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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02529358
Other study ID # SMS-MI
Secondary ID
Status Completed
Phase N/A
First received March 18, 2015
Last updated August 19, 2015
Start date February 2012
Est. completion date October 2013

Study information

Verified date August 2015
Source Friedrich-Alexander-Universität Erlange-Nürnberg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical 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. In this context, the study also compares the effectiveness of standardized versus personalized text messages.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- good knowledge of the german language

- owning a mobile phone

Exclusion Criteria:

- brain damage

- personality disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
standardized text messages
Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies
Personalized text messages
Patients write their own messages
Standardized text messages after 10 weeks
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

Locations

Country Name City State
Germany Schön Klinik Bad Arolsen Hessen

Sponsors (2)

Lead Sponsor Collaborator
Friedrich-Alexander-Universität Erlange-Nürnberg Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive Symptom load Measurement of depressive symptom severity with Beck Depression Inventory 6 weeks post treatment (after intervention) No
Primary Emotion Regulation Competence Emotion Regulation Competence measured by SERSA 6 weeks post treatment (after intervention) No
Secondary Psychopathological symptomatology Measurement of psychopathological symptomatology with self report questionnaires 10 weeks Follow-Up No
Secondary Depressive Symptom load Measurement of depressive symptom severity with Beck Depression Inventory 10 weeks Follow-Up No
Secondary Emotion Regulation Competence Emotion Regulation Competence measured by SERSA 10 weeks follow up No
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