Parental BurnoutPBA-INTNCT07011641
Parental Burnout Interventions
A study testing Structured Online CBT Program in people with Parental Burnout, run by The Maria Grzegorzewska University, Warsaw at 1 site in Poland.
Trial summary
This interventional, retrospective study evaluated the effectiveness of online therapeutic interventions based on basic principles of cognitive-behavioral therapy (CBT) in reducing parental burnout. A total of 60 participants took part in the study conducted entirely online between June 2021 and September 2022. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parental Burnout
- What is being tested?
- Structured Online CBT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2021to 30 Sep 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years or older)
- Has at least one child currently living at home
- Reports experiencing symptoms of parental burnout
- Willing and motivated to participate in an online therapeutic intervention
- Has access to a device with internet connectivity
Who cannot join
- Current diagnosis of a severe psychiatric disorder (e.g., psychosis, bipolar disorder)
- Currently receiving psychological therapy targeting parental burnout
- Inability to understand and communicate in the language of the intervention
- No access to stable internet or a suitable device
- Participation in another clinical trial during the study period
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Maria Grzegorzewska University in Warsaw
Warsaw, Poland, 02-353
About this study
Official title: Parental Burnout - Checking the Effectiveness of Therapeutic Interventions Based on the Basics of Cognitive-behavioral Therapy
This interventional, retrospective study evaluated the effectiveness of online therapeutic interventions based on basic principles of cognitive-behavioral therapy (CBT) in reducing parental burnout. A total of 60 participants took part in the study conducted entirely online between June 2021 and September 2022. The primary objective was to determine whether a structured intervention, designed specifically for this project, could significantly reduce the levels of burnout experienced by parents. The interventions were delivered remotely and did not involve any pharmacological treatment. The study was conducted after obtaining ethical approval and is being registered retrospectively to ensure transparency and research accessibility.
Read the detailed description
Procedure Following initial screening interviews, parents were randomly assigned to one of four groups of 15 participants each. Two groups immediately received the intervention, while the other two groups served as waiting-list controls, did not participate in the intervention in the described study, but constituted the control group. Mothers in control groups were monitored for burnout levels with the use of the Parental Burnout Assessment (PBA) and were offered the opportunity to receive the intervention six months after their enrolment.
The group-based therapeutic intervention (see below for the detail of the intervention) was delivered to two groups of parents online, while the third and fourth groups were control groups.
After completing an online application form, each parent had a brief online meeting with a psychologist to assess the eligibility criteria, i.e.: having at least one child still living at home, experiencing symptoms of parental burnout, and being motivated to participate in therapeutic interactions. During the meeting, parents were asked to explain their reasons for wishing to join the group. On that basis, parents whose expectations did not relate to the reduction of parental burnout symptoms (e.g., improvement of a disabled child functioning) were excluded. Due to the fact that parental burnout increases the risk of suicide, all persons who volunteered for the project were diagnosed in this respect during the first individual meeting with a psychologist, and were invited to the first intervention group, if the risk of suicidal thoughts or tendencies appeared.
After the online consultation, the method for delivering the parental burnout questionnaire and the informed consent form was established. These documents were provided in paper form and subsequently returned by the participants to the study author. The content of the informed consent form was approved by the Ethics Committee, and the entire procedure was conducted in accordance with the 1964 Declaration of Helsinki. The study was conducted in accordance with the recommendations of the Research Ethics Committee of the Maria Grzegorzewska University in Warsaw (Consent No. 27/2021).
All signed an informed consent form and were advised of their right to withdraw from the study at any time. To ensure data confidentiality, participants were identified by means of anonymous codes. The eligible parents were randomly assigned to four groups (1- intervention, 2- intervention, 3-control and 4-control). Only those who exhibited suicidal thoughts / tendencies or scored more than 53 points on the PBA questionnaire, which suggest high degree of parental burnout were given priority to the intervention group. However, in this study none of the parents revealed any suicide risk. In order to comply with all ethical standards, those in the control groups were given an opportunity to participate in a free of charge intervention after the final stage of the study, like the other groups. Parents were assessed three times: T1 baseline, T2 post-intervention or equivalent timing for controls and T3 six-month follow-up.
- Conditions
- Parental Burnout
- Being tested
- Structured Online CBT Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Online CBT ProgramBehavioural
The interventions consisted of eight weekly group sessions (1.5-2 hours each), with each session addressing a specific theme identified through literature as closely related to parental burnout. The sequential themes were the social pressure on parenting, the dynamic balance of parental stressors and resources, parental perfectionism, personal emotional competencies, parent-child relationship quality, co-parenting quality, help seeking, with a last session focused on relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Intervention group | Experimental | Not described Receives: Behavioral: Structured Online CBT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parental Burnout as measured by the Parental Burnout Assessment (PBA)
Change in total scores on the Parental Burnout Assessment (PBA) from baseline to the end of the 8-week online intervention. Higher scores reflect greater parental burnout. The scale includes emotional exhaustion, contrast with previous parental self, emotional distancing, and feelings of being fed up.
Measured: From baseline to month 6 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start1 Jun 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental BurnoutStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Maria Grzegorzewska University, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawid Scigala, The Maria Grzegorzewska University, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011641
- Sponsor's protocol ID
- PBA2021
- Other IDs
- CONSENT NO. 27/2021
- Acronym
- PBA-INT
- Status last verified
- May 2025
- First submitted
- 31 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Burnout - Checking the Effectiveness of Therapeutic Interventions Based on the Basics of Cognitive-behavioral Therapy
- ClinicalTrials.gov ID
- NCT07011641
- Acronym / sponsor ID
- PBA-INT / PBA2021
- Conditions
- Parental Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Maria Grzegorzewska University, WarsawUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Jun 2025 (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 interventional, retrospective study evaluated the effectiveness of online therapeutic interventions based on basic principles of cognitive-behavioral therapy (CBT) in reducing parental burnout. A total of 60 participants took part in the study conducted entirely online between June 2021 and September 2022. The primary objective was to determine whether a structured intervention, designed specifically for this project, could significantly reduce the levels of burnout experienced by parents. The interventions were delivered remotely and did not involve any pharmacological treatment. The study was conducted after obtaining ethical approval and is being registered retrospectively to ensure transparency and research accessibility.
Detailed description
Procedure Following initial screening interviews, parents were randomly assigned to one of four groups of 15 participants each. Two groups immediately received the intervention, while the other two groups served as waiting-list controls, did not participate in the intervention in the described study, but constituted the control group. Mothers in control groups were monitored for burnout levels with the use of the Parental Burnout Assessment (PBA) and were offered the opportunity to receive the intervention six months after their enrolment.
The group-based therapeutic intervention (see below for the detail of the intervention) was delivered to two groups of parents online, while the third and fourth groups were control groups.
After completing an online application form, each parent had a brief online meeting with a psychologist to assess the eligibility criteria, i.e.: having at least one child still living at home, experiencing symptoms of parental burnout, and being motivated to participate in therapeutic interactions. During the meeting, parents were asked to explain their reasons for wishing to join the group. On that basis, parents whose expectations did not relate to the reduction of parental burnout symptoms (e.g., improvement of a disabled child functioning) were excluded. Due to the fact that parental burnout increases the risk of suicide, all persons who volunteered for the project were diagnosed in this respect during the first individual meeting with a psychologist, and were invited to the first intervention group, if the risk of suicidal thoughts or tendencies appeared.
After the online consultation, the method for delivering the parental burnout questionnaire and the informed consent form was established. These documents were provided in paper form and subsequently returned by the participants to the study author. The content of the informed consent form was approved by the Ethics Committee, and the entire procedure was conducted in accordance with the 1964 Declaration of Helsinki. The study was conducted in accordance with the recommendations of the Research Ethics Committee of the Maria Grzegorzewska University in Warsaw (Consent No. 27/2021).
All signed an informed consent form and were advised of their right to withdraw from the study at any time. To ensure data confidentiality, participants were identified by means of anonymous codes. The eligible parents were randomly assigned to four groups (1- intervention, 2- intervention, 3-control and 4-control). Only those who exhibited suicidal thoughts / tendencies or scored more than 53 points on the PBA questionnaire, which suggest high degree of parental burnout were given priority to the intervention group. However, in this study none of the parents revealed any suicide risk. In order to comply with all ethical standards, those in the control groups were given an opportunity to participate in a free of charge intervention after the final stage of the study, like the other groups. Parents were assessed three times: T1 baseline, T2 post-intervention or equivalent timing for controls and T3 six-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Intervention group | Experimental | Behavioral: Structured Online CBT Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18 years or older)
- Has at least one child currently living at home
- Reports experiencing symptoms of parental burnout
- Willing and motivated to participate in an online therapeutic intervention
- Has access to a device with internet connectivity
Key exclusion criteria (5 listed)
- Current diagnosis of a severe psychiatric disorder (e.g., psychosis, bipolar disorder)
- Currently receiving psychological therapy targeting parental burnout
- Inability to understand and communicate in the language of the intervention
- No access to stable internet or a suitable device
- Participation in another clinical trial during the study period
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 |
|---|---|---|
| Structured Online CBT ProgramThe interventions consisted of eight weekly group sessions (1.5-2 hours each), with each session addressing a specific theme identified through literature as closely related to parental burnout. The sequential themes were the social pressure on parenting, the dynamic balance of parental stressors and resources, parental perfectionism, personal emotional competencies, parent-child relationship quality, co-parenting quality, help seeking, with a last session focused on relapse prevention. | Behavioural | Intervention group |
Primary outcome
Change in Parental Burnout as measured by the Parental Burnout Assessment (PBA)
Time frame: From baseline to month 6 (end of intervention)
Change in total scores on the Parental Burnout Assessment (PBA) from baseline to the end of the 8-week online intervention. Higher scores reflect greater parental burnout. The scale includes emotional exhaustion, contrast with previous parental self, emotional distancing, and feelings of being fed up.
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 15 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Online CBT Program in people with Parental Burnout, run by The Maria Grzegorzewska University, Warsaw at 1 site in Poland.
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 5 inclusion and 5 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 15 Jun 2025. 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 Poland. 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?
Change in Parental Burnout as measured by the Parental Burnout Assessment (PBA) (time frame: From baseline to month 6 (end of intervention)). 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 15 Jun 2025.