijo, 2020). The CEWSS-A is a 12-items self-report measure designed to assess the frequency in which adolescents feel emotional experiences of warmth, care, safeness with others, in the time period of the last two weeks. Items are answered using a Likert-scale response ranging from 0 (No, never) to 4 (Yes, most of the time).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Social safeness
Adolescents reported on the Social Safeness and Pleasure Scale for Adolescents (SSPS-A; Gilbert et al., 2009; Portuguese version for adolescents by Castilho et al., 2015). The SSPS-A is an 11-item unidimensional self-reported scale that assesses the frequency with which individuals experience positive feelings in their social relationships, as well as, they experience the world as a safe and soothing place. Items are rated through a 5-point Likert scale (1 =almost never, to 5=almost always).
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Emotional Climate in Residential Care Home
Adolescents reported on the Emotional Climate in the Classroom Scale (ECCS; Albuquerque, Matos, Cunha, Galhardo, Palmeira, \& Lima, 2018). ECCS is a 15-item self-report scale aiming to assess how adolescents feel in classroom over the past two weeks. This scale is divided into 3 subscales, which one with 5 items, describing different feelings associated to the three affect's regulation systems: the threat system, the soothing system and the drive system. Items are answered according to a Likert's scale, ranging from 0 "Never" to 4 "Always".
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Internalizing and externalizing problems
Adolescents reported on the Strengths and Difficulties Questionnaire (SDQ; Goodman, Meltzer, \& Bailey, 1998; Portuguese version by Fleitlich et al., 2005). The self-report SDQ version has 25-items rated using a Likert-type response scale ranging from 0 (not true) to 2 (certainly true). It can be completed by young people aged 11-17 years and is organized into five subscales - emotional symptoms, conduct problems, hyperactivity/inattention difficulties, peer relationship problems and prosocial behaviors. SDQ bi-factor model - internalizing and externalizing has been extensively used.
Measured: baseline; 3 months; 6 months; 9 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 May 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CompassionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Laura Filipa Seiça Matias Santos, University of Coimbra
- Investigators
- Daniel Rijo, PhD, Study director, CINEICC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512092
- Sponsor's protocol ID
- SFRH/BD/132327/2017
- Other IDs
- SFRH/BD/132327/2017
- Status last verified
- Sep 2021
- First submitted
- 6 Aug 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Santos L, Pinheiro MDR, Rijo D. The Effects of the Compassionate Mind Training for Caregivers on Professional Quality of Life and Mental Health: Outcomes from a Cluster Randomized Trial in Residential Youth Care Settings. Child Youth Care Forum. 2023 May 3:1-21. doi: 10.1007/s10566-023-09749-6. Online ahead of print.
PubMed 37360762
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affiliative Mentality in Residential Youth Care: A Cluster Randomized Trial of a Compassionate Mind Training Program With Caregivers
- ClinicalTrials.gov ID
- NCT04512092
- Acronym / sponsor ID
- SFRH/BD/132327/2017
- Conditions
- Compassion
- Keywords
- Residential Care, Compassionate Mind Training, Caregivers, Children and adolescents at risk, Compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 13 Aug 2020 (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.
This clinical trial aims to improve the quality of the care provided in residential youth care, through a Compassionate Mind Training (CMT-C) program targeted to caregivers. The promotion of an affiliative mentality of caring, warmth and affection in the residential care setting is operationalized through the development of a compassionate-self and compassionate care skills. A cluster randomized trial with a control group was carried out in order to test the efficacy of a 12-session Compassionate Mind Training Program to caregivers of residential youth care in increasing compassion, self-compassion, social safeness, emotional climate, empathy, emotion regulation, satisfaction with life, and resiliency and in reducing self-criticism, fears of compassion as well as stress, burnout, anxiety and depression. Youths in residential care were also assessed as informants, thought self-reported questionnaires on current experiences of warmth and safeness, social safeness, emotional climate, positive and negative affect. The organizational impact was assessed via focus groups. It is hypothesized that the CMT-C would produce significant improvements in outcome measures, when comparing caregivers who receive the CMT-C with those in the control group. It is expected that after the training, caregivers will present a greater sensibility to their own and others suffering and motivation to relieve it, exhibiting and experiencing empathic responses. Consequently, it is also expected that youths in care perceive more warmth and safeness experiences with caregivers and a more secure and safe emotional climate in the residential care home.
Detailed description
This was a Cluster Randomized Trial with a control group carried out in twelve Portuguese Residential Youth Care facilities. It aimed to test the efficacy of a group-based Compassionate Mind Training program (CMT-C) targeted to caregivers, in promoting significant changes both in caregivers and adolescents in residential youth care. This trial was carried out in accordance with the ethical principles of the Declaration of Helsinki and the applicable national laws and regulations. The ethics committee of the Faculty of Psychology and Educational Sciences of the University of Coimbra approved the study's procedures.
Since CMT-C is targeted for residential care homes' (RCH) teams, for practical reasons (to maximize time and human resources) and to avoid contamination, the unit of randomization was the RCH (i.e., cluster), hence a cluster randomized design was followed according CONSORT guidelines. From the 32 RCH within the Centre region of Portugal, 19 RCH obeying to cluster eligibility criteria were invited to participate. Twelve RCH agreed to enter the trial. Their caregivers and adolescents, who were eligible for the study, were informed of the goals and procedures of this research, and invited to voluntarily participate. No incentives were offered for participation. Written informed consent were sought at the cluster level (from the board of each RCH), and at the individual level to caregivers and adolescents (and their legal guardians), before the randomization occurred. Adolescents aged between 14 and 16 YO, gave informed assent, while the older than 16 YO will give written informed consent. A written informed consent was also gathered from guardians/legal representatives of all adolescent participants under 18 YO. The anonymity of all participants responses was guaranteed, with the use of respondent-specific codes, which were also used to link the data from one time point to the other. Data was collectively collected in each RCH with the presence of an independent researcher, in order to answer any questions and ensure confidentiality. All participants (caregivers and adolescents) were assessed through self-report measures 5 times across 12 months. Specifically, participants were assessed 3 months before the beginning of the CMT-C (Baseline 0 - time 0), before the first session of the program (baseline 1 - time 1), right after its terminus (i.e., post-treatment assessment - time 2), and 3 and 6 months after intervention terminus (follow-up 1 and 2 - time 3 and time 4). Participants in the control group were assessed with the same time intervals as those in intervention group.
After the first baseline assessment, a computer-generated randomization was conducted at the cluster level, following a completely randomized design. Each RCH (i.e., cluster) was randomly assigned to one of two conditions: CMT-C and control group. Six RCH were allocated in the experimental group and received the TMC for caregivers, the remaining 6 constituted the control group. Caregivers in the treatment group attended the CMT-C for about 12 weeks. The CMT-C consisted of twelve, 2.5-hr weekly group sessions, delivered in each RCH to a group of 7 to 10 participants. Caregivers in the control group did not received any mind training or group intervention.
After post-treatment assessments, focus groups were carried out with the caregivers allocated in the CMT-C group, in order to enrich understanding about the participants' experience with the intervention and their perception of change at 3 different levels (individual, interindividual and organizational).
Treatment integrity were ensured through: a) specific treatment manuals; b) direct training of the therapist; c) supervision; and d) assessment of adherence and competence through an integrity rating scale.
Treatment effects will be analyzed following an intention-to-treat analysis using Latent Growth Curve Models (LGCM). The intercept (i.e., initial status) and slope (i.e., change over time) will be modeled as latent variables from longitudinal data (T0 to T4). Per-protocol analysis will also be carried out to investigate treatment effects in completers. Moderator (e.g., clusters) effects will also be tested with Conditional LGCM, and will be included as predictors of change over time in the outcome measures. Nested qualitative evaluation with thematic analysis will be carried out after the last follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMT-C group | Experimental | Behavioral: Compassionate Mind Training for CaregiversCompassion Mind Training for Caregivers (CMT-C) is a 12-session structured program to be delivered in a group format, aiming to cultivate a compassionate-self and compassionate care practices in residential youth care. |
| Control group | No intervention | –This group did not receive any mind training or group intervention during the study. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Compassionate Mind Training for CaregiversCMT-C is a 12-session group program, each lasting about 2,5 hours, which run on a weekly basis. The program is organized across 3 modules: 1) Our mind according to a compassion-based approach (to provide insight into the evolved and socially shaped mind and the affect regulation systems); 2) Compassionate mind training (understanding and cultivating the attributes and competencies of compassion in its three flows, and addressing its fears); and 3) final session (revising key information and practices and its application to the RCH practices/routines). Its sessions have the following structure: 1) Check-in (grounding exercise, reviewing the previous session, sharing the weekly practice); 2) Exploration of the session theme (psychoeducation and experiential practices followed by group opportunities for share experiences and discussion); 3) Check-out (session summary and application to the self, youths and RCH practices, weekly practice challenge, session evaluation, session take-off). | Behavioural | CMT-C group |
Primary outcome
Change of Compassion
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Caregivers reported on the Compassion Scale (CS; Pommier, 2011; Portuguese version by Sousa, Castilho, Vieira, Vagos, \& Rijo, 2017). The CS is a 24-item self-report scale that measures compassion for others. Participants answered each item according to how frequently they feel and act towards others, using a 5-point Likert scale (1 = almost never, to 5 = almost always). In the Portuguese version, a CFA revealed the existence of six subscales and two higher-order factors: Compassion (comprising the positive subscales: Kindness, Common Humanity, Mindfulness) and Disconnectedness (comprising the negative subscales: Indifference, Separation and Disengagement), which represent a positive and a negative valence of compassion.
Change of Self-Compassion
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Caregivers reported on the Self-Compassion Scale (SCS; Neff, 2003; Portuguese version by Castilho, Pinto-Gouveia \& Duarte, 2015). The SCS is a 26 self-reported scale which addresses self-compassion and instructs participants to answer its items, rated in a 5-point Likert scale (1 = almost never, to 5 = almost always), regarding "how I typically act towards myself in difficult times". In the original version, the scale has a total score and six subscales (Self-Kindness; Self-Judgement; Common Humanity; Isolation; Mindfulness; and Over-Identification). The Portuguese version tested a two-factor model, finding that a Self-Compassionate attitude (comprising the positive subscales: Self-Kindness, Common Humanity, Mindfulness) and Self-Critical attitude (comprising the negative subscales: Self-Judgement, Isolation and Over-Identification).
Change of Fears of Compassion
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Caregivers reported on the Fears of Compassion Scales (FCS; Gilbert, McEwan, Matos, \& Rivis, 2011; Portuguese version by Matos, Pinto-Gouveia, Duarte, \& Simões, 2011). The FCS integrates three self-reported scales designed to assess fears of being compassionate toward others (10 items), receiving compassion from others (13 items) and being self-compassionate (15 items). The items were rated on a 5-point Likert scale (0 = Do not agree at all, to 4 = Completely agree).
Change of Social Safeness
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Caregivers reported on the Social Safeness and Pleasure Scale (SSPS; Gilbert et al., 2009; Portuguese version by Dinis, Castilho, Xavier, \& Pinto-Gouveia, 2008). The SSPS is an 11-item unidimensional self-reported scale that assesses the frequency with which individuals experience positive feelings in their social relationships, as well as, they experience the world as a safe and soothing place. Items are rated through a 5-point Likert scale (1 =almost never, to 5=almost always).
Change of Emotional Climate at the workplace
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Caregivers reported on the Emotional Climate in Organizations Scale Adults (ECOS-A; Albuquerque et al., 2018). The ECOS-A is a 30-item self-report scale, aiming to assess how workers felt and behaved at their workplace, over the past two weeks. This scale has two parts (i.e., emotions and motives) with 15 items each. Each one is divided into 3 subscales, with 5 items, referring to the three affect's regulation systems: the threat system, the soothing system and the drive system. All items are answered according to a 5-points Likert's scale (0 =Never, to 4= Always).
11 secondary outcomes
Emotion regulation
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Mental Health Symptoms
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Professional Quality of Life
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Empathy
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Resilience
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Satisfaction with life
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Positive and negative affect
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Warmth and Safeness experiences
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Social safeness
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Emotional Climate in Residential Care Home
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Internalizing and externalizing problems
Time frame: baseline; 3 months; 6 months; 9 months; 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 37360762Santos L, Pinheiro MDR, Rijo D. The Effects of the Compassionate Mind Training for Caregivers on Professional Quality of Life and Mental Health: Outcomes from a Cluster Randomized Trial in Residential Youth Care Settings. Child Youth Care Forum. 2023 May 3:1-21. doi: 10.1007/s10566-023-09749-6. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Rijo, PhD study director
CINEICC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassionate Mind Training for Caregivers in people with Compassion, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Oct 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 Portugal. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Compassion (time frame: baseline; 3 months; 6 months; 9 months; 12 months). The study lists 5 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 NCT04512092, which also lists 1 linked publication.
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 6 Oct 2021.