Mental DisordersNCT02529358
Text Message Based Maintenance Intervention
A study testing standardized text messages, Personalized text messages and Standardized text messages after 10 weeks in people with Mental Disorders, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
Trial summary
The study presents findings from a randomized clinical trial evaluating the effects of text messages encouraging short emotion regulation exercises on the course of psychopathological symptoms after inpatient treatment for depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- standardized text messages, Personalized text messages and Standardized text messages after 10 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good knowledge of the german language
- owning a mobile phone
Who cannot join
- brain damage
- personality disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Transdiagnostic Text Message Based Maintenance Intervention After Inpatient Cognitive Behavioural Therapy
The study presents findings from a randomized clinical trial evaluating the effects of text messages encouraging short emotion regulation exercises on the course of psychopathological symptoms after inpatient treatment for depression. In this context, the study also compares the effectiveness of standardized versus personalized text messages.
Read the detailed description
Introduction: The importance of aftercare and maintenance intervention to reduce psychopathology, prevent relapses and stabilize the effects of inpatient cognitive behavioral therapy is well proven. In order to attain a high reachability rate among the patients, simple, quick and low cost methods should be used. Modern communication technologies, such as mobile phones provide this opportunity. Therefore, the current study explores how modern communication technologies can be used as a support system in psychotherapy to realize a reduced psychopathology.
Methods: A total of 150 patients participated in a transdiagnostical 6-weeks text messaging maintenance intervention. The text messages were based on emotion regulation skills. The effectiveness of different variants of the text messages was studied in a randomized controlled trial, comparing the impact on the patient's psychopathological outcome to receiving personalized text messages versus standardized text messages.
- Conditions
- Mental Disorders
- Being tested
- standardized text messages, Personalized text messages, Standardized text messages after 10 weeks
- Keywords
- Maintenance intervention, Text messages, Emotion Regulation
- Medical subject headings
- Mental Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized text messagesBehavioural
Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies
Personalized text messagesBehavioural
Patients write their own messages
Standardized text messages after 10 weeksBehavioural
Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies which are send to the patients 10 weeks after completing inpatient therapy
| Study group | Role | What they receive |
|---|---|---|
| EG stand | Experimental | Standardized text messages Receives: Behavioral: standardized text messages |
| EG ind | Experimental | Personalized text messages Receives: Behavioral: Personalized text messages |
| Control | Other | Standardized text messages after 10 weeks Receives: Behavioral: Standardized text messages after 10 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom load
Measurement of depressive symptom severity with Beck Depression Inventory
Measured: 6 weeks post treatment (after intervention)
Emotion Regulation Competence
Emotion Regulation Competence measured by SERSA
Measured: 6 weeks post treatment (after intervention)
Secondary outcomes (3)
Psychopathological symptomatology
Measurement of psychopathological symptomatology with self report questionnaires
Measured: 10 weeks Follow-Up
Depressive Symptom load
Measurement of depressive symptom severity with Beck Depression Inventory
Measured: 10 weeks Follow-Up
Emotion Regulation Competence
Emotion Regulation Competence measured by SERSA
Measured: 10 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg
- Responsible party
- Principal investigator, Dipl.-Psych. Sandra Schlicker, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Sandra Schlicker, Dipl.-Psych., Principal investigator, Friedrich-Alexander-Universität Erlangen-NürnbergMatthias Berking, Prof. Dr., Study chair, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529358
- Sponsor's protocol ID
- SMS-MI
- Status last verified
- Aug 2015
- First submitted
- 18 Mar 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Transdiagnostic Text Message Based Maintenance Intervention After Inpatient Cognitive Behavioural Therapy
- ClinicalTrials.gov ID
- NCT02529358
- Acronym / sponsor ID
- SMS-MI
- Conditions
- Mental Disorders
- Keywords
- Maintenance intervention, Text messages, Emotion Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Philipps University Marburg
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study presents findings from a randomized clinical trial evaluating the effects of text messages encouraging short emotion regulation exercises on the course of psychopathological symptoms after inpatient treatment for depression. In this context, the study also compares the effectiveness of standardized versus personalized text messages.
Detailed description
Introduction: The importance of aftercare and maintenance intervention to reduce psychopathology, prevent relapses and stabilize the effects of inpatient cognitive behavioral therapy is well proven. In order to attain a high reachability rate among the patients, simple, quick and low cost methods should be used. Modern communication technologies, such as mobile phones provide this opportunity. Therefore, the current study explores how modern communication technologies can be used as a support system in psychotherapy to realize a reduced psychopathology.
Methods: A total of 150 patients participated in a transdiagnostical 6-weeks text messaging maintenance intervention. The text messages were based on emotion regulation skills. The effectiveness of different variants of the text messages was studied in a randomized controlled trial, comparing the impact on the patient's psychopathological outcome to receiving personalized text messages versus standardized text messages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EG stand | Experimental | Behavioral: standardized text messagesStandardized text messages |
| EG ind | Experimental | Behavioral: Personalized text messagesPersonalized text messages |
| Control | Other | Behavioral: Standardized text messages after 10 weeksStandardized text messages after 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- good knowledge of the german language
- owning a mobile phone
Key exclusion criteria (2 listed)
- brain damage
- personality disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized text messagesMessages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies | Behavioural | EG stand |
| Personalized text messagesPatients write their own messages | Behavioural | EG ind |
| Standardized text messages after 10 weeksMessages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies which are send to the patients 10 weeks after completing inpatient therapy | Behavioural | Control |
Primary outcome
Depressive Symptom load
Time frame: 6 weeks post treatment (after intervention)
Measurement of depressive symptom severity with Beck Depression Inventory
Emotion Regulation Competence
Time frame: 6 weeks post treatment (after intervention)
Emotion Regulation Competence measured by SERSA
3 secondary outcomes
Psychopathological symptomatology
Time frame: 10 weeks Follow-Up
Depressive Symptom load
Time frame: 10 weeks Follow-Up
Emotion Regulation Competence
Time frame: 10 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Schlicker, Dipl.-Psych. principal investigator
Friedrich-Alexander-Universität Erlangen-Nürnberg
Matthias Berking, Prof. Dr. study chair
Friedrich-Alexander-Universität Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized text messages, Personalized text messages and Standardized text messages after 10 weeks in people with Mental Disorders, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptom load (time frame: 6 weeks post treatment (after intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.