An SMS-assisted mindfulness-based intervention for relapse prevention in depression
| ISRCTN | ISRCTN58808893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58808893 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/04/2014
- Registration date
- 06/06/2014
- Last edited
- 04/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Section Process-Outcome Research
Department of Psychiatry and Psychotherapy II
Ulm University
Bezirkskrankenhaus Guenzburg
Ludwig-Heilmeyer-Str. 2
Guenzburg
89312
Germany
Study information
| Study design | Pilot study prospective single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An SMS-assisted mindfulness-based intervention for relapse prevention in depression: a pilot randomized controlled trial |
| Study acronym | MIND-S |
| Study objectives | 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(s) | Ulm University Ethics Committee; 13/08/2013; ref. 231/13 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 24/09/2013 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Age: 18 to 75 years 2. Symptoms of depression during the current illness episode 3. Mobile phone |
| Key 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 |
| Date of first enrolment | 24/09/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
89312
Germany
Sponsor information
Government
Ministerium fuer Wissenschaft, Forschung und Kunst Baden-Wuerttemberg
Koenigstr. 46
Stuttgart
70173
Germany
"ROR" |
https://ror.org/01hc18p32 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/05/2017 | Yes | No |
Editorial Notes
04/05/2017: Publication reference added.
