NCT02529358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

March 18, 2015

Last Update Submit

August 19, 2015

Conditions

Mental Disorders

Keywords

Maintenance interventionText messagesEmotion Regulation

Outcome Measures

Primary Outcomes (2)

  • Depressive Symptom load

    Measurement of depressive symptom severity with Beck Depression Inventory

    6 weeks post treatment (after intervention)

  • Emotion Regulation Competence

    Emotion Regulation Competence measured by SERSA

    6 weeks post treatment (after intervention)

Secondary Outcomes (3)

  • Psychopathological symptomatology

    10 weeks Follow-Up

  • Depressive Symptom load

    10 weeks Follow-Up

  • Emotion Regulation Competence

    10 weeks follow up

Study Arms (3)

EG stand

EXPERIMENTAL

Standardized text messages

Behavioral: standardized text messages

EG ind

EXPERIMENTAL

Personalized text messages

Behavioral: Personalized text messages

Control

OTHER

Standardized text messages after 10 weeks

Behavioral: Standardized text messages after 10 weeks

Interventions

standardized text messagesBEHAVIORAL

Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies

EG stand
Personalized text messagesBEHAVIORAL

Patients write their own messages

EG ind
Standardized text messages after 10 weeksBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good knowledge of the german language
  • owning a mobile phone

You may not qualify if:

  • brain damage
  • personality disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik

Bad Arolsen, Hesse, 34454, Germany

Location

MeSH Terms

Conditions

Mental DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Sandra Schlicker, Dipl.-Psych.

    Friedrich-Alexander-Universität Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR

  • Matthias Berking, Prof. Dr.

    Friedrich-Alexander-Universität Erlangen-Nürnberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipl.-Psych.

Study Record Dates

First Submitted

March 18, 2015

First Posted

August 20, 2015

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

DE(1)