The effectiveness of Individualised Homoeopathic Medicines in Adjustment Disorder with supportive couselling-A single blind randomised placebo controlled trial

This study is a randomized, single-blind placebo-controlled trial comparing individualized homoeopathic medicine and placebo with supportive counselling for 18 months(12 months enrollment and 6 months follow-up), and will be conducted in OPD,IPD and peripheral units of Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. Patients shall be screened for adjustment disorder with a verbal screening questionnaire prepared using DSM 5 Diagnostic Criteria. The detailed screening was done by the principal investigator by using Adjustment Disorder New Module 20(ADNM 20). After the screening, probable diagnosis is done by using IADQ(International Adjustment Disorder Questionnaire) and DASS 21(Depression Anxiety Stress) scale. The consultant Psychiatrist will confirm the diagnosis. After enrollment, each patient will be assigned to either group A (homeopathic medicine with supportive counseling) or group B (placebo with supportive counseling) as intervention through random numbers. Following inclusions, patients will receive a prescription of the individualized homoeopathic medicine and placebo according to a randomized assignment sequence to either homeopathy or placebo group generated by using online randomization tools. The patients were randomly assigned in a 1:1 ratio to receive either individualized homoeopathic medicine or placebo using a Simple randomization procedure. Framing up the symptom totality,repertorisation will be done by using the appropriate repertory as per the requirement of the case. The final selection of the medicine will be done after comparing it with homeopathic materia medica.The potency, dose, and frequency of repetition will be determined according to the homoeopathic principles.Cases will be assessed at baseline Depression Anxiety Stress Scale (DASS) to determine the severity of the condition. The outcome of treatment will be assessed according to Depression Anxiety Stress Scale( DASS)-21 items, at the 3rd,6th, 9th, and 12th months. The severity of depression, anxiety, and stress will be compared at baseline and end of treatment.