Caregiver BurdenNCT05613595
Effectiveness of Positive Psychotherapy on Mental Wellbeing Among Caregivers of Cerebral Palsy Children
A study testing Positive Psychotherapy and Counseling Group in people with Caregiver Burden and Mental Health Issue, run by International Islamic University, Islamabad at 1 site in Pakistan.
Trial summary
The Central idea of the proposed research proposal is first to translate adapt and validate the Caregiver Difficulties Scale \& Positive Psychotherapy sessions based manual into Urdu language then secondly, assessment of burnout, burden, depression, mental wellbeing, sense of coherence and social support among… Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Caregiver Burden, Mental Health Issue, Cerebral Palsy
- What is being tested?
- Positive Psychotherapy and Counseling Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Nov 2021to 31 Aug 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Only those participants will be included who would have moderate to high score on caregiver burden, depression \& burnout and lower score in wellbeing, social support \& sense of coherence.
- Interventions will be given to the caregivers having moderate level of burnout \& depression.
- Caregiver will be someone who takes the primary responsibility for caregiving a child with CP.
- Only caregivers of Diagnosed CP child
- Caregivers having only 1 CP child in the family
- Educational status of the care giver will be matric and above.
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- Age of CP child under 10 years Exclusion Criteria:• Caregivers with any severe diagnosed Psychiatric illness (psychosis \& depressive Illness) will not be added in the present study.
- More than 1 CP child in the family
- Caregivers who are Uneducated will not be added in the present study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Rehabilitation Medicine
Islamabad
Farwah Ali
About this study
Official title: Effectiveness of Positive Psychotherapy on Mental Wellbeing, Sense of Coherence, Social Support and Difficulties Among Caregivers of Cerebral Palsy Children
The Central idea of the proposed research proposal is first to translate adapt and validate the Caregiver Difficulties Scale \& Positive Psychotherapy sessions based manual into Urdu language then secondly, assessment of burnout, burden, depression, mental wellbeing, sense of coherence and social support among caregivers of Cerebral palsy children and finally measuring the effectiveness of Positive Psychotherapy for treating mental health issues of caregivers of Cerebral Palsy children. This research proposal will provide an Urdu language based standardized positive psycho therapeutic based intervention to mental health practitioners for treating mental health issues of caregivers of cerebral palsy children in sociocultural context of Pakistan. In Pakistan earlier conducted researches mainly focused on assessment of mental health issues of caregivers of cerebral palsy children, however present research will not only assess the sample regarding their mental health issues, but in addition it will also contribute in provision of psychometrically sound Urdu language based positive Psychotherapy. Positive Psychotherapy focuses on positive emotions and personal strengths instead of ruminating over weaknesses.
Read the detailed description
Cerebral palsy (CP) is a congenital neurodevelopmental disorder, due to non-progressive disability it prolongs throughout ages. Mental health of the caregivers of CP children is affected due to prolong treatment of the child. Keeping in mind the long term multiple disability in cerebral palsy much focus in earlier researches were given to the rehabilitation of the child and less attention is given to address the mental health issues of caregivers of cerebral palsy children. The current study is based on identifying the mental health issues like depression, caregiver burden and burnout among caregivers of CP children and how sense of coherence and social support have impact on the mental wellbeing of caregivers of CP children. After measuring the level of mental health issues of care givers of cerebral palsy children, the present study also aimed at rehabilitation of the caregivers of cerebral palsy children with the help of positive psychotherapy in rehabilitation unit. The positive psychotherapy based interventions will be translated and adapted in Urdu language for the present study. According to the literature review no such positive psychotherapy based techniques used on caregivers of CP Children in Pakistan. Positive Psychotherapy is selected as an interventional therapy in the present study and for the first time it has been planned for this sample in Pakistan. Core focus of positive psychotherapy is to move away the client from negative aspect of life and focus them towards the positive aspects of life. If positive psychotherapy treatment is effective as compared to traditional treatment approach it will be cost effective and will reduce caregiver burden, depression and burnout.
- Conditions
- Caregiver Burden, Mental Health Issue, Cerebral Palsy
- Being tested
- Positive Psychotherapy, Counseling Group
- Keywords
- Positive psychotherapy, Sense of Coherence, Social support
- Medical subject headings
- Caregiver Burden, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychotherapyBehavioural
Positive Psychotherapy is an effective treatment for many mental disorders and depression is primary empirical target. Its primary goal is to build positive emotion, engagement, and meaning in life that will alleviate depression and other mental health disorders. Thus PPT may offer a new way to treat and prevent mental health issues.
Interventions sessions included, Session Records Session One: Positive Introduction and Gratitude Journal Session Two: Character Strengths and Signature Strengths Session Three: Practical Wisdom , Session Four: A Better Version of Me , Session Five: Open and Closed Memories, Session Six: Forgiveness Session Seven: Maximizing versus Satisficing, Session Eight: Gratitude ,Session Nine: Hope and Optimism, Session Ten: Posttraumatic Growth, Session Eleven: Slowness and Savoring, Session Twelve: Positive Relationships, Session Thirteen: Positive Communication, Session Fourteen: Altruism , Session Fifteen: Meaning and Purpose
Counseling GroupBehavioural
Caregivers in control group only regular counseling will be provided (psychoeducation). it will be based upon the insight of cerebral palsy and training based on Adaptive skill functioning of the CP child of the caregivers
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychotherapy Group | Active comparator | In this phase of the study, the caregivers of CP having moderate to high scores on mental health issues on three scales (Depression, Burnout \& Caregiver burden) will receive positive Psychotherapy sessions for a period of four months, divided over different weekly sessions. For Psychotherapy treatment group participants will be given both counseling as well as Positive psychotherapy based interventions. . Each session will be based upon individual session and duration of the session will be 40 minutes. Before starting every session feedback will be taken about the previous session and home based assignments will also be discussed Receives: Behavioral: Positive Psychotherapy |
| Counseling Group | Active comparator | 10 participants will be included in in control group (N=10), for control group caregivers will be given regular counseling as a part of treatment of their child (psychoeducation). Each session will be based upon individual session and duration of the session will be 40 minutes. Receives: Behavioral: Counseling Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parental Burnout Assessment
a 23- item self-report questionnaire for assessment of Burn Out
Measured: baseline and 8th week
Change in Depression Anxiety Stress Scale
DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress
Measured: baseline and 8th week
Change in Caregiver Difficulties Scale
a self-administered questionnaire measure the caregiver burden
Measured: baseline and 8th week
Change in Sense of Coherence
Measured by the orientation of life scale, It contains 13 items
Measured: baseline and 8th week
Change in wellbeing Positive Psychotherapy Inventory
self-report inventory having 25 items.it assess level of mental wellbeing,
Measured: baseline and 8th week
Change Multidimensional Scale of Perceived Social Support
Social support is measured across three domains; friends, family and significant others. The responses reflect participant's perception of support from each of these three sources
Measured: baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start11 Nov 2021
- Primary completion12 Jan 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Model description
- Present study will be conducted on caregivers of Cerebral palsy children. It will be conducted in four phases. In phase I, Urdu translation \& adaptation of Caregiver Difficulties Scale (CDS) and Positive Psychotherapy (PPT) manual will be done. .
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Islamic University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima Waqar, International Islamic University, Islamabad
- Investigators
- Rabia Mushtaq, PhD, Study director, International Islamic University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613595
- Sponsor's protocol ID
- 60-FSS/PHDPSY/F18
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Positive Psychotherapy on Mental Wellbeing, Sense of Coherence, Social Support and Difficulties Among Caregivers of Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT05613595
- Acronym / sponsor ID
- 60-FSS/PHDPSY/F18
- Conditions
- Caregiver Burden, Mental Health Issue, Cerebral Palsy
- Keywords
- Positive psychotherapy, Sense of Coherence, Social support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- International Islamic University, IslamabadUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 12 Jan 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 14 Nov 2022 (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.
The Central idea of the proposed research proposal is first to translate adapt and validate the Caregiver Difficulties Scale \& Positive Psychotherapy sessions based manual into Urdu language then secondly, assessment of burnout, burden, depression, mental wellbeing, sense of coherence and social support among caregivers of Cerebral palsy children and finally measuring the effectiveness of Positive Psychotherapy for treating mental health issues of caregivers of Cerebral Palsy children. This research proposal will provide an Urdu language based standardized positive psycho therapeutic based intervention to mental health practitioners for treating mental health issues of caregivers of cerebral palsy children in sociocultural context of Pakistan. In Pakistan earlier conducted researches mainly focused on assessment of mental health issues of caregivers of cerebral palsy children, however present research will not only assess the sample regarding their mental health issues, but in addition it will also contribute in provision of psychometrically sound Urdu language based positive Psychotherapy. Positive Psychotherapy focuses on positive emotions and personal strengths instead of ruminating over weaknesses.
Detailed description
Cerebral palsy (CP) is a congenital neurodevelopmental disorder, due to non-progressive disability it prolongs throughout ages. Mental health of the caregivers of CP children is affected due to prolong treatment of the child. Keeping in mind the long term multiple disability in cerebral palsy much focus in earlier researches were given to the rehabilitation of the child and less attention is given to address the mental health issues of caregivers of cerebral palsy children. The current study is based on identifying the mental health issues like depression, caregiver burden and burnout among caregivers of CP children and how sense of coherence and social support have impact on the mental wellbeing of caregivers of CP children. After measuring the level of mental health issues of care givers of cerebral palsy children, the present study also aimed at rehabilitation of the caregivers of cerebral palsy children with the help of positive psychotherapy in rehabilitation unit. The positive psychotherapy based interventions will be translated and adapted in Urdu language for the present study. According to the literature review no such positive psychotherapy based techniques used on caregivers of CP Children in Pakistan. Positive Psychotherapy is selected as an interventional therapy in the present study and for the first time it has been planned for this sample in Pakistan. Core focus of positive psychotherapy is to move away the client from negative aspect of life and focus them towards the positive aspects of life. If positive psychotherapy treatment is effective as compared to traditional treatment approach it will be cost effective and will reduce caregiver burden, depression and burnout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Present study will be conducted on caregivers of Cerebral palsy children. It will be conducted in four phases. In phase I, Urdu translation \& adaptation of Caregiver Difficulties Scale (CDS) and Positive Psychotherapy (PPT) manual will be done. .
| Arm | Type | Receives |
|---|---|---|
| Positive Psychotherapy Group | Active comparator | Behavioral: Positive PsychotherapyIn this phase of the study, the caregivers of CP having moderate to high scores on mental health issues on three scales (Depression, Burnout \& Caregiver burden) will receive positive Psychotherapy sessions for a period of four months, divided over different weekly sessions. For Psychotherapy treatment group participants will be given both counseling as well as Positive psychotherapy based interventions. . Each session will be based upon individual session and duration of the session will be 40 minutes. Before starting every session feedback will be taken about the previous session and home based assignments will also be discussed |
| Counseling Group | Active comparator | Behavioral: Counseling Group10 participants will be included in in control group (N=10), for control group caregivers will be given regular counseling as a part of treatment of their child (psychoeducation). Each session will be based upon individual session and duration of the session will be 40 minutes. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Only those participants will be included who would have moderate to high score on caregiver burden, depression \& burnout and lower score in wellbeing, social support \& sense of coherence.
- Interventions will be given to the caregivers having moderate level of burnout \& depression.
- Caregiver will be someone who takes the primary responsibility for caregiving a child with CP.
- Only caregivers of Diagnosed CP child
- Caregivers having only 1 CP child in the family
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Positive PsychotherapyPositive Psychotherapy is an effective treatment for many mental disorders and depression is primary empirical target. Its primary goal is to build positive emotion, engagement, and meaning in life that will alleviate depression and other mental health disorders. Thus PPT may offer a new way to treat and prevent mental health issues. Interventions sessions included, Session Records Session One: Positive Introduction and Gratitude Journal Session Two: Character Strengths and Signature Strengths Session Three: Practical Wisdom , Session Four: A Better Version of Me , Session Five: Open and Closed Memories, Session Six: Forgiveness Session Seven: Maximizing versus Satisficing, Session Eight: Gratitude ,Session Nine: Hope and Optimism, Session Ten: Posttraumatic Growth, Session Eleven: Slowness and Savoring, Session Twelve: Positive Relationships, Session Thirteen: Positive Communication, Session Fourteen: Altruism , Session Fifteen: Meaning and Purpose | Behavioural | Positive Psychotherapy Group |
| Counseling GroupCaregivers in control group only regular counseling will be provided (psychoeducation). it will be based upon the insight of cerebral palsy and training based on Adaptive skill functioning of the CP child of the caregivers | Behavioural | Counseling Group |
Primary outcome
Change in Parental Burnout Assessment
Time frame: baseline and 8th week
a 23- item self-report questionnaire for assessment of Burn Out
Change in Depression Anxiety Stress Scale
Time frame: baseline and 8th week
DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress
Change in Caregiver Difficulties Scale
Time frame: baseline and 8th week
a self-administered questionnaire measure the caregiver burden
Change in Sense of Coherence
Time frame: baseline and 8th week
Measured by the orientation of life scale, It contains 13 items
Change in wellbeing Positive Psychotherapy Inventory
Time frame: baseline and 8th week
self-report inventory having 25 items.it assess level of mental wellbeing,
Change Multidimensional Scale of Perceived Social Support
Time frame: baseline and 8th week
Social support is measured across three domains; friends, family and significant others. The responses reflect participant's perception of support from each of these three sources
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- 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.
Rabia Mushtaq, PhD study director
International Islamic University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychotherapy and Counseling Group in people with Caregiver Burden and Mental Health Issue, run by International Islamic University, Islamabad at 1 site in Pakistan.
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 9 inclusion and 0 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 14 Nov 2022. 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 Pakistan. 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 Saima Waqar, PhD (00923334771117, samiwaqar23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parental Burnout Assessment (time frame: baseline and 8th week). The study lists 6 primary outcomes in all. 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 14 Nov 2022.