3M Study - Maria Malmö Mobile Telephone Study
This study is currently recruiting participants.
Verified October 2012 by Region Skane
Sponsor:
Region Skane
Information provided by (Responsible Party):
Anders C Håkansson, Region Skane
ClinicalTrials.gov Identifier:
NCT01706380
First received: October 8, 2012
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
The present study, in an out-patient setting for substance use treatment in adolescents, examines the effect on treatment retention of a mobile telephone follow-up technique (interactive voice response), with or without personal feedback. Subjects in treatment for substance use disorders will be followed by automated mobile telephone contact with questions about psychiatric symptoms and substance use, and the investigators hypothesize that this technique, including a personal feedback reporting back to the client whether his or her status is changing in one way or another, may increase the treatment retention, possibly by means of an intensified treatment contact.
| Condition | Intervention |
|---|---|
|
Substance Use Disorders |
Behavioral: Interactive voice response with personal feedback Behavioral: Interactive voice response without personal feedback |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders |
Further study details as provided by Region Skane:
Primary Outcome Measures:
- Retention in substance use disorder treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]Duration of retention in treatment and whether the client remains in treatment at 3 months or not.
Secondary Outcome Measures:
- Improvement in substance use [ Time Frame: 3 months ] [ Designated as safety issue: No ]Do patients in the intervention group improve more than in the control group, with respect to substance use (alcohol/drug use), during the duration of the interactive voice response intervention?
- Improvements in psychiatric symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]Do patients in the intervention group improve more than in the control group, with respect to psychiatric symptoms, during the duration of the interactive voice response intervention?
Other Outcome Measures:
- Clinical course with respect to emergency visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Clinical course with respect to hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Clinical course with respect to repeated treatment episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Interactive voice response with personal feedback
Interactive voice response follows the client twice weekly for 3 months with respect to symptoms and substance use, in both arms. This intervention group also receives a personalized and automated feedback describing whether the symptom status of the patient is better, worse or equal, compared to the preceding follow-up.
|
Behavioral: Interactive voice response with personal feedback
Personal feedback is given at the end of each automated telephone follow-up call, and reports back to the patient whether his och her symptom status is better, worse or equal, compared to the previous telephone call.
|
|
Active Comparator: Interactive voice response without personal feedback
This control group is also followed with identical interactive voice response follow-up, addressing symptoms and substance use, but without the personal feedback.
|
Behavioral: Interactive voice response without personal feedback
Control condition. Identical follow-up but without personal feedback.
|
Eligibility| Ages Eligible for Study: | up to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient applying for substance use disorder treatment at out-patient facility Maria Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706380
Locations
| Sweden | |
| Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden | Recruiting |
| Malmö, Skane, Sweden, 205 02 | |
| Contact: Anders Hakansson, MD, PhD + 46 703 135677 anders_c.hakansson@med.lu.se | |
| Contact: Martin Olsson, MD, PhD student + 46 46 171000 martin.o.olsson@skane.se | |
| Principal Investigator: Anders Hakansson, MD, PhD | |
Sponsors and Collaborators
Region Skane
More Information
No publications provided
| Responsible Party: | Anders C Håkansson, MD, PhD, Region Skane |
| ClinicalTrials.gov Identifier: | NCT01706380 History of Changes |
| Other Study ID Numbers: | 3M Study |
| Study First Received: | October 8, 2012 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Sweden: Ethics Committee, Lund University, Sweden Sweden: Dept of Psychiatry Skane, Sweden |
Keywords provided by Region Skane:
|
Substance use disorders Adolescents Retention |
Mobile telephone Follow-up Interactive voice response |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013