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Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

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ClinicalTrials.gov Identifier: NCT03979963
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Verena Zimmermann, Heidelberg University

Brief Summary:
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.

Condition or disease
Depression

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Depressive Symptoms and Emotion Regulation Following Outpatient Cognitive Behavioral Therapy for Depression: a Longitudinal Study
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in ecological momentary assessment scores [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in ecological momentary assessment scores. Data will be collected using the smartphone app EmoTrack2. The app measures emotions experienced, context factors of the emotional experiences, and emotions regulation strategies used (five measurements per day over a period of seven consecutive days).

  2. Change in the mental disorders diagnosed with the Structured Clinical Interview for DSM-5 (SCID-5) [ Time Frame: 0, 6, 12, and 24 months after completion of cognitive behavioral therapy ]
    Change in the mental disorders diagnosed with the German version of the Structured Clinical Interview for DSM-5

  3. Change in the score on the Beck Depression Inventory-II (BDI-II) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the score on the German version of the Beck Depression Inventory-II

  4. Change in the score on the WHO (Five) Well-Being Index (WHO-5) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the score on the German version of the WHO (Five) Well-Being Index

  5. Change in the scores on the Brief-Symptom-Checklist (BSCL) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the German short form of the Symptom Checklist-90-Revised

  6. Change in the scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the German version of the Center for Epidemiologic Studies Depression Scale

  7. Change in the scores on the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the German version of the Difficulties in Emotion Regulation Scale

  8. Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (HFERST) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (German questionnaire)


Secondary Outcome Measures :
  1. Change in the scores on the Questions on Life Satisfaction (FLZM) [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the Questions on Life Satisfaction (German Questionnaire)

  2. Change in the scores on the Revised UCLA Loneliness Scale [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the German version of the Revised UCLA Loneliness Scale

  3. Change in the scores on the Rosenberg's Self-Esteem Scale [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy ]
    Change in the scores on the revised version of the German adaptation of Rosenberg's Self-Esteem Scale



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who have recently completed outpatient cognitive behavioral therapy for depression
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979963


Contacts
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Contact: Verena Zimmermann, M.Sc. +49 6221 547295 verena.zimmermann@psychologie.uni-heidelberg.de
Contact: Christina Timm, M.Sc. +49 6221 547715 christina.timm@psychologie.uni-heidelberg.de

Locations
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Germany
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University Recruiting
Heidelberg, Germany, 69117
Contact: Verena Zimmermann, M.Sc.    +49 6221 547295    verena.zimmermann@psychologie.uni-heidelberg.de   
Contact: Christina Timm, M.Sc.    +49 6221 547715    christina.timm@psychologie.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Verena Zimmermann, M.Sc. Department of Clinical Psychology and Psychotherapy, Heidelberg University
Principal Investigator: Christina Timm, M.Sc. Department of Clinical Psychology and Psychotherapy, Heidelberg University
Principal Investigator: Annemarie Miano, PhD Department of Clinical Psychology and Psychotherapy, Heidelberg University
Principal Investigator: Sven Barnow, Prof. Department of Clinical Psychology and Psychotherapy, Heidelberg University

Publications:
Beck AT, Steer RA, Brown GK. Beck depression inventory - second edition. Manual. San Antonio, TX: Psychological Corporation, 1996.
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.
Derogatis, LR. SCL-90-R: Administration, scoring, and procedures manual. Baltimore: Clinical Psychometric Research, 1977.
Döring N, Bortz J. Psychometrische Einsamkeitsforschung: deutsche Neukonstruktion der UCLA Loneliness Scale. Diagnostica 39(3): 224-239, 1993.
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.
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.
Franke GH. BSCL. Brief-Symptom-Checklist. Göttingen: Hogrefe Verlag, 2012.
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.
Hautzinger M, Bailer M, Hofmeister D, Keller F. Allgemeine Depressionsskala. 2., überarbeitete und neu normierte Auflage. Göttingen: Hogrefe Verlag, 2012.
Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar - Manual. Frankfurt am Main: Harcourt Test Services, 2006.
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.
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.
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.
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.
Rosenberg M. Sosciety and the adolescent self-image. Princeton, NJ: Princeton University Press, 1965.
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.

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Responsible Party: Verena Zimmermann, Research Associate, Heidelberg University
ClinicalTrials.gov Identifier: NCT03979963     History of Changes
Other Study ID Numbers: Depression & ER
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verena Zimmermann, Heidelberg University:
Depression
Emotion Regulation
Cognitive Behavioral Therapy
Ecological Momentary Assessment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders