Depression Clinical Trial
Official title:
Effectiveness of Non-medical Health Worker (NMHW) Led Counseling on Common Mental Disorders in Rural Mid-western Nepal
NCT number | NCT03544450 |
Other study ID # | CounselingCvict |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | December 2017 |
Verified date | June 2018 |
Source | Centre for Victims of Torture, Nepal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 287 |
Est. completion date | December 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre for Victims of Torture, Nepal | Physicians for Social Responsibility, Finland |
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. — View Citation
Tol WA, Jordans MJ, Regmi S, Sharma B. Cultural challenges to psychosocial counselling in Nepal. Transcult Psychiatry. 2005 Jun;42(2):317-33. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 0 months, 1 month, 6 months | |
Secondary | 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. | 0 months, 1 month, 6 months | |
Secondary | 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. | 0 months, 1 month, 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
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
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |