A Randomized controlled trial on the effectiveness of nurse led brief intervention to reduce risky use of psychoactive substance among members in the selected elderly organization of rohtak

Title:- A Randomized Controlled Trial on the effectiveness of nurse led brief intervention to reduce risky use of psychoactive substance among members in the selected elderly organization of Rohtak.

·      Date collection method (plan for data collection):

The study will be conducted in 2 phases. The purpose of Phase I is to screen the subjects for moderate and high risk of substance use involvement (“screen positive†subjects) in order to obtain the requisite sample for the next phase.  The Phase II of the study will randomize the screen positive subjects to either ASSIST-linked BI (Intervention Group) or to non-specific general advice (Control Group).

In the Phase II of the study, Screen positive subjects (Moderate and High Risk) will be first administered the other research instruments (Socio-Demographic Performa, Clinical Performa, PHQ-4). After this, they will be randomized into Intervention group and control group.

**Randomization:**Block randomization will be used and equal numbers of participants into each group (intervention & control groups)

**Allocation concealment:**Allocation concealment will be ensured by using sequentially numbered sealed envelopes.  Following the written informed consent, the nurse will open a sealed envelope which will reveal the treatment allocation and the allocation in these envelopes will be determined by block-randomization process.

**Blinding:**The study will be a single blinded study in which those who conduct follow-up assessment will be blinded to treatment allocation.

After randomization, the Intervention group will be administered WHO ASSIST-linked BI package (approx.15-30 min single session). Brief Intervention is based on Motivational interviewing and FRAMES Model. It is a structured therapy of short duration (15- 30 minutes) is offered with an aim to help a person to reduce the use of substance. Session consists of discussing individualized harmful consequences of using substance, establishing clear link between substance consumption and the consequences, emphasizing the patient’s personal responsibility to change, evaluation of high risk situations, implementation of alternative highs, advice on coping strategies with facilitating self-efficacy and optimism. During intervention subjects will also be offer options to consult various treatment centre if they are in need.