Family Counselling for Opioid Addiction

Not yet recruiting

Conditions: Opioid dependence,

Registration Number: CTRI/2024/01/062107

Lead Sponsor: AIIMS New Delhi

Brief Summary: Aim - To compare the change in family functioning of patients and family members who receive family intervention, to treatment as usual in patients with opioid use disorder.

Objectives - To compare the change in family functioning of the family intervention group with the control group.

To compare the change of opioid use in the family intervention group with the control group.

To ascertain the therapist, patient and family memberâ€™s perspectives on family

Rationale - Family members in India are often involved in the treatment and their wishes are an important factor in the decision making and treatment process. They provide support for treatment of the substance user in many ways. There is sufficient evidence for involving family members for the treatment of patients with substance use disorders. Psychological interventions have been found to be useful for treatment of opioid use disorders. Intervention with family members, in the Indian context, can be a helpful approach to provide treatment to patients with opioid use disorder.

Procedure:

Screening will be performed to recruit patients with opioid use disorder registeredatNDDTC OPD. The purpose of screening is to assess the suitability of the patient for inclusion in this study based on the inclusion criteria. The patients meeting the recruitment criteria for the study will be informed about the aims and objectives of the research, study procedures, nature of participation and rights of the study participants. If the patient is willing to participate in the study after receiving adequate information, he would be invited to sign the consent form for the study which is available in both English and Hindi. A detailed assessment of the subjects recruited into the study will be performed on the 1st day only after taking written informed consent. The patients would be randomized to either of the study arms by the simple random allocation (1:1). Computerized random sequences would be generated and allocated into group A (Intervention group) or B (Control group). Intervention would comprise of sessions with family members (up to 3), conducted over a period of 4 weeks. Assessments of both of the groups would be conducted using Maudsley Addiction Profile at Week 4 and 8. At week 12, assessment will be done with Family Assessment Device and Maudsley Addiction Profile.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

For patients: Diagnosis of opioid dependence syndrome In early phase of maintenance treatment, either buprenorphine or naltrexone (initiated within 3 months) Willing to engage in the intervention Access to phone For family members: 1.Family member staying with the patient 2.Aged 18 and above 3.Planning to stay with the patient during the course of intervention and willing to participate in the family intervention 4.Patient willing to participate with the particular member in the intervention.

Exclusion Criteria

For patients 1.Exposure to any structured psycho-social intervention for opioid use 2.Those who are intoxicated or in severe withdrawal which precludes an interview 3.Currently suffering from a psychotic illness 4.Psychiatric or medical comorbidity that precludes an interview For family members 1.Suffering from any substance use disorder except tobacco use disorder 2.Psychiatric or medical comorbidity that precludes an interview.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the change in family functioning of the family intervention group with the control group as measured on Family assessment device.	At 0 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the change of opioid use in the family intervention group with the control group.	Baseline, 4 weeks, 8 weeks, 12 weeks
To ascertain the therapist, patient and family memberâ€™s perspectives on family intervention	after sessions

Trial Locations

Locations (1): AIIMS
🇮🇳
South, DELHI, India
AIIMS
🇮🇳South, DELHI, India
Dr Yesh Chandra Singh
Principal investigator
9458253089
yeshsingh91@gmail.com