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Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal

Primary Purpose

Mental Disorders, Psychological Distress, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychosocial counselling
Enhanced Usual Care
Sponsored by
Centre for Victims of Torture, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 16
  • GHQ-12 ≥ 6
  • Willing to participate in the intervention and research program
  • Able to communicate fluently in Nepali and to participate the required visits
  • Resident in Dang for the subsequent 10 months

Exclusion Criteria:

  • Age < 16
  • GHQ-12 < 6
  • Signs of severe mental health problems (i.e., psychotic features)
  • Severe illnesses or conditions requiring immediate attentions( i.e., suicidal)
  • Not willing to participate in the intervention and research program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Psychosocial counselling + Enhanced usual care (EUC)

    Enhanced Usual Care (EUC)

    Arm Description

    This arm receives psychosocial counselling from the counsellor as well as enhanced usual care from health worker

    This arm receives enhanced usual care from health worker

    Outcomes

    Primary Outcome Measures

    The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory
    The range of scale is 0-63 scores and higher scores indicate higher levels of depression. Reduction of 50% or more from initial BDI score indicates response. The instrument is used at baseline, 1 month and 6 months in both groups.

    Secondary Outcome Measures

    Change in the symptoms of anxiety assessed by Beck Anxiety Inventory
    The range of scale is 0-63 scores and higher scores indicate higher levels of anxiety. The instrument is used at baseline, 1 month and 6 months in both groups.
    Change in the functional capacity assessed by World Health Organisation Disability Assessment Schedule - II
    The validated Nepali version of WHODAS-II includes 13 questions and the range of scale is 13-65 scores. Higher scores indicate lower level of functional capacity. The instrument is used at baseline, 1 month and 6 months in both groups.
    Change in the symptoms of depression assessed by Beck Depression Inventory
    The range of scale is 0-63 scores and higher scores indicate higher levels of depression. The instrument is used at baseline, 1 month and 6 months in both groups.

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    June 7, 2018
    Sponsor
    Centre for Victims of Torture, Nepal
    Collaborators
    Physicians for Social Responsibility, Finland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03544450
    Brief Title
    Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
    Official Title
    Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre for Victims of Torture, Nepal
    Collaborators
    Physicians for Social Responsibility, Finland

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment. The aim of this study is to assess the effectiveness of psychosocial counselling as practiced by non-medical psychosocial counsellors in improving the outcomes of persons with common mental disorders in a primary health care setting. Patients with psychosocial distress will be randomized to receive either counseling + enhanced usual care or enhanced usual care by health workers. The hypothesis is that adding psychosocial counselling to enhanced usual care, will be more effective than enhanced care alone in reducing the symptoms of depression, anxiety and posttraumatic stress disorder and in improving day-to-day functioning of clients receiving services in primary health care settings. If proven effective, non-medical health worker led counseling could be an affordable treatment to alleviate psychological suffering and improve functional capacity of Nepalese people.
    Detailed Description
    Statement of problem Psychosocial interventions, such as counselling, are effective in improving social functioning in common mental disorders. Specifically, culturally adapted psychological treatments are effective in the treatment of depression, according to a recent meta-analysis. Psychological treatments may be provided by non-medical health workers (NMHW) to increase accessibility. Task-shifting of screening and treatment of non-communicable diseases to non-medical health workers is both effective and cost-effective. A recent review included five randomized controlled trials to assess effectiveness of NMHW provided psychological interventions to treat common mental disorders and depression, and all five trials found the intervention beneficial over usual treatment. In the MANAS trial in India, for example, those receiving the intervention were 55% more likely to recover from common mental disorders than the control group in public health facilities. The stepped-care intervention was provided by NMHWs who had received a two-month training in counselling. In Pakistan, a psychological treatment delivered by Lady Health Workers (NMHWs) resulted in 78% reduction in maternal depression, compared with usual care. In Nepal, the need for psychosocial interventions led by NMHWs is high because of the very limited number of mental health professionals. Centre for Victims of Torture (CVICT) has extensive experience in developing psychosocial counseling services and training counsellors. CVICT has experienced that even a short intervention, including only 1-5 counselling sessions, leads to decreased mental distress. Positive feedback has been given both by the patients and the people working in primary health care. However, no rigorous research has been conducted on the effectiveness of counselling on the symptoms of common mental disorders. This will be the first study comparing the effectiveness of psychosocial counseling and enhanced usual care to enhanced usual in rural Nepal. Conceptual framework This trial will examine the added value of psychosocial counseling in individuals with psychological distress when provided together with enhanced usual care in rural health posts. The psychosocial approach emphasizes the close connection between psychological aspects of an individual's experience (namely, thoughts, feelings and beliefs) and the wider social experience (namely, relationships with family, community and friends) as well as the broader social environment (i.e. culture, traditions, religion, socio-political environment). There is a dynamic relationship between the psychological and social effects of experiences on the individual person, with each continually influencing the other. Psychosocial counselling starts with the complaints that a client brings into the session, and is aimed at decreasing disability. The client is assisted in dealing with problems himself/herself within a counselling process, or is sometimes referred to other existing resources if the counsellor feels that to be more appropriate. Specifically, the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up). This process helps to reduce psychological distress experienced by the patients and is practiced by trained psychosocial counselors. Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support). It is important to note that in this conceptual framework psychosocial counselling is just one part of the spectrum of psychosocial care and dealing with distress in Nepal's context where there are other issues such as poverty, human rights abuses, gender based violence etc. General objective To assess the effectiveness of psychosocial counseling as practiced by non-medical psychosocial counselors in improve the outcomes of persons with common health disorders in primary health care setting. Specific objective To assess the effectiveness of psychosocial counselling on: reducing symptoms of depression and anxiety improving functional capacity improving coping and use of available resources To assess acceptability of psychosocial counseling. Study variables Depressive symptoms, anxiety symptoms, coping mechanisms and usage of available resources, functional capacity Covariates: Demographic variable (gender, age, socioeconomic position) Study population Residents of Dang Study units Individuals Sampling methods As this is a randomized controlled trial, randomization will be done using a randomization table. Participants coming to the health post for treatment of symptoms of psychological distress will be potential participants for this research. Individuals referred by the counselors during their field mental health promotion work will also be potential participants for this research. Individuals will be screened with the General Health Questionnaire (GHQ-12, validated Nepali version, and those who score 6 or more on will be invited to participate in the study. The Research Assistant will use the GHQ. In the Nepali context, score of 6 or more in the GHQ-12 reveals psychological distress. The GHQ-12 was validated using Likert scale in Nepal. Randomization will be done by a health worker at the health post. Research Assistant will be blinded to the study. Sampling size A sample size of 132 in each group will be required to detect a clinically important difference of three points on the Beck scale of depression (BDI: Beck Depression Inventory), using a two-tailed test of the difference between means and a power of 80%, and a significance level of 5%. Based on a previous study, we assume a standard deviation of 8.7 for BDI and also the calculation is based on the assumption that the measurements on BDI are normally distributed. However, considering the possible 30% dropout rates, we will need to recruit 176 individuals per group, 352 in total. Data collection technique Data will be collected on paper and stored safely in lockers. No names will appear on study forms. All participants will be read out consent forms and asked to sign on the form. All questions of the data tools will be read aloud and participants will be asked to choose which level they agree with on Likert's scale. RA's data and counselors data will be kept separately. Study coordinator will enter data into SPSS bi-weekly. Participants will be referred by the project counselors, female community health volunteers and health workers of other health posts to the centres for study/ treatment. Data collection tools For the Quantitative study, questionnaires will be used to collect the data from each group. The questionnaire will have five sections. The sections are: Socio and Demographic information, Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), World Health Organization Disability Assessment Schedule-II (WHODAS-II) and Resource and Coping Mechanism will be used. All in all tools are validated in Nepal and study area (Dang), availed in Nepali language and used by CVICT in their previous Research.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorders, Psychological Distress, Depression, Anxiety, Coping

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    287 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychosocial counselling + Enhanced usual care (EUC)
    Arm Type
    Experimental
    Arm Description
    This arm receives psychosocial counselling from the counsellor as well as enhanced usual care from health worker
    Arm Title
    Enhanced Usual Care (EUC)
    Arm Type
    Active Comparator
    Arm Description
    This arm receives enhanced usual care from health worker
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychosocial counselling
    Intervention Description
    Individuals with psychological distress receive psychosocial counselling and enhanced usual care. The psychosocial the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up)." Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
    Intervention Type
    Other
    Intervention Name(s)
    Enhanced Usual Care
    Intervention Description
    Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
    Primary Outcome Measure Information:
    Title
    The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory
    Description
    The range of scale is 0-63 scores and higher scores indicate higher levels of depression. Reduction of 50% or more from initial BDI score indicates response. The instrument is used at baseline, 1 month and 6 months in both groups.
    Time Frame
    0 months, 1 month, 6 months
    Secondary Outcome Measure Information:
    Title
    Change in the symptoms of anxiety assessed by Beck Anxiety Inventory
    Description
    The range of scale is 0-63 scores and higher scores indicate higher levels of anxiety. The instrument is used at baseline, 1 month and 6 months in both groups.
    Time Frame
    0 months, 1 month, 6 months
    Title
    Change in the functional capacity assessed by World Health Organisation Disability Assessment Schedule - II
    Description
    The validated Nepali version of WHODAS-II includes 13 questions and the range of scale is 13-65 scores. Higher scores indicate lower level of functional capacity. The instrument is used at baseline, 1 month and 6 months in both groups.
    Time Frame
    0 months, 1 month, 6 months
    Title
    Change in the symptoms of depression assessed by Beck Depression Inventory
    Description
    The range of scale is 0-63 scores and higher scores indicate higher levels of depression. The instrument is used at baseline, 1 month and 6 months in both groups.
    Time Frame
    0 months, 1 month, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 16 GHQ-12 ≥ 6 Willing to participate in the intervention and research program Able to communicate fluently in Nepali and to participate the required visits Resident in Dang for the subsequent 10 months Exclusion Criteria: Age < 16 GHQ-12 < 6 Signs of severe mental health problems (i.e., psychotic features) Severe illnesses or conditions requiring immediate attentions( i.e., suicidal) Not willing to participate in the intervention and research program

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21159375
    Citation
    Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, De Silva MJ, Bhat B, Araya R, King M, Simon G, Verdeli H, Kirkwood BR. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010 Dec 18;376(9758):2086-95. doi: 10.1016/S0140-6736(10)61508-5. Epub 2010 Dec 13.
    Results Reference
    background
    PubMed Identifier
    16114588
    Citation
    Tol WA, Jordans MJ, Regmi S, Sharma B. Cultural challenges to psychosocial counselling in Nepal. Transcult Psychiatry. 2005 Jun;42(2):317-33. doi: 10.1177/1363461505052670.
    Results Reference
    background

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    Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal

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