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Completed

NCT Number: NCT04981522

Community Based Psychological Intervention For Persons Living With Disabilities

Mental health problems are increasing in Pakistan and there is a 90% treatment gap in mental health services. Accessibility towards mental health services is limited due to range of factors including low income and resources, lack of the trained staff and lack of specialized and non-specialized mental health facilities. Therefore, there is a dire need to develop indigenous solution of the mental health issues grounded in Islamic teaching.

In this regard this study is designed to address the mental health issues at community level. Therefore, this study divided into two phases. In first phase the aim of the study is to adapt World Health Organization recommended psychological intervention for paraprofessionals and to train the paraprofessional on this indigenously adapted intervention. Subsequently, in second phase the study aims to assess the effectiveness of the indigenously adapted Problem Management Plus (IA-PM+) as an evidence based remedy in the treatment of psychological distress of person living with disabilities (PWDs).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Based Inclusive Development (CBID) Center, Basic Health Unit (BHU) Kuri Dolal

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

Prevalence of disability is higher in Low and middle income countries (LMICs). Persons living with disabilities are more vulnerable to develop psychopathology due to their low level of functioning, their complex and specific needs. Consequently, Persons living with disabilities (PWDs) are expected to experience more adverse psychological ailments as compared to the persons living without disabilities particularly in the rural parts of the countries. Accessibility towards mental health services in Pakistan has been limited due to range of factors including low income and resources, lack of the trained staff and lack of specialized and non-specialized mental health facilities. These challenges are required to be dealt at locally at micro and macro levels systemically and effectively. This requires development and innovation in the existing infrastructure by devising multidisciplinary community based treatment policy in building mental health care services. Therefore, to integrate the mental health care services at primary care level, there is a dire need to develop indigenous psychological interventions in a simplified form so that people can quickly learn their utilization not only from the health professionals but also from the para-professionals as well.

Due to the lack of specialized mental health services and human resources in low resource settings, task shifting is a well-known strategy, designed by World Health Organization to bridge the treatment gap in mental health problems. This strategy empowers the health workers, such as nurses and non-specialist to perform specific roles to bridge the available treatment gap. In addition to this, deliverance of evidence based psychological treatment by para-professionals/ non-specialists will not only help in reducing the financial and human resources but also might be able to reduce the stigma associated with mental illness.

Realizing the influence of religion on the general population, the American Psychological Association (APA) has recommended to view the religion as a significant aspect of human life and as such psychologists need to get special knowledge and training on religious psychotherapy.

In this regard this study is designed to address the mental health issues at community level. Therefore, this study divided into two phases. In first phase the aim of the study is to adapt World Health Organization recommended psychological intervention for paraprofessionals and to train the paraprofessional on this indigenously adapted intervention. Subsequently, in second phase the study aims to assess the effectiveness of the indigenously adapted Problem Management Plus (IA-PM+) as an evidence based remedy in the treatment of psychological distress of person living with disabilities (PWDs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Score more than 16 (16>) On PSYCHLOPS
  • Participants living with permanent disabilities (more than 6 months)

Exclusion criteria

  • Temporary resident or people living outside the study area.
  • Participants who are unable to engage or respond to the research question
  • Diagnosed psychiatric patients

Treatment and study plan

Indigenously adapted problem management plus (IA-PM+)

Behavioral

The IA-PM+ manual would be comprised of the following evidence-based techniques: (a) problem solving, (b) stress management, (c) behavioral activation and (d) accessing social support. The IA-PM+ intervention consisting of five sessions, will teach the participants techniques to manage their emotional problems.

Other names: Problem management plus (PM+)

Primary outcomes

  1. WHO Disability Assessment Scale (WHODAS 2.0)

    Time frame: Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline. The purpose of the outcome measure is to asses the change from baseline to follow-up.

    WHODAS 2.0 is a self-report instrument is used to assess health and disability. The WHODAS assess people's difficulties associated to their illness across six domains of functioning (mobility, cognition, self-care, getting along, life activities and participation). Its five-point Likert scale keeps record of the last 30 days. The 12-item WHODAS 2.0 version translated in Urdu will be used in this study. (World-Health-Organization, 2010).

  2. Depression Anxiety Stress Scale (DASS-21)

    Time frame: Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline. The purpose of the outcome measure is to asses the change from baseline to follow-up.

    DASS is a 21 items Likert-scale is used to assess the possibility of depression, anxiety and stress among the study population (Lovibond & Lovibond, 1995).

Secondary outcomes

  1. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline.

    MSPSS measures perceived social support. Its seven point Likert scale, includes 12 items that cover three dimensions: family, friends and other significant.

  2. Satisfaction with Life Scale (SWLC)

    Time frame: Assessments will be conducted at baseline (after the screening), 8th week (2 month) after the baseline, 20th week (5th month) after the baseline.

    Satisfaction with Life Scale (SWLC) is a 5-item scale designed to measure the global cognitive judgements of one's life satisfaction.

  3. Client Satisfaction Questionnaire (CSQ)

    Time frame: The questionnaire will be employed on the 8th week (2 month) after the baseline and at the 20th week (5th month) after the baseline.

    The Client Satisfaction Questionnaire is a brief and simple scale to measure the patient satisfaction with mental health services.

Sponsors and collaborators

Lead sponsor

International Islamic University, Islamabad

Other

Collaborators

  • Aid To Leprosy Patients (ALP), Rawalpindi-Pakistan

Registry information

Official study title

Indigenously Adapted Community Based Psychological Intervention For Individuals Living With Disabilities: A Cluster Randomized Clinical Trial

Acronym: CBPI-PWD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2021
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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