Submission date
10/07/2017
Registration date
12/07/2017
Last edited
04/08/2021
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Mental and Behavioural Disorders
Prospectively registered
? Protocol not yet added
? SAP not yet added
Results not expected as study has stopped
Raw data not expected as study has stopped
Study stopped

Plain English Summary

Background and study aims
Text-messaging-based aftercare has been shown to be effective for various mental health problems such as eating disorders and alcohol withdrawal. Former patients can generally be reached easily with text messages, which might help to reduce their risk of relapsing. The aim of this study is to assess the effectiveness of text messages in helping former patients (previously treated in addiction centers) to maintain their substance use goal during the 6 months following inpatient treatment.

Who can participate?
Patients aged 18 and over who have completed their addiction treatment

What does the study involve ?
Participants are randomly allocated to one of two groups shortly before leaving the treatment center. Participants in one group receive automatically generated supportive text-messages to help them to avoid relapses. Participants in the other group receive semi-automatically generated, individualised supportive text messages and also telephone calls from a counselor. Text messages are sent for a period of six months after patients have left treatment, first weekly, then biweekly. Both groups are assessed for their maintenance of abstinence or controlled drinking (depending on personal goals) during the 6 months following inpatient treatment.

What are the possible benefits and risks of participating ?
Former patients who receive text message based aftercare might be encouraged to avoid relapses. No risks are expected.

Where is the study run from?
1. Swiss Research Institute for Public Health and Addiction ISGF (Switzerland)
2. Akzente Prävention und Suchttherapie, Luzern (Switzerland)
3. Die Alternative, Ottenbach (Switzerland)
4. Freihof Küsnacht, Küsnacht (Switzerland)
5. Forelhaus, Zürich (Switzerland)
6. RehabilitationsZentrum Lutzenberg, Lutzenberg (Switzerland)
7. Suchttherapiebärn, Bern (Switzerland)

When is the study starting and how long is it expected to run for?
September 2015 to July 2020

Who is funding the study?
Federal Office of Public Health (FOPH) (Switzerland)

Who is main contact ?
Mrs Susanne Schaaf
schaaf@isgf.uzh.ch

Study website

Contact information

Type

Scientific

Contact name

Mrs Susanne Schaaf

ORCID ID

http://orcid.org/0000-0003-3763-9863

Contact details

Swiss Research Institute for Public Health and Addiction ISGF
Konradstrasse 32
PO Box
Zurich
8031
Switzerland
+41 (0)44 448 11 60
schaaf@isgf.uzh.ch

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

PEG201410

Study information

Scientific title

Efficacy of text messaging-based aftercare following inpatient addiction treatment - DASA (Drug Alcohol SMS Aftercare): a randomised controlled trial

Acronym

DASA – Drug Alcohol SMS Aftercare

Study hypothesis

Individualised SMS-based intervention (including information on personal reward suggestions and coping strategies on how to deal with tempting situations, as well as in addition phone calls from therapists) is more effective than non-individualised SMS-based intervention to maintain abstinence or controlled drinking (depending on the personally set goal).

Ethics approval(s)

Ethics Committee Zurich (lead committee), 19/06/2017, ref: PB_2016_02180

Study design

Multicentre randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Prevention

Patient information sheet

See additional files

Condition

Relapse prevention for former patients who completed addiction treatment successfully

Intervention

Randomisation will be undertaken centrally by the Swiss Reasearch Institute for Public Health an Addiction ISGF. The questionnaires will be handed out to the participating treatment centers, and will be stratified by gender and main problem substance of patients, resulting in four combinations: a) female, alcohol, b) male, alcohol, c) female, drug (not-prescribed opiates, cocaine or cannabis), c) male, drug (ditto). Within each combination, the questionnaires are - according to the randomisation list - assigned to either control group or intervention group. The therapist fills in the questionnaire together with the client. The allocation to the study group will be disclosed on the last page of the questionnaire

The patients will be randomly assigned to one of two study groups shortly before leaving the treatment center:
1. Minimal/standardised intervention control group (CG): automatically generated, standardised text-messages, standardised supportive messages: first weekly, then biweekly SMS regarding maintenance of abstinence or controlled alcohol use respectively; support from advisor on demand
2. Intervention group (IG): semi-automatically generated, individualised text-messages: first weekly, then bi-weekly SMS regarding maintenance of abstinence resp. controlled alcohol use; individualised supportive text-messages reward, coping strategies) and active contacting by advisor in case of not-maintaining abstinence resp. controlled alcohol use.

SMS messages will be sent for a period of six months after patients have left treatment, first weekly, then biweekly.

The primary outcome measures are assessed at 6-months follow up. Frequency of use of the respective main problem substance within the previous six months will be assessed. Participants indicating that they never used the substance within the previous six months are considered as abstinent (prolonged abstinence). Concerning controlled drinking, the participants should indicate whether or not they always maintained their personal goal of alcohol use within the previous six months (prolonged maintenance of drinking goal).

Intervention type

Other

Primary outcome measure

Maintenance of abstinence (illegal substances such as opiates, cocaine, cannabis; legal substance: alcohol) or maintenance of controlled drinking (depending on personal goals) during the 6 months following inpatient treatment, assessed by self-report at 6-months follow up

Secondary outcome measures

1. Retention to intervention program (intervention group vs control group), assessed by measuring the proportion of participants which did not actively discontinue programme participation during the study period of 6 months by informing the study center via phone, text message or e-mail
2. 7-day and 30-day point prevalence abstinence and maintenance of controlled drinking, respectively, assessed by self-report at 6-months follow up
3. Acceptance of intervention program by former patients (intervention group vs control group), assessed using the log files of the text messaging system during the study period of 6 months

Overall study start date

07/09/2015

Overall study end date

31/07/2020

Reason abandoned (if study stopped)

Objectives no longer viable

Eligibility

Participant inclusion criteria

1. Age >=18 years
2. Residential treatment will presumably be finished within one week
3. Main problem substances at beginning of treatment: opioids, cocaine, cannabis or alcohol
4. Personally set goals: abstinence (re. illegal substances and alcohol) or controlled drinking respectively
5. Owning a mobile phone

Participant type(s)

Other

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

554

Participant exclusion criteria

Cognitive or linguistic deficits or health impairments which impede following the SMS dialogue

Recruitment start date

01/08/2017

Recruitment end date

15/06/2019

Locations

Countries of recruitment

Switzerland

Study participating centre

RehabilitationsZentrum Lutzenberg
Lutzenberg
9426
Switzerland

Study participating centre

Suchttherapiebärn
Bern
3006
Switzerland

Study participating centre

Akzent Prävention und Suchttherapie
Luzern
6003
Switzerland

Study participating centre

Die Alternative
Ottenbach
8913
Switzerland

Study participating centre

Freihof Küsnacht
Küsnacht
8700
Switzerland

Study participating centre

Forelhaus
Zürich
8003
Switzerland

Sponsor information

Organisation

Swiss Research Institute for Public Health and Addiction ISGF

Sponsor details

Konradstrasse 32
PO Box
Zurich
8031
Switzerland
+41 (0)44 448 11 60
schaaf@isgf.uzh.ch

Sponsor type

Research organisation

Website

www.isgf.ch

ROR

https://ror.org/02crff812

Funders

Funder type

Government

Funder name

Federal Office of Public Health (FOPH)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2021.

Intention to publish date

31/07/2021

Individual participant data (IPD) sharing plan

The datasets generated during and/or analysed during the current study are not expected to be made available due to a lack of participants' consent to share data with other institutions.

IPD sharing plan summary

Not expected to be made available

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 12/07/2017 12/07/2017 No Yes

Additional files

Editorial Notes

04/08/2021: The trial was stopped due to the requirements of the ethics committee.