CTRI/2018/05/013600
Completed
Phase 1
“Feasibility and Effectiveness of Family Intervention Addressing Expressed Emotions in Recipients of Opioid Substitution Therapy: A Randomised Controlled Studyâ€
All India Institute Of Medical Sciences1 site in 1 country120 target enrollmentStarted: March 4, 2017Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- There will be decrease in expressed emotions of family members with six session of family interventions
Overview
Brief Summary
The primary purpose of the study was to assess the feasibility and effectiveness of family intervention addressing expressed emotions of family members of recipients of opioid substitution therapy.The first objective was achieved.The first hypothesis that there will be decrease in expressed emotions with family interventions was also accepted.Further with high EE there was increased family burden and low quality of life.With decrease in expressed emotions there was decrease in burden and increase in quality of life.
To conclude the component of cognitive behaviour family therapy were able to address high expressed emotions of family members and family interventions were found to be feasible to carry out for the same.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects 1Male patients 2Age range of 18-60 years 3Initiated on buprenorphine maintenance treatment for minimum of two weeks and maximum of 4 Weeks Family Member 1Related by blood or marriage and living with the patient in the same house since at least past one year 2Age range from 18-60 years (either gender) 3Living with the subject for at least past one year and will be with the patient during the course of the study period 4Score >54 on Family Attitude Scale, corresponding to ‘high’ EE 5Informed consent for interview and intervention 6Informed consent for self and family interview and intervention.
Exclusion Criteria
- •Subject 1Individuals dependent on other psychoactive substances (except tobacco) in the past three months 2Any serious medical illness which may interfere with interview process 3Any psychiatric illness which may interfere with interview process• Family Member 1 Any serious medical illness or psychiatric illness(including substance use disorders) which may interfere with interview process 2Have received structured psychological intervention family intervention in past one year.
Outcomes
Primary Outcomes
There will be decrease in expressed emotions of family members with six session of family interventions
Time Frame: 6 weekly session in 8-10 weeks time
Secondary Outcomes
- There will be decrease in burden of family members in post assessment after intervention(6 week sessions in 8-10 weeks time)
- There will be improvement in QOL of family members post assessment(6 weeks session within 6-8 weeks time)
- There will be improvement of perceived critic of patients towards family members(6 weekly session within 8-10 weeks time)
- There will be improvement in QOL of patients post intervention(6 weekly sessions within 8-10 weeks time)
Investigators
Study Sites (1)
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