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Trial registered on ANZCTR


Registration number
ACTRN12616000381482
Ethics application status
Approved
Date submitted
23/07/2015
Date registered
23/03/2016
Date last updated
24/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness and cost effectiveness of Problem Management Plus (PM+) plus treatment as usual (TAU) vs. treatment as usual (TAU) in the management of common mental disorders in a tertiary mental health care facility in Pakistan: a single blind randomised controlled trial (RCT)
Scientific title
Effectiveness and cost effectiveness of Problem Management Plus (PM+) plus treatment as usual (TAU) vs. treatment as usual (TAU) in the management of common mental disorders in a tertiary mental health care facility in Pakistan: a single blind randomised controlled trial (RCT)
Secondary ID [1] 286990 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 295447 0
Anxiety 295448 0
Post-traumatic stress disorder (PTSD) 295449 0
common mental disorders 295693 0
Condition category
Condition code
Mental Health 295706 295706 0 0
Depression
Public Health 295707 295707 0 0
Health service research
Mental Health 296190 296190 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The name of the intervention is Problem Mangement Plus (PM+). It is a Cognitive Behaviour Therapy (CBT) based intervention for clients experiencing symptoms of depression and anxiety or any other stress related condition. PM+ is a trans-diagnositic, evidence-based intervention consisting of 5 weekly, individual face-to-face sessions and each session is for approximately 90 minutes. A designated psychologist trained in PM+ by the master trainer will deliver the 5 individual sessions to their designated client. These sessions will be based on discussion focusing on 4 strategies; managing stress, managing problems, get going keep doing, strengthening social support. The intervention group receives PM+ in addition to Treatment as usual (TAU). TAU consists of non-specific supportive counselling sessions and pharmacotherapy (antidepressants, anxiolytics, sedative and hypnotics etc) that clients receive at the tertiary mental healthcare facility. A register of attendance of the clients for their five PM+ sessions is being maintained.
Intervention code [1] 292194 0
Treatment: Other
Intervention code [2] 292612 0
Behaviour
Comparator / control treatment
TAU consists of non-specific supportive counselling sessions and pharmacotherapy (antidepressants, anxiolytics, sedative and hypnotics etc) that clients receive at the tertiary mental healthcare facility. The supportive counselling sessions usually comprise of one 20 minute session per client after the clinician has seen the client. These counselling sessions involve assessment procedures of depression and anxiety using Beck's Depression Inventory (BDI) and/or Beck's Anxiety Inventory (BAI) and a ten minute discussion based therapy.
Control group
Active

Outcomes
Primary outcome [1] 295463 0
Mean Hospital Anxiety and Depression Scale (HADS) score.
Timepoint [1] 295463 0
Baseline, at 7 weeks from randomisation and at 3 months after the 5th PM+ session.
Primary outcome [2] 295650 0
World Health Organisation Disability Assessment Schedule (WHODAS-12)
Timepoint [2] 295650 0
Baseline, at 7 weeks from randomisation and at 3 months after the 5th PM+ session.
Secondary outcome [1] 315617 0
Severity of depression as assessed using the Patient Health Questionnaire PHQ-9.
Timepoint [1] 315617 0
Baseline, at 7 weeks from randomisation and at 3 months after the 5th PM+ session.
Secondary outcome [2] 316108 0
PCL-5: PTSD symptoms.
Timepoint [2] 316108 0
Baseline, at 7 weeks from randomisation and at 3 months after the 5th PM+ session.
Secondary outcome [3] 316742 0
Health economics analysis will be conducted alongside the trial to determine the difference in costs and outcomes in the intervention arm as compared to the control arm.
We will take a broad perspective, including the public health sector and the societal perspective to capture full economic implications. This will include all direct cost of health, social, voluntary and private sector services used by the client as well as productivity losses of the client and caregivers, informal care and out-of-pocket expenses. Client Services Receipt Inventory (CSRI[I1] ) already translated and adapted for use in Pakistan will be used for data collection. Data will be collected at baseline, at 7 weeks and at 3 months follow-up assessment. The interview will be conducted by the team member un-blind to treatment allocation to avoid the risk of accidental un-blinding.
Primary analysis will be of total costs over the 3 months follow-up treatment period. Although cost data are often skewed, analyses will compare the mean costs in the two groups using standard t-test with ordinary least squares regression used for adjusted analyses and the validity of results confirmed using bootstrapping (ref[I2] , ref[I3] ). Subgroup analyses by baseline WHODAS score will be performed using tests of interaction.
Cost-effectiveness will be assessed by combining costs with the primary outcome measure in incremental cost-effectiveness analysis. In addition, repeat re-sampling from the costs and effectiveness data (bootstrapping) will be used to calculate the probability that each of the treatments is the optimal choice, subject to a range of possible maximum values (ceiling ratio) that a decision-maker might be willing to pay for a unit improvement in WHODAS score. A cost-effectiveness acceptability curve will be presented by plotting these probabilities for a range of possible values of the ceiling ratio (ref[I4] ) .
Finally, the relationship between costs and the remaining outcome measures will be explored individually in a cost consequences analysis, presenting the relationship between costs and consequences but without formal assessment of cost effectiveness.

1. Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B. Client socio-demographic and service receipt inventory–European version: development of an instrument for international research. EPSILON study 5. European psychiatric services: inputs linked to outcome domains and needs. Br J Psychiatry Suppl. 2000;39:s28–33.

[I2]Efron B, Tibshirani RJ (1993). An introduction to the bootstrap. New York: Chapman & Hall.

[I3]Barber JA, Thompson SG (1998). Analysis and interpretation of cost data in randomized control trials: review of published studies. British Medical Journal, 317, 1195-200.

[I4]Fenwick E, Claxton K,et al (2001). Representing uncertainty: the role of costeffectiveness acceptability curves. Health Economics, 10, 779-87.
Timepoint [3] 316742 0
Baseline, at 7 weeks from randomisation and at 3 months after the 5th PM+ session.

Eligibility
Key inclusion criteria
Clients of either gender will be included in the study, the age of participants from 18 to 60 years, GHQ score >2, and WHO DAS score > 16. GHQ-12 is the most extensively used screening instrument for common mental disorders, in addition to being a more general measure of psychiatric well-being, whereas, WHO DAS is a generic assessment instrument assessing health and disability.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
clients with severe mental disorder (for example, mania, seizures, psychosis, alcohol or drug-use dependence) and imminent suicide risk (Assessed using formal suicide risk assessment based on a WHO measure). reports of acute distress in the past month and clients that are residing outside of the study area and unable to attend for regular weekly PM+ sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
23/07/2015
Date of last participant enrolment
Anticipated
31/03/2016
Actual
20/08/2016
Date of last data collection
Anticipated
20/11/2016
Actual
Sample size
Target
192
Accrual to date
Final
192
Recruitment outside Australia
Country [1] 7012 0
Pakistan
State/province [1] 7012 0
Rawalpindi

Funding & Sponsors
Funding source category [1] 291628 0
Charities/Societies/Foundations
Name [1] 291628 0
Human Development Research Foundation
Country [1] 291628 0
Pakistan
Funding source category [2] 291629 0
Hospital
Name [2] 291629 0
Institute of Psychiatry,Benazir Bhutto Hospital.
Country [2] 291629 0
Pakistan
Primary sponsor type
Charities/Societies/Foundations
Name
Human Development Research Foundation
Address
House # 6, street # 55, F-7/4.
Islamabad.
Country
Pakistan
Secondary sponsor category [1] 290300 0
Hospital
Name [1] 290300 0
Institute of Psychiatry (IOP)Benazir Bhutto Hospital.
Address [1] 290300 0
Murree Road,
Rawalpindi
Country [1] 290300 0
Pakistan
Other collaborator category [1] 278540 0
Other Collaborative groups
Name [1] 278540 0
World Health Organisation Department of Mental Health
Address [1] 278540 0
Department of Mental Health and Substance Abuse, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland
Country [1] 278540 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293159 0
Rawalpindi Medical College
Ethics committee address [1] 293159 0
Ethics committee country [1] 293159 0
Pakistan
Date submitted for ethics approval [1] 293159 0
27/04/2015
Approval date [1] 293159 0
01/06/2015
Ethics approval number [1] 293159 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58410 0
Dr Syed Usman Hamdani
Address 58410 0
Syed Usman Hamdani
Institute of Psychiatry,
Rawalpindi.
Country 58410 0
Pakistan
Phone 58410 0
+92346 8544437
Fax 58410 0
Email 58410 0
[email protected]
Contact person for public queries
Name 58411 0
Miss Parveen Akhtar
Address 58411 0
Human Development Research Foundation House # 6, street # 55, F.7/4 Islamabad.
Country 58411 0
Pakistan
Phone 58411 0
Update +923135407345
Fax 58411 0
Email 58411 0
[email protected]
Contact person for scientific queries
Name 58412 0
Syed Usman Hamdani
Address 58412 0
Syed Usman Hamdani
Institute of Psychiatry,
Rawalpindi.
Country 58412 0
Pakistan
Phone 58412 0
+92346 8544437
Fax 58412 0
Email 58412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProblem 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.2017https://dx.doi.org/10.1186/s13033-017-0147-1
EmbaseEffect of adding a psychological intervention to routine care of common mental disorders in a specialized mental healthcare facility in Pakistan: a randomized controlled trial.2021https://dx.doi.org/10.1186/s13033-020-00434-y
N.B. These documents automatically identified may not have been verified by the study sponsor.