Depression Clinical Trial
Official title:
Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |