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Effectiveness of Positive Psychotherapy on Mental Wellbeing Among Caregivers of Cerebral Palsy Children

Primary Purpose

Caregiver Burden, Mental Health Issue, Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Positive Psychotherapy
Counseling Group
Sponsored by
International Islamic University, Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregiver Burden focused on measuring Positive psychotherapy, Sense of Coherence, Social support

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Rehabilitation MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Positive Psychotherapy Group

Counseling Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Parental Burnout Assessment
a 23- item self-report questionnaire for assessment of Burn Out
Change in Depression Anxiety Stress Scale
DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress
Change in Caregiver Difficulties Scale
a self-administered questionnaire measure the caregiver burden
Change in Sense of Coherence
Measured by the orientation of life scale, It contains 13 items
Change in wellbeing Positive Psychotherapy Inventory
self-report inventory having 25 items.it assess level of mental wellbeing,
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

Secondary Outcome Measures

Full Information

First Posted
October 28, 2022
Last Updated
November 4, 2022
Sponsor
International Islamic University, Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05613595
Brief Title
Effectiveness of Positive Psychotherapy on Mental Wellbeing Among Caregivers of Cerebral Palsy Children
Official Title
Effectiveness of Positive Psychotherapy on Mental Wellbeing, Sense of Coherence, Social Support and Difficulties Among Caregivers of Cerebral Palsy Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
January 12, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University, Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Mental Health Issue, Cerebral Palsy
Keywords
Positive psychotherapy, Sense of Coherence, Social support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive Psychotherapy Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Counseling Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychotherapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Counseling Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Parental Burnout Assessment
Description
a 23- item self-report questionnaire for assessment of Burn Out
Time Frame
baseline and 8th week
Title
Change in Depression Anxiety Stress Scale
Description
DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress
Time Frame
baseline and 8th week
Title
Change in Caregiver Difficulties Scale
Description
a self-administered questionnaire measure the caregiver burden
Time Frame
baseline and 8th week
Title
Change in Sense of Coherence
Description
Measured by the orientation of life scale, It contains 13 items
Time Frame
baseline and 8th week
Title
Change in wellbeing Positive Psychotherapy Inventory
Description
self-report inventory having 25 items.it assess level of mental wellbeing,
Time Frame
baseline and 8th week
Title
Change Multidimensional Scale of Perceived Social Support
Description
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
Time Frame
baseline and 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saima Waqar, PhD
Phone
00923334771117
Email
samiwaqar23@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Mushtaq, PhD
Organizational Affiliation
International Islamic University, Islamabad
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Rehabilitation Medicine
City
Islamabad
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farwah Ali

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Positive Psychotherapy on Mental Wellbeing Among Caregivers of Cerebral Palsy Children

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