Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking- Randomised Controlled Pilot Trials
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|ClinicalTrials.gov Identifier: NCT02327858|
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : August 8, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Depression Alcoholism||Other: Supportive text messages||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking in Patients With Primary Depression or Alcohol Use Disorder - Randomised Controlled Pilot Trials|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Supportive text message group
Patients in all the intervention groups will receive twice daily supportive SMS text messages for 3 months .
Other: Supportive text messages
Patients in all the intervention groups will receive twice daily supportive SMS text messages for 3 months. The messages will be tailored towards improving mood, compliance with medication or targeting abstinence from alcohol in accordance with the primary aims of our study. As far as possible, the majority of the text messages will reflect lessons patients usually learn during CBT and addiction counselling sessions.
No Intervention: No supportive text message group
Patients in the control group will only receive a text message once every two weeks thanking them for participating in the study. The aim of this will be to help increase the retention rate for the study.
- Mean changes in the BDI scores from baseline for those with a primary diagnosis of Depression [ Time Frame: 3 Months ]
- Cumulative Abstinence Duration from baseline (Since discharge from the Residential Addiction treatment programme) for those with AUD. [ Time Frame: 3 Months ]
- Mean units of alcohol per drinking days for participants with AUD [ Time Frame: 3 Months ]
- Mean Days to first drink for participants with AUD [ Time Frame: 3 Months ]
- Number of hazardous drinking days from baseline for participants with AUD [ Time Frame: 3 Months ]
- Health related Quality of Life will be measured using the EQ-5D-5L (Canadian version) [ Time Frame: 3 Months ]
- Frequency of health services utilization [ Time Frame: 3 Months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Persons aged over 18 years who are able to provide informed consent,
- Patient must have been assessed by a psychiatrist and fulfil the DSM-5 diagnostic criteria for Major Depressive Disorder or have completed the residential addiction treatment programme located at the Northern Addiction Treatment Centre and fulfil the DSM-5 diagnostic criteria for Alcohol Use Disorder.
- They must be familiar with or willing to learn how to receive text messages and will be available for follow-up.
- Patients who do not meet the above inclusion criteria
- Patients with Schizophrenia, Schizoaffective Disorder, Bipolar Disorder and other psychotic disorders. - -People who are living outside of regular cell phone connection areas
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327858
|Northern Lights Regional Health Centre|
|Fort McMurray, Alberta, Canada|
|Northern Addiction Rehabilitation Centre|
|Grande Prairie, Alberta, Canada|
|Principal Investigator:||Vincent IO Agyapong, MD FRCPC||Department of Psychiatry, University of Alberta|
|Study Director:||Serdar Dursun, PhD FRCPC||Department of Psychiatry, University of Alberta|
|Study Chair:||Andrew Greenshaw, PhD||Department of Psychiatry, University of Alberta|
|Responsible Party:||Vincent Agyapong, Clinical Associate Professor, University of Alberta|
|Other Study ID Numbers:||
|First Posted:||December 30, 2014 Key Record Dates|
|Last Update Posted:||August 8, 2016|
|Last Verified:||August 2016|