A Study of Weekly Brief Telephonic Intervention in patients with Alcohol Dependence
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The patients of alcohol dependence receiving brief telephonic intervention will have greater cumulative abstinence duration( total number of days abstinent from alcohol) compared to those not receiving it.
Study Overview
Brief Summary
Alcohol use disorder is chronic psychiatric illness associated with high rates of relapse. Treatment retention and adherence to medication is a huge problem in the health care system. Poor adherence can only lead to the worsening of the disease and increase the costs and resources taken up by the hospitals as patients who adhere poorly to the treatment tend to visit the hospitals more often to seek treatment. As a result, it becomes extremely important to identify and tackle the problem in the most effective way. There have been numerous studies done in the west that have proven that reminders in form of text messages and through various mobile apps have improved treatment adherence not only in case of alcohol dependence but also in other illnesses that require long term treatment. There is a paucity of research on this strategy from India. Besides, the effectiveness of regular telephonic reminders in AUD is less researched .
All the Participants aged 18 to 60 years attending adult psychiatry OPD and addiction treatment clinic OPD will be screened and first 3 subjects fulfilling the selection criteria will be enrolled in the study. Study information will be provided to patients and informed consent will be obtained. Diagnosis will be ascertained and psychiatric co-morbidities will be ruled out clinically, using ICD-11. At baseline, semi-structured questionnaire will be used to collect information about sociodemographic data concerning family, social, psychological, medical, and legal problems and history of substance use pattern. Patients will be randomized using computer generated random table method into Intervention and Control group and allocation concealment will be done using sealed envelope method. Clinical Institute Withdrawal Assessment for Alcohol (CIWA- Ar ), Alcohol use disorder identification test (AUDIT) ,Visual analogue scale (VAS) , WHO-QoL BREF and WHO well-being scale will be applied in both groups at baseline. The intervention group will receive a brief telephonic intervention every week for 8 weeks and they will be assessed for Lapse, Relapse, or any challenges related to medication adherence. The Brief intervention given via telephone will explore circumstances leading to lapse, relapse, provide supporting statements, address issues with treatment adherence and reminder for next follow up will be given. The control group will not receive any telephonic intervention and will only receive treatment as usual. Assessment will be performed in person at Department of Psychiatry, KGMU in both the groups at 2, 4 and 8 weeks that will include assessing Quality of life using WHO QOL-Bref and WHO well-being scale, lapses , relapses, No of days alcohol consumed and amount using Timeline follow back ( TLFB ) ,Dropouts, Medication adherence ( Self/ Family reported adherence to medication) ,Craving using Visual Analogue Scale. The study will be continued for patients who had a lapse but who did not relapse. At the end of study Cumulative abstinence duration will be measured in both groups. Intention to treat analysis will be done and for missing data, Last Observation Carried Forward(LOCF) will be used. Data collected will be statistically analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients who are willing to give informed consent.
- •2.Diagnosis of alcohol dependence as per ICD-
- •3.Age between 18 and 60 years.
- •4.Clinical Institute Withdrawal Assesment of Alcohol Scale, Revised score less than 8.
Exclusion Criteria
- •1.A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorder 2.Patients who cannot be contacted telephonically.
- •3.Presence of comorbid physical illnesses that preclude their participation into the study 4.Use of alcohol within last 7 days.
Outcomes
Primary Outcomes
The patients of alcohol dependence receiving brief telephonic intervention will have greater cumulative abstinence duration( total number of days abstinent from alcohol) compared to those not receiving it.
Time Frame: 2 , 4 and 8 weeks.
Secondary Outcomes
- Difference in Cumulative abstinence duration( total number of days abstinent from alcohol)(Difference in quality of life between groups)
Investigators
Shobhit Nain
King George Medical University
