Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

NCT ID: NCT03979963

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2021-12-31

Brief Summary

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This study investigates depressive symptoms and the use of emotion regulation strategies over the course of a two-year period in participants terminating outpatient cognitive behavioral therapy for depression. The main objective of the study is to examine if changes in the use of certain emotion regulation strategies (e.g. reappraisal, rumination) predict depression relapse or changes in depressive symptoms after the completion of outpatient cognitive behavioral therapy.

Detailed Description

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Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age older than 18 years
* regular termination of outpatient cognitive behavioral therapy for depression (or premature termination agreed upon by both the therapist and the patient because of symptom improvement after at least 12 sessions)
* last therapy session not more than two weeks prior to enrollment
* self-reported improvement in depressive symptoms as a result of cognitive behavioral therapy
* possession of a smartphone (operating system: Android or iOS) with Internet access
* possession of a laptop/desktop computer with Internet access
* familiarity with apps and the Internet
* fluency in German language

Exclusion Criteria

* premature termination of outpatient cognitive behavioral therapy (exception: termination agreed upon by both the therapist and the patient because of symptom improvement)
* BDI-II score ≥ 20
* acute substance use disorder (\< 3 months)
* current or past psychotic disorder
* current or past (hypo)manic episode
* acute suicidality
* severe neurological disorder/cerebral damage
* severe physical/medical illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Verena Zimmermann

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Verena Zimmermann, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychotherapy, Heidelberg University

Christina Timm, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychotherapy, Heidelberg University

Annemarie Miano, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychotherapy, Heidelberg University

Sven Barnow, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Psychology and Psychotherapy, Heidelberg University

Locations

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Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Verena Zimmermann, M.Sc.

Role: CONTACT

+49 6221 547295

Christina Timm, M.Sc.

Role: CONTACT

+49 6221 547715

Facility Contacts

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Verena Zimmermann, M.Sc.

Role: primary

+49 6221 547295

Christina Timm, M.Sc.

Role: backup

+49 6221 547715

References

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Beck AT, Steer RA, Brown GK. Beck depression inventory - second edition. Manual. San Antonio, TX: Psychological Corporation, 1996.

Reference Type BACKGROUND

Beesdo-Baum K, Zaudig M, Wittchen H-U. SCID-5-CV. Strukturiertes klinisches Interview für DSM-5®-Störungen - klinische Version. Deutsche Bearbeitung des structured clinical interview for DSM-5® disorders - clinician version von Michael B. First, Janet B.W. Williams, Rhonda S. Karg, Robert L. Spitzer. Göttingen: Hogrefe Verlag, 2019.

Reference Type BACKGROUND

Derogatis, LR. SCL-90-R: Administration, scoring, and procedures manual. Baltimore: Clinical Psychometric Research, 1977.

Reference Type BACKGROUND

Döring N, Bortz J. Psychometrische Einsamkeitsforschung: deutsche Neukonstruktion der UCLA Loneliness Scale. Diagnostica 39(3): 224-239, 1993.

Reference Type BACKGROUND

Ehring T. Übersetzung und Validierung dreier Instrumente zur Erfassung von Merkmalen der Emotionsregulation [Translation and validation of three instruments for the assessment of characteristics of emotion regulation. In preparation.

Reference Type BACKGROUND

First MB, Williams JBW, Karg RS, Spitzer RL. Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). Arlington, VA: American Psychiatric Association, 2016.

Reference Type BACKGROUND

Franke GH. BSCL. Brief-Symptom-Checklist. Göttingen: Hogrefe Verlag, 2012.

Reference Type BACKGROUND

Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment 26(1): 41-54, 2004.

Reference Type BACKGROUND

Hautzinger M, Bailer M, Hofmeister D, Keller F. Allgemeine Depressionsskala. 2., überarbeitete und neu normierte Auflage. Göttingen: Hogrefe Verlag, 2012.

Reference Type BACKGROUND

Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt am Main: Harcourt Test Services, 2006.

Reference Type BACKGROUND

Henrich G, Herschbach P. Questions on life satisfaction (FLZM) - a short questionnaire for assessing subjective quality of life. European Journal of Psychological Assessment 16(3), 150-159, 2000.

Reference Type BACKGROUND

Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.

Reference Type BACKGROUND
PMID: 28730850 (View on PubMed)

Psychiatric Research Unit, WHO Collaborating Center for Mental Health. WHO (five) well-being index (1998 version). Retrieved from: https://www.psykiatri-regionh.dk/who-5/Documents/WHO5_English.pdf, 1998.

Reference Type BACKGROUND

Psychiatric Research Unit, WHO Collaborating Center for Mental Health. WHO (fünf) - Fragebogen zum Wohlbefinden (Version 1998). Retrieved from: https://www.psykiatri-regionh.dk/who-5/Documents/WHO5_German.pdf, 1998.

Reference Type BACKGROUND

Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 3(1): 385-401, 1977.

Reference Type BACKGROUND

Rosenberg M. Sosciety and the adolescent self-image. Princeton, NJ: Princeton University Press, 1965.

Reference Type BACKGROUND

Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.

Reference Type BACKGROUND
PMID: 7431205 (View on PubMed)

von Collani G, Herzberg PY. Eine revidierte Fassung der deutschsprachigen Skala zum Selbstwertgefühl von Rosenberg. Zeitschrift für Differentielle und Diagnostische Psychologie 24(1): 3-7, 2003.

Reference Type BACKGROUND

Other Identifiers

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Depression & ER

Identifier Type: -

Identifier Source: org_study_id

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