ClinicalTrials.gg
Status unknownNCT05613595Updated Nov 14, 2022

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

An interventional study of Positive Psychotherapy and Counseling Group in Caregiver Burden, Mental Health Issue and Cerebral Palsy, sponsored by International Islamic University, Islamabad. Status unknown at 1 site in Pakistan. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by International Islamic University, Islamabad · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Nov 2021, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Caregiver Burden
  • Mental Health Issue
  • Cerebral Palsy

Keywords

  • Positive psychotherapy
  • Sense of Coherence
  • Social support
03

In context

Caregiver Burden

500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.

This study's planned enrollment of 20 is below the median of 71 across 402 interventional studies indexed under Caregiver Burden.

Browse Caregiver Burden studies →

Lead sponsor

International Islamic University, Islamabad is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

    Behavioral: Positive Psychotherapy

  • 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.

    Behavioral: Counseling Group

Interventions

  • BehavioralPositive Psychotherapy

    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

  • BehavioralCounseling Group

    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

06

What researchers measure

Primary outcomes

  1. Change in Parental Burnout Assessment

    a 23- item self-report questionnaire for assessment of Burn Out

    Time frame: baseline and 8th week

  2. Change in Depression Anxiety Stress Scale

    DASS is a self-report 21 items based questionnaire designed to measure depression, anxiety and stress

    Time frame: baseline and 8th week

  3. Change in Caregiver Difficulties Scale

    a self-administered questionnaire measure the caregiver burden

    Time frame: baseline and 8th week

  4. Change in Sense of Coherence

    Measured by the orientation of life scale, It contains 13 items

    Time frame: baseline and 8th week

  5. Change in wellbeing Positive Psychotherapy Inventory

    self-report inventory having 25 items.it assess level of mental wellbeing,

    Time frame: baseline and 8th week

  6. 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

    Time frame: baseline and 8th week

07

Study locations

1 of 1 sites recruiting
  • National Institute of Rehabilitation Medicine
    Islamabad, Pakistan
    Recruiting
    • Farwah Ali · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Jan 2023, 14 months after the start.

Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 14 months is below that.

Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2022
First posted
Nov 14, 2022
StartActual
Nov 11, 2021
Primary completionEst.
Jan 12, 2023
CompletionEst.
Aug 31, 2023
Last update
Nov 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05613595
Lead sponsor
International Islamic University, Islamabad
Responsible party
Saima Waqar (Principal Investigator, International Islamic University, Islamabad) — Principal investigator
First posted
Nov 14, 2022
Start date
Nov 11, 2021
Primary completion
Jan 12, 2023 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Nov 14, 2022

Study contacts

Saima Waqar, PhD
Contact
samiwaqar23@gmail.com
00923334771117
Rabia Mushtaq, PhD
study director · International Islamic University, Islamabad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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