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

NCT03544450 | Completed

• 1 other identifier: CounselingCvict
• Study Type: interventional
• Target: 287
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Disorders; Psychological Distress; Depression; Anxiety; Coping

Outcome Measures

Primary Outcomes (1)

• 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.

  0 months, 1 month, 6 months

Secondary Outcomes (3)

• Change in the symptoms of anxiety assessed by Beck Anxiety Inventory

  0 months, 1 month, 6 months

• Change in the functional capacity assessed by World Health Organisation Disability Assessment Schedule - II

  0 months, 1 month, 6 months

• Change in the symptoms of depression assessed by Beck Depression Inventory

  0 months, 1 month, 6 months

Study Arms (2)

Psychosocial counselling + Enhanced usual care (EUC)

EXPERIMENTAL

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

Behavioral: Psychosocial counselling; Other: Enhanced Usual Care

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

This arm receives enhanced usual care from health worker

Other: Enhanced Usual Care

Interventions

Psychosocial counselling BEHAVIORAL

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).

Psychosocial counselling + Enhanced usual care (EUC)

Enhanced Usual Care OTHER

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).

Enhanced Usual Care (EUC); Psychosocial counselling + Enhanced usual care (EUC)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Victims of Torture, Nepal: lead
• Physicians for Social Responsibility, Finland: collaborator

Related Publications (2)

• 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.

  PMID: 21159375 BACKGROUND

• 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.

  PMID: 16114588 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: June 1, 2018
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 11, 2018

Record last verified: 2018-06