- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613595
Effectiveness of Positive Psychotherapy on Mental Wellbeing Among Caregivers of Cerebral Palsy Children
Effectiveness of Positive Psychotherapy on Mental Wellbeing, Sense of Coherence, Social Support and Difficulties Among Caregivers of Cerebral Palsy Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saima Waqar, PhD
- Phone Number: 00923334771117
- Email: samiwaqar23@gmail.com
Study Locations
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Islamabad, Pakistan
- Recruiting
- National Institute of Rehabilitation Medicine
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Contact:
- Farwah Ali
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Inclusion Criteria
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Positive Psychotherapy Group
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
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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 |
Active Comparator: Counseling Group
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parental Burnout Assessment
Time Frame: baseline and 8th week
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a 23- item self-report questionnaire for assessment of Burn Out
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baseline and 8th week
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Change in Depression Anxiety Stress Scale
Time Frame: baseline and 8th week
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DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress
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baseline and 8th week
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Change in Caregiver Difficulties Scale
Time Frame: baseline and 8th week
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a self-administered questionnaire measure the caregiver burden
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baseline and 8th week
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Change in Sense of Coherence
Time Frame: baseline and 8th week
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Measured by the orientation of life scale, It contains 13 items
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baseline and 8th week
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Change in wellbeing Positive Psychotherapy Inventory
Time Frame: baseline and 8th week
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self-report inventory having 25 items.it
assess level of mental wellbeing,
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baseline and 8th week
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Change Multidimensional Scale of Perceived Social Support
Time Frame: baseline and 8th week
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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
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baseline and 8th week
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Collaborators and Investigators
Investigators
- Study Director: Rabia Mushtaq, PhD, International Islamic University, Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60-FSS/PHDPSY/F18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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