Text Message Based Maintenance Intervention
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
standardized text messages
Personalized text messages
Standardized text messages after 10 weeks
Sponsored by
About this trial
This is an interventional prevention trial for Mental Disorders focused on measuring Maintenance intervention, Text messages, Emotion Regulation
Eligibility Criteria
Inclusion Criteria:
- good knowledge of the german language
- owning a mobile phone
Exclusion Criteria:
- brain damage
- personality disorders
Sites / Locations
- Schön Klinik
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
EG stand
EG ind
Control
Arm Description
Standardized text messages
Personalized text messages
Standardized text messages after 10 weeks
Outcomes
Primary Outcome Measures
Depressive Symptom load
Measurement of depressive symptom severity with Beck Depression Inventory
Emotion Regulation Competence
Emotion Regulation Competence measured by SERSA
Secondary Outcome Measures
Psychopathological symptomatology
Measurement of psychopathological symptomatology with self report questionnaires
Depressive Symptom load
Measurement of depressive symptom severity with Beck Depression Inventory
Emotion Regulation Competence
Emotion Regulation Competence measured by SERSA
Full Information
NCT ID
NCT02529358
First Posted
March 18, 2015
Last Updated
August 19, 2015
Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Collaborators
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02529358
Brief Title
Text Message Based Maintenance Intervention
Official Title
Evaluation of a Transdiagnostic Text Message Based Maintenance Intervention After Inpatient Cognitive Behavioural Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Collaborators
Philipps University Marburg Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Maintenance intervention, Text messages, Emotion Regulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EG stand
Arm Type
Experimental
Arm Description
Standardized text messages
Arm Title
EG ind
Arm Type
Experimental
Arm Description
Personalized text messages
Arm Title
Control
Arm Type
Other
Arm Description
Standardized text messages after 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
standardized text messages
Intervention Description
Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies
Intervention Type
Behavioral
Intervention Name(s)
Personalized text messages
Intervention Description
Patients write their own messages
Intervention Type
Behavioral
Intervention Name(s)
Standardized text messages after 10 weeks
Intervention Description
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
Primary Outcome Measure Information:
Title
Depressive Symptom load
Description
Measurement of depressive symptom severity with Beck Depression Inventory
Time Frame
6 weeks post treatment (after intervention)
Title
Emotion Regulation Competence
Description
Emotion Regulation Competence measured by SERSA
Time Frame
6 weeks post treatment (after intervention)
Secondary Outcome Measure Information:
Title
Psychopathological symptomatology
Description
Measurement of psychopathological symptomatology with self report questionnaires
Time Frame
10 weeks Follow-Up
Title
Depressive Symptom load
Description
Measurement of depressive symptom severity with Beck Depression Inventory
Time Frame
10 weeks Follow-Up
Title
Emotion Regulation Competence
Description
Emotion Regulation Competence measured by SERSA
Time Frame
10 weeks follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
good knowledge of the german language
owning a mobile phone
Exclusion Criteria:
brain damage
personality disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Schlicker, Dipl.-Psych.
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthias Berking, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Official's Role
Study Chair
Facility Information:
Facility Name
Schön Klinik
City
Bad Arolsen
State/Province
Hessen
ZIP/Postal Code
34454
Country
Germany
12. IPD Sharing Statement
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Text Message Based Maintenance Intervention
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