Burnout SyndromeUupuNCT04250012
Web-based ACT to Support Parents With Children With Chronic and Developmental Conditions
A study testing Internet-based ACT intervention and Psychoeducation in people with Burnout Syndrome and Psychological Distress, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
Parents of children with a chronic disease or functional disabilities have an increased risk of stress-related distress and reduced quality of life. Internet-delivered interventions are one way to reach out to exhausted parents who may often have challenges in finding time to access face-to-face services. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome, Psychological Distress, Depressive Symptoms
- What is being tested?
- Internet-based ACT intervention and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFinland
- Study dates
- 28 Jan 2019to 15 Dec 2020
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The parent:
- has a child (aged 0-18 years) with a long-term illness or developmental disorder or disability,
- has symptoms of burnout based on the Shirom-Melamed Burnout questionnaire (SMBQ), i.e. at least 2.75 points.
- has access to computer and internet.
Who cannot join
- The parent:
- has an inadequate knowledge of the Finnish language (unable to fill in questionnaires or follow the program);
- has parallel regular psychological treatment or therapy
- has a severe mental disorder.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Psychology, University of Jyväskylä
Jyväskylä, 40014
About this study
Official title: Effectiveness of a Web-based Acceptance and Commitment Therapy for Wellbeing of Parents With Children With Chronic and Developmental Conditions: A Randomized Controlled Trial
Parents of children with a chronic disease or functional disabilities have an increased risk of stress-related distress and reduced quality of life. Internet-delivered interventions are one way to reach out to exhausted parents who may often have challenges in finding time to access face-to-face services. We developed a guided web-based Acceptance and Commitment Therapy intervention for Finnish parents of children with chronic conditions or functional disabilities. Participants (N=100) will be recruited on parent associations' Facebook groups and randomly assigned to guided web-based ACT condition and a control condition receiving psychoeducation. The guided web-based ACT condition will receive a 10-week web intervention including three remote meetings with a psychologist through the telemedicine application Doxy.me. Symptoms of burnout (SMBQ), depression (PHQ), health-related quality of life (RAND-36), mindfulness (FFMQ), general measure of psychological flexibility (CompACT) as well as the wellbeing of their child (KINDL) will be measured before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. In this randomized controlled trial we will investigate the outcomes and the mechanisms of change of the web-based ACTintervention. In addition, we will examine the acceptability of the web-based intervention.
Read the detailed description
Numerous studies have shown that parents of children with long-term and intellectual disabilities suffer more often from symptoms such as stress, anxiety and depression symptoms, feelings of uncertainty and fear, and loss of quality of life. In Finland, there are approximately 17.000 families where the illness or disability of a child under the age of 16 causes an extra daily burden for parents. Especially mothers of long-term or disabled children are vulnerable and have an increased risk of psychological symptoms. Parents of children with a chronic disease or functional disability also have an increased risk of stress-related distress and reduced quality of life. Prolonged psychological symptoms associated with caring for a child with a long-term illness can expose to chronic exhaustion and burnout, which can have serious health effects. The birth of a disabled child and the illness of a child with long-term illness also increases the risk of divorce in the family. Considering the hardship and challenges of this population group, special attention should be paid to their rehabilitation and access to services.
In Finland, for example, the Finnish Social Insurance Institution offers adaptation training and family-oriented rehabilitation courses for family caregivers. However, this form of support has limited availability and, on the other hand, is of relatively short duration. Several studies indicate, however, that the parents' mental health also affects the health and development of the child, and especially the long-term stress experienced by the parent can be harmful to children. The challenge is to motivate parents to take care of themselves and thus to have a better capacity to care for their children in need of special support. The majority of parents have a full-time employment, which also poses challenges for the forms of support. Therefore, the support of this parent group should focus on treatments that are easily available for them.
Web-based treatments offer one solution for delivering evidence-based psychological treatments for this distressed parents, who may often have challenges in finding time to access face-to-face services. Web-based interventions have been developed and tested for a wide range of health problems, including parental wellbeing. Advantages of web-based interventions are that they are not bound to time and place. They are available when most needed and enable integration of the intervention in everyday life.
Acceptance and commitment therapy (ACT) represents the third-wave of Cognitive Behavioral Therapies and incorporates mindfulness, experiential acceptance, and valued action (e.g., engagement in meaningful, values-driven activities) to promote psychological flexibility. Several studies and meta-analyses have shown that acceptance and commitment therapy has a positive effect on a variety of psychological symptoms. Promising results from web-based ACT interventions have been obtained for example for the treatment of stress, anxiety, and depression. ACT and other mindfulness-based treatments have been shown to improve psychological adjustment and to decrease stress in parents of children with developmental disabilities including autism and acquired brain injury.
The aim of the current study is to investigate the effectiveness of a web-based ACT intervention on wellbeing of parents with exhaustion and burnout symptoms, and whose children have chronic conditions and/or developmental disabilities. Effects will be investigated at before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. The research questions are the following:
- Does the guided acceptance and commitment-based online intervention decrease the burnout and depression symptoms of parents of children with long-term illnesses and improve their quality of life, psychological flexibility, mindfulness skills, and cognitive strategies?
- Which psychological processes (i.e., psychological flexibility, mindfulness skills, cognitive strategies) act as mediators of change?
- Do the changes in the well-being of the parents improve the quality of life of the child?
- How do parents experience online intervention and what kind of parent group especially will benefit from online support?
- Being tested
- Internet-based ACT intervention, Psychoeducation
- Keywords
- Parents, burnout, parental distress, Internet-based, ACT
- Medical subject headings
- Burnout, Psychological, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based ACT interventionBehavioural
The Internet-based ACT intervention included a 10-week web-based program consisting of five modules with different themes that the participants were instructed to process during the course of two weeks. The program was based on the processes of ACT and included themes such as life values, mindfulness, defusion, self-as-context acceptance and self-compassion. The content of each module consisted of text, video, exercises with audio files, and homework assignments. In addition, the participants filled in a diary with exercises in paper format. The intervention included also three remote meetings (à 45 minutes) via a videoconferencing tool doxy.me conducted by a psychologist. The remote meetings took place at the beginning, after 4 weeks, and at the end of the intervention.
PsychoeducationBehavioural
The psychoeducation group received a self-help booklet and a link to a web-based wellness training program. The program included exercises with MP3 audio files. No personal support during the 10-week intervention was provided.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based ACT intervention | Experimental | Group "Internet-based ACT intervention" will receive a 10-week internet-based acceptance and commitment therapy intervention with three remote meetings with a psychologist Receives: Behavioral: Internet-based ACT intervention |
| Psychoeducation | Active comparator | Group "Psychoeducation" will receive a self-help booklet and a link to mobile wellness training program Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burnout
Burnout symptoms were measured with the Shirom-Melamed Burnout Questionnaire (SMBQ, Lundgren-Nilsson, Jonsdottir, Pallant, \& Ahlborg, 2012; Melamed et al., 1999; Shirom \& Melamed, 2006). The SMBQ measures four elements of burnout; Emotional exhaustion and physical fatigue, Listlessness, Tension, and Cognitive weariness. The SMBQ consists of 22 items that are rated on a seven-point scale ranging from 1 'Never or almost never' to 7 'Always or almost always'. High scores correspond to more burnout symptoms. The cut-off scores for burnout on the SMBQ are 2.75 - 3.74 indicating low burnout, 3,75 - 4,46 indicating high burnout and ≥ 4.47 indicating pathological level of burnout. SMBQ's psychometric characteristics and factorial validity have been supported (Lundgren-Nilsson et al., 2012; Shirom \& Melamed, 2006).
Measured: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Secondary outcomes (5)
Depression (PHQ-9)
The PHQ-9 is one module of the larger Patient Health Questionnaire (Spitzer, Williams, \& Kroenke, 2001), a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 comprises nine items that evaluate the presence of the nine Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (APA, 2000a) criteria for major depressive disorder in the previous 2 weeks. Each item of the PHQ-9 is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), for a total score ranging from 0 to 27. A final item assesses the perception of social, functional, and occupational impairment caused by the symptoms examined by the PHQ-9. Higher scores indicate an increased severity of depression symptoms .
Measured: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Health-related quality of life (RAND-36) Health-related quality of life (RAND-36) Health-related quality of life (RAND-36)
The health-related quality of life (HRQL) will be measured with the Short-form 36 (SF-36), which is a validated and widely used generic quality of life questionnaire with good reliability. It consists of 36 questions measuring eight dimensions of quality of life: physical functioning, role functioning, pain, general health, vitality, social functioning, role functioning and mental health. Physical and mental component summary scores will be calculated. All 36 questions are scored on a scale from 0 to 100. Each scale is directly transformed into a 0-100 scale, with 100 representing the highest level of functioning possible. Lower scores indicate a worse outcome, i.e. more disability.
Measured: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Mindfulness (FFMQ)
Mindfulness was assessed by the Five Facet Mindfulness Questionnaire (FFMQ, Baer et al., 2006). It includes 39-items that are rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of mindfulness skills. It includes the following elements. (a) Observing (b) Describing (c) Acting with awareness means (d) Non-judgment of inner experiences toward inner experiences. (e) Non-reactivity to inner experiences. The structure, reliability and validity of FFMQ have been supported (Baer et al., 2008).Higher scores indicate a better outcome, i.e. better mindfulness skills.
Mindfulness was assessed by the Five Facet Mindfulness Questionnaire (FFMQ, Baer et al., 2006). It includes 39-items
Measured: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Psychological flexibility and ACT-related processes (CompACT)
The Comprehensive Assessments of Acceptance and Commitment Therapy processes (CompACT; Francis et al., 2016) is a self-report questionnaire, with 23-items on a 7-points likert scale (0 = Strongly disagree, 6 = Strongly agree). The three-factor structure of the CompACT is concordant with recent accounts of psychological flexibility in terms of three dyadic processes; defined as: (1) openness to experience (acceptance; defusion); (2) behavioral awareness (present moment awareness; self as context); and (3) valued action (values; committed action). Higher scores in the full-scale (max 138 points) and on the subscales (Openness to experience, max 60 points, behavioral awareness, max 30 points, and valued action, max 48 points) indicate greater psychological flexibility, ie. a better outcome. These factors have demonstrated strong internal consistency.
Measured: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Health-related quality of life in children (KINDL)
The KINDL questionnaire is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17. There are three different versions of the instrument suitable for different age groups and developmental stages. Each version of the questionnaire can be completed both by children and adolescents, and also by their parents. The KINDL-questionnaire comprises twenty-four items yielding six dimensions (physical health, general health, family functioning, self-esteem, social functioning and school functioning) and a total score. The total score is transformed to a scale of 0-100 such that higher score represents a better outcome, i.e. better HRQoL.
Measured: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start28 Jan 2019
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout SyndromeStudies 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
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerocenter Foundation for Research and Development, Social Insurance Institution, Finland
- Responsible party
- Principal investigator, Päivi Lappalainen, University of Jyvaskyla
- Investigators
- Raimo Lappalainen, PhD, Study director, Department of Psychology, University of Jyväskylä
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250012
- Sponsor's protocol ID
- 18/26/2018
- Acronym
- Uupu
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Web-based Acceptance and Commitment Therapy for Wellbeing of Parents With Children With Chronic and Developmental Conditions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04250012
- Acronym / sponsor ID
- Uupu / 18/26/2018
- Keywords
- Parents, burnout, parental distress, Internet-based, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- The Gerocenter Foundation for Research and Development, Social Insurance Institution, Finland
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 31 Jan 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.
Parents of children with a chronic disease or functional disabilities have an increased risk of stress-related distress and reduced quality of life. Internet-delivered interventions are one way to reach out to exhausted parents who may often have challenges in finding time to access face-to-face services. We developed a guided web-based Acceptance and Commitment Therapy intervention for Finnish parents of children with chronic conditions or functional disabilities. Participants (N=100) will be recruited on parent associations' Facebook groups and randomly assigned to guided web-based ACT condition and a control condition receiving psychoeducation. The guided web-based ACT condition will receive a 10-week web intervention including three remote meetings with a psychologist through the telemedicine application Doxy.me. Symptoms of burnout (SMBQ), depression (PHQ), health-related quality of life (RAND-36), mindfulness (FFMQ), general measure of psychological flexibility (CompACT) as well as the wellbeing of their child (KINDL) will be measured before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. In this randomized controlled trial we will investigate the outcomes and the mechanisms of change of the web-based ACTintervention. In addition, we will examine the acceptability of the web-based intervention.
Detailed description
Numerous studies have shown that parents of children with long-term and intellectual disabilities suffer more often from symptoms such as stress, anxiety and depression symptoms, feelings of uncertainty and fear, and loss of quality of life. In Finland, there are approximately 17.000 families where the illness or disability of a child under the age of 16 causes an extra daily burden for parents. Especially mothers of long-term or disabled children are vulnerable and have an increased risk of psychological symptoms. Parents of children with a chronic disease or functional disability also have an increased risk of stress-related distress and reduced quality of life. Prolonged psychological symptoms associated with caring for a child with a long-term illness can expose to chronic exhaustion and burnout, which can have serious health effects. The birth of a disabled child and the illness of a child with long-term illness also increases the risk of divorce in the family. Considering the hardship and challenges of this population group, special attention should be paid to their rehabilitation and access to services.
In Finland, for example, the Finnish Social Insurance Institution offers adaptation training and family-oriented rehabilitation courses for family caregivers. However, this form of support has limited availability and, on the other hand, is of relatively short duration. Several studies indicate, however, that the parents' mental health also affects the health and development of the child, and especially the long-term stress experienced by the parent can be harmful to children. The challenge is to motivate parents to take care of themselves and thus to have a better capacity to care for their children in need of special support. The majority of parents have a full-time employment, which also poses challenges for the forms of support. Therefore, the support of this parent group should focus on treatments that are easily available for them.
Web-based treatments offer one solution for delivering evidence-based psychological treatments for this distressed parents, who may often have challenges in finding time to access face-to-face services. Web-based interventions have been developed and tested for a wide range of health problems, including parental wellbeing. Advantages of web-based interventions are that they are not bound to time and place. They are available when most needed and enable integration of the intervention in everyday life.
Acceptance and commitment therapy (ACT) represents the third-wave of Cognitive Behavioral Therapies and incorporates mindfulness, experiential acceptance, and valued action (e.g., engagement in meaningful, values-driven activities) to promote psychological flexibility. Several studies and meta-analyses have shown that acceptance and commitment therapy has a positive effect on a variety of psychological symptoms. Promising results from web-based ACT interventions have been obtained for example for the treatment of stress, anxiety, and depression. ACT and other mindfulness-based treatments have been shown to improve psychological adjustment and to decrease stress in parents of children with developmental disabilities including autism and acquired brain injury.
The aim of the current study is to investigate the effectiveness of a web-based ACT intervention on wellbeing of parents with exhaustion and burnout symptoms, and whose children have chronic conditions and/or developmental disabilities. Effects will be investigated at before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. The research questions are the following:
- Does the guided acceptance and commitment-based online intervention decrease the burnout and depression symptoms of parents of children with long-term illnesses and improve their quality of life, psychological flexibility, mindfulness skills, and cognitive strategies?
- Which psychological processes (i.e., psychological flexibility, mindfulness skills, cognitive strategies) act as mediators of change?
- Do the changes in the well-being of the parents improve the quality of life of the child?
- How do parents experience online intervention and what kind of parent group especially will benefit from online support?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based ACT intervention | Experimental | Behavioral: Internet-based ACT interventionGroup "Internet-based ACT intervention" will receive a 10-week internet-based acceptance and commitment therapy intervention with three remote meetings with a psychologist |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationGroup "Psychoeducation" will receive a self-help booklet and a link to mobile wellness training program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- has a child (aged 0-18 years) with a long-term illness or developmental disorder or disability,
- has symptoms of burnout based on the Shirom-Melamed Burnout questionnaire (SMBQ), i.e. at least 2.75 points.
- has access to computer and internet.
Key exclusion criteria (4 listed)
- has an inadequate knowledge of the Finnish language (unable to fill in questionnaires or follow the program);
- has parallel regular psychological treatment or therapy
- has a severe mental disorder.
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-based ACT interventionThe Internet-based ACT intervention included a 10-week web-based program consisting of five modules with different themes that the participants were instructed to process during the course of two weeks. The program was based on the processes of ACT and included themes such as life values, mindfulness, defusion, self-as-context acceptance and self-compassion. The content of each module consisted of text, video, exercises with audio files, and homework assignments. In addition, the participants filled in a diary with exercises in paper format. The intervention included also three remote meetings (à 45 minutes) via a videoconferencing tool doxy.me conducted by a psychologist. The remote meetings took place at the beginning, after 4 weeks, and at the end of the intervention. | Behavioural | Internet-based ACT intervention |
| PsychoeducationThe psychoeducation group received a self-help booklet and a link to a web-based wellness training program. The program included exercises with MP3 audio files. No personal support during the 10-week intervention was provided. | Behavioural | Psychoeducation |
Primary outcome
Burnout
Time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Burnout symptoms were measured with the Shirom-Melamed Burnout Questionnaire (SMBQ, Lundgren-Nilsson, Jonsdottir, Pallant, \& Ahlborg, 2012; Melamed et al., 1999; Shirom \& Melamed, 2006). The SMBQ measures four elements of burnout; Emotional exhaustion and physical fatigue, Listlessness, Tension, and Cognitive weariness. The SMBQ consists of 22 items that are rated on a seven-point scale ranging from 1 'Never or almost never' to 7 'Always or almost always'. High scores correspond to more burnout symptoms. The cut-off scores for burnout on the SMBQ are 2.75 - 3.74 indicating low burnout, 3,75 - 4,46 indicating high burnout and ≥ 4.47 indicating pathological level of burnout. SMBQ's psychometric characteristics and factorial validity have been supported (Lundgren-Nilsson et al., 2012; Shirom \& Melamed, 2006).
5 secondary outcomes
Depression (PHQ-9)
Time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Health-related quality of life (RAND-36) Health-related quality of life (RAND-36) Health-related quality of life (RAND-36)
Time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Mindfulness (FFMQ)
Time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Psychological flexibility and ACT-related processes (CompACT)
Time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Health-related quality of life in children (KINDL)
Time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
Raimo Lappalainen, PhD study director
Department of Psychology, University of Jyväskylä
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-based ACT intervention and Psychoeducation in people with Burnout Syndrome and Psychological Distress, run by University of Jyvaskyla at 1 site in Finland.
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 4 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: finished, as of the sponsor's last update on 24 Feb 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Burnout (time frame: Change from baseline at 3 months, 7 months and 10 months after the pre-measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.