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, at discharge from hospital and four-months follow-up.
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
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 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 measure
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 (if study stopped)
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
Ulm University
Guenzburg
89312
Germany
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28465278