The effectiveness of Individualised Homoeopathic Medicines in Adjustment Disorder with supportive couselling-A single blind randomised placebo controlled trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Cases will be assessed by using Depression Anxiety Stress Scale (DASS) to determine the severity of
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 12.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants who are diagnosed with adjustment disorder as per DSM 5 criteria Patients with Adjustment disorder new module 20(ADNM 20) score ≥ 47.5 Those who score 10 &above in the depression subscale,8 &above in the anxiety subscale , and 15&above in the stress subscale of DASS 21 Presence of a psychological stressor(score ≥ 1 ), at least one preoccupation and failure to adapt symptom, positive response of item 16, evidence of functional impairment(score ≥2) in International Adjustment Disorder Questionnaire(IADQ).
Exclusion Criteria
- •Patients with prolonged grief disorder Patients with acute stress reaction Patients with recurrent depressive disorder Patients with suicidal and homicidal tendencies.
- •Patients with postpartum depression Pregnant and lactating mother Patients with serious systemic illness Separation anxiety disorders of childhood.
Outcomes
Primary Outcomes
Cases will be assessed by using Depression Anxiety Stress Scale (DASS) to determine the severity of
Time Frame: Every 3rd month from baseline till the conclusion of study(6 month)
symptoms.
Time Frame: Every 3rd month from baseline till the conclusion of study(6 month)
Secondary Outcomes
- The severity of depression, anxiety, and stress will be compared(At baseline and)
Investigators
Dr Anupriya T
National Homoeopathy Research Institute in Mental Health,Kottayam