Community Based Psychological Intervention for Persons Living with Disabilities

NCT ID: NCT04981522

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2022-12-15

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Physical Condition, Minor Psychological Component Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Research design of the study shall consists of two-arms, single-blind cluster randomized controlled trial (c-RCT). While Randomized Control Trial (RCT) shall consists of two groups: Active Treatment (AT) and Delayed Treatment Control (DTC).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Single-blind cluster randomized controlled trial (c-RCT)

Study Groups

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Active Treatment (AT): PM+ intervention

Active Treatment (AT) group will receive 05 sessions of indigenously adapted problem management plus (IA-PM+) intervention.

Group Type EXPERIMENTAL

Indigenously adapted problem management plus (IA-PM+)

Intervention Type 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.

Delayed Treatment Control (DTC): Treatment as usual

Delayed Treatment Control (DTC) group will receive routine treatment until the last follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Indigenously adapted problem management plus (IA-PM+)

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Problem management plus (PM+)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aid To Leprosy Patients (ALP), Rawalpindi-Pakistan

UNKNOWN

Sponsor Role collaborator

International Islamic University, Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Basharat Hussain

Lecturer/PhD Scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Muhammad Tahir Khalily, PhD

Role: STUDY_CHAIR

International Islamic University, Islamabad

Locations

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

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Hamdani SU, Ahmed Z, Sijbrandij M, Nazir H, Masood A, Akhtar P, Amin H, Bryant RA, Dawson K, van Ommeren M, Rahman A, Minhas FA. Problem Management Plus (PM+) in the management of common mental disorders in a specialized mental healthcare facility in Pakistan; study protocol for a randomized controlled trial. Int J Ment Health Syst. 2017 Jun 8;11:40. doi: 10.1186/s13033-017-0147-1. eCollection 2017.

Reference Type BACKGROUND
PMID: 28603552 (View on PubMed)

Some D, Edwards JK, Reid T, Van den Bergh R, Kosgei RJ, Wilkinson E, Baruani B, Kizito W, Khabala K, Shah S, Kibachio J, Musembi P. Task Shifting the Management of Non-Communicable Diseases to Nurses in Kibera, Kenya: Does It Work? PLoS One. 2016 Jan 26;11(1):e0145634. doi: 10.1371/journal.pone.0145634. eCollection 2016.

Reference Type BACKGROUND
PMID: 26812079 (View on PubMed)

Iemmi, V., Gibson, L., Blanchet, K., Kumar, K. S., Rath, S., Hartley, S., . . .Kuper, H. (2014). Community-based rehabilitation for people with disabilities in low-and middle-income countries: A systematic review. Campbell Systematic Reviews, 11(1), 1-177.

Reference Type BACKGROUND

Hussain B, Khalily MT, Hallahan B. Psychological intervention for a person living with amblyopia: a case study from home-based integrated care. J Pak Med Assoc. 2023 Jun;73(6):1330-1333. doi: 10.47391/JPMA.7304.

Reference Type BACKGROUND
PMID: 37427645 (View on PubMed)

Hussain, B., & Khalily, M. T. (2024). Enhancing Community Resilience: integrated home-based psychological intervention for individuals living with physical disabilities. Journal of Professional & Applied Psychology, 5(1)

Reference Type BACKGROUND

Hussain, B., Khalily, M. T., & Zaman, S. (2024). Integrated Psychological Intervention for Amelioration of Mental Health Problems of Individuals with Physical Disabilities in Pakistan. Al-Qirtas, 3(1), 159-167.

Reference Type BACKGROUND

Hussain B, Khalily MT, Waqas A, Rahman A, Angelakis I, Nisar A, Zaman S, Akhtar T. Acceptability and efficacy of the culturally adapted problem management plus intervention for people with disability in Pakistan: a pilot cluster randomized controlled trial. Front Psychiatry. 2025 Jan 30;15:1413809. doi: 10.3389/fpsyt.2024.1413809. eCollection 2024.

Reference Type DERIVED
PMID: 39980593 (View on PubMed)

Related Links

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Other Identifiers

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64-FSS/PHDPSY/F18

Identifier Type: -

Identifier Source: org_study_id

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