Condition category
Mental and Behavioural Disorders
Date applied
10/04/2014
Date assigned
06/06/2014
Last edited
06/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Mindfulness-based interventions aim at promoting an intentional, non-judgemental attention to the present moment and have been shown to be helpful in preventing the reoccurrence of depression. Mobile communication technologies (such as short message service, SMS) can be used to maintain treatment gains and achieve long-term behaviour changes. Mindfulness-based interventions have rarely been studied in inpatient settings. Therefore, we have developed a low intensity program for psychiatric inpatients with depression which combines mindfulness exercises with SMS-assistance. The aim of this pilot study is to inform the planning of a full-scale trial and examine whether the study design is feasible, i.e. how many patients are willing to participate in the study, fill in the questionnaires, use the SMS-assistance and are satisfied with the intervention. Furthermore, we will examine the usability of the questionnaires.

Who can participate?
Adult inpatients of the Clinic of Psychiatry and Psychotherapy II (Guenzburg), Ulm University, with symptoms of depression. Participants should have a mobile phone and sufficient knowledge of the German language.

What does the study involve?
The intervention consists of two steps. First, in addition to standard inpatient care, participants will be invited to attend a group introduction to three mindfulness exercises during their hospital stay. Second, after discharge from hospital, participants will be randomly allocated to either receive the SMS-assistance or recieve no additional support. Over a period of four months after discharge, participants will be asked to report via SMS whenever they have practiced a mindfulness exercise, and in return receive reinforcing feedback. Assessment points are at study intake (t0), at discharge from hospital (t1) and four-months follow-up (t2).

What are the possible benefits and risks of participating?
Research indicates that mindfulness interventions can be helpful in preventing the reoccurrence of depression. SMS-interventions have been shown to support long term behaviour changes. Thus, possible benefits are a decreased risk of depressive relapse and an improvement of general well-being. Overall, negative outcomes are rarely reported. The mindfulness exercises are introduced during the inpatient stay of the patient. Therefore, any adverse reactions can immediately be responded to.

Where is the study run from?
Enrolment takes place at the Clinic for Psychiatry and Psychotherapy in Guenzburg (lead centre MIND-S-study). Technical and methodological support is provided by the Center of Psychotherapy Research, University of Heidelberg.

When is the study starting and how long is it expected to run for?
The study started in September 2013. Data acquisition will last approximately until the end of 2014

Who is funding the study?
"Innovationsfonds Medizin", a research fund provided by the Ministry of Science, Research and Art of the State of Baden-Wuerttemberg, Germany.

Who is the main contact?
Dr. Bernd Puschner
bernd.puschner@bkh-guenzburg.de

Trial website

http://www.uni-ulm.de/psychiatrieII/en_projects/mind_s.htm

Contact information

Type

Scientific

Primary contact

Dr Bernd Puschner

ORCID ID

Contact details

Section Process-Outcome Research
Department of Psychiatry and Psychotherapy II
Ulm University
Bezirkskrankenhaus Guenzburg
Ludwig-Heilmeyer-Str. 2
Guenzburg
89312
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An SMS-assisted mindfulness-based intervention for relapse prevention in depression: a pilot randomized controlled trial

Acronym

MIND-S

Study hypothesis

The study examines the feasibility of the study design and the intervention. Research questions are:
1. Feasibility of the study design in terms of recruitment, randomisation, retention, and usability of the measures.
2. Feasibility of the intervention in terms of adherence and acceptability

Ethics approval

Ulm University Ethics Committee; 13/08/2013; ref. 231/13

Study design

Pilot study prospective single center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depressive symptoms, relapse prevention

Intervention

1. During inpatient psychiatric treatment: Manualized group session introducing three mindfulness-based exercises (mindful breathing, mindful walking, mindfulness of the body). Study participants should attend the group at least once.
2. After discharge (t1) for participants allocated to intervention group: Assistance of mindfulness practice at home, using positive reinforcement via the mobile phone SMS-technology and weekly reminders (until 4-month follow-up, t2)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility and acceptability of the study design and procedures:
1. Number of patients recruited (at study intake, t0) and randomized (at hospital discharge, t1), drop-out rates until follow up (four months after discharge, t2)
2. Homework compliance (questionnaire at t2)
3. Use of the SMS-assistance during the four months after hospital discharge (objective measure)
4. Satisfaction with the interventions (questionnaires at timepoints: t1, t2)

Secondary outcome measures

Usability of the selected questionnaires (measuring homework compliance, depressive symptoms etc.), assessed at all measurement-points (t0-t2)

Overall trial start date

24/09/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: 18 to 75 years
2. Symptoms of depression during the current illness episode
3. Mobile phone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Psychotic symptoms, or a history of schizophrenia
2. Current manic state
3. Acute risk of a dissociative crisis
4. Severe cognitive deficit/impairment
5. Persistent severe substance abuse
6. Acute risk of suicidality or self-harm
7. Insufficient command of the German language

Recruitment start date

24/09/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Section Process-Outcome Research
Guenzburg
89312
Germany

Sponsor information

Organisation

The Ministry of Science, Research and Art of the State of Baden-Wuerttemberg (Germany)

Sponsor details

Ministerium fuer Wissenschaft
Forschung und Kunst Baden-Wuerttemberg
Koenigstr. 46
Stuttgart
70173
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Ministry of Science, Research and Art of the State of Baden-Wuerttemberg (Germany) - Innovationsfonds Medizin - Kompetenzzentrum Praevention psychischer und psychosomatischer Stoerungen in der Arbeits- und Ausbildungswelt (PPAA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes