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)

INTERVENTION: 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. CONDITION: Anxiety common mental disorders Depression Post‐traumatic stress disorder (PTSD) PRIMARY OUTCOME: Mean Hospital Anxiety and Depression Scale (HADS) score. World Health Organisation Disability Assessment Schedule (WHODAS‐12) SECONDARY OUTCOME: 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] ) . ; ; ; [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. ; ; 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. ; [I4]Fenwick E, Claxton K,et al (2001). Representing uncertainty: the role of costeffectiveness acceptability curves. Health Economics, 10, 779‐87. PCL‐5: PTSD symptoms. Severity of depression as assessed using the Patient Health Questionnaire PHQ‐9. 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.