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Trial record 2 of 5 for:    agyapong

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
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Vincent Agyapong, University of Alberta

Brief Summary:
According to the World Health Organisation, depression and problem drinking are among the leading causes of disability worldwide. Most patients who present with problem drinking and/or depression have poor quality of life and pose a great economic burden to society due to their higher use of health services. We seek to develop a new, enhanced, efficient, innovative and cost effective treatment strategy aimed at reducing the burden that these two mental conditions impose on sufferers, their families as well as the community and health systems. In a recent pilot study of supportive text messages in Ireland conducted by the Principal Applicant and a team of researchers for patients with problem drinking and co-occurring depression, we established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.Our study was limited by the small number of participants and it did not examine the impact of the text messages on health services utilization. Our study did not also examine the effects of supportive text messages on those with only depression or only problem drinking. The proposed study seeks to extend the knowledge gained from the pilot study in Ireland by examining the impact of supportive text messages in the individual disorders

Condition or disease Intervention/treatment Phase
Depression Alcoholism Other: Supportive text messages Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Mean changes in the BDI scores from baseline for those with a primary diagnosis of Depression [ Time Frame: 3 Months ]
  2. Cumulative Abstinence Duration from baseline (Since discharge from the Residential Addiction treatment programme) for those with AUD. [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Mean units of alcohol per drinking days for participants with AUD [ Time Frame: 3 Months ]
  2. Mean Days to first drink for participants with AUD [ Time Frame: 3 Months ]
  3. Number of hazardous drinking days from baseline for participants with AUD [ Time Frame: 3 Months ]
  4. Health related Quality of Life will be measured using the EQ-5D-5L (Canadian version) [ Time Frame: 3 Months ]

Other Outcome Measures:
  1. 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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Canada, Alberta
Northern Lights Regional Health Centre
Fort McMurray, Alberta, Canada
Northern Addiction Rehabilitation Centre
Grande Prairie, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Alberta Health Services
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vincent Agyapong, Clinical Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02327858     History of Changes
Other Study ID Numbers: Pro00054068
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Alcoholism
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders