ClinicalTrials.gg
CompletedNCT04981522CBPI-PWDUpdated Jan 15, 2025

Community Based Psychological Intervention for Persons Living with Disabilities

An interventional study of Indigenously adapted problem management plus (IA-PM+) in Physical Condition, Minor Psychological Component and Psychological Distress, sponsored by International Islamic University, Islamabad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-15.

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

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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).

Read the detailed description

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).

02

Conditions studied

  • Physical Condition, Minor Psychological Component
  • Psychological Distress
03

In context

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
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    Active Treatment (AT): PM+ intervention

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

    Behavioral: Indigenously adapted problem management plus (IA-PM+)

  • No intervention
    Delayed Treatment Control (DTC): Treatment as usual

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

Interventions

  • BehavioralIndigenously 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.

    Also known as: Problem management plus (PM+)

06

What researchers measure

Primary outcomes

  1. WHO Disability Assessment Scale (WHODAS 2.0)

    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).

    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.

  2. Depression Anxiety Stress Scale (DASS-21)

    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).

    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.

Secondary outcomes

  1. Multidimensional Scale of Perceived Social Support (MSPSS)

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

    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.

  2. Satisfaction with Life Scale (SWLC)

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

    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.

  3. Client Satisfaction Questionnaire (CSQ)

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

    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.

07

Study locations

1 site
  • Community Based Inclusive Development (CBID) Center, Basic Health Unit (BHU) Kuri Dolal
    Rawalpindi, Punjab 46000, Pakistan
08

References and documents

Publications

  • 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. Erratum In: Int J Ment Health Syst. 2018 Sep 27;12:53. doi: 10.1186/s13033-018-0231-1. PubMed 28603552 ↗
  • 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. PubMed 26812079 ↗
  • 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.
  • 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. PubMed 37427645 ↗
  • 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)
  • 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.

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04981522
Lead sponsor
International Islamic University, Islamabad
Collaborators
Aid To Leprosy Patients (ALP), Rawalpindi-Pakistan
Responsible party
Basharat Hussain (Lecturer/PhD Scholar, International Islamic University, Islamabad) — Principal investigator
First posted
Jul 29, 2021
Start date
Jul 19, 2021
Primary completion
Sep 12, 2022
Completion
Dec 15, 2022
Last update
Jan 15, 2025

Study contacts

Dr. Muhammad Tahir Khalily, PhD
study chair · 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 completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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