Community Based Psychological Intervention for Persons Living with Disabilities

NCT04981522 | Completed DMC

• 1 other identifier: 64-FSS/PHDPSY/F18
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Physical Condition, Minor Psychological Component; Psychological Distress

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

• 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).

  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 (3)

• Multidimensional Scale of Perceived Social Support (MSPSS)

  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)

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

• Client Satisfaction Questionnaire (CSQ)

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

Study Arms (2)

Active Treatment (AT): PM+ intervention

EXPERIMENTAL

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+)

Delayed Treatment Control (DTC): Treatment as usual

NO INTERVENTION

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

Interventions

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.

Also known as: Problem management plus (PM+)

Active Treatment (AT): PM+ intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• International Islamic University, Islamabad: lead
• Aid To Leprosy Patients (ALP), Rawalpindi-Pakistan: collaborator

Study Sites (1)

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

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 28603552 BACKGROUND

• 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.

  PMID: 26812079 BACKGROUND

• 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.

  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.

  PMID: 37427645 BACKGROUND

• 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)

  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.

  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.

  PMID: 39980593 DERIVED

Related Links

• Related Info

Study Officials

• Dr. Muhammad Tahir Khalily, PhD

  International Islamic University, Islamabad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Single-blind cluster randomized controlled trial (c-RCT)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer/PhD Scholar

Model Details: 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).

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: July 19, 2021
• Primary Completion: September 12, 2022
• Study Completion: December 15, 2022
• Last Updated: January 15, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)