Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy
26. april 2021 oppdatert av: Verena Zimmermann, Heidelberg University
Depressive Symptoms and Emotion Regulation Following Outpatient Cognitive Behavioral Therapy for Depression: a Longitudinal Study
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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Observasjonsmessig
Registrering (Forventet)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Verena Zimmermann, M.Sc.
- Telefonnummer: +49 6221 547295
- E-post: verena.zimmermann@psychologie.uni-heidelberg.de
Studer Kontakt Backup
- Navn: Christina Timm, M.Sc.
- Telefonnummer: +49 6221 547715
- E-post: christina.timm@psychologie.uni-heidelberg.de
Studiesteder
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-
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Heidelberg, Tyskland, 69117
- Rekruttering
- Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University
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Ta kontakt med:
- Verena Zimmermann, M.Sc.
- Telefonnummer: +49 6221 547295
- E-post: verena.zimmermann@psychologie.uni-heidelberg.de
-
Ta kontakt med:
- Christina Timm, M.Sc.
- Telefonnummer: +49 6221 547715
- E-post: christina.timm@psychologie.uni-heidelberg.de
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Individuals who have recently completed outpatient cognitive behavioral therapy for depression
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in ecological momentary assessment scores
Tidsramme: 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).
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the mental disorders diagnosed with the Structured Clinical Interview for DSM-5 (SCID-5)
Tidsramme: 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
|
0, 6, 12, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the score on the Beck Depression Inventory-II (BDI-II)
Tidsramme: 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
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the score on the WHO (Five) Well-Being Index (WHO-5)
Tidsramme: 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
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the scores on the Brief-Symptom-Checklist (BSCL)
Tidsramme: 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
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
|
Change in the scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsramme: 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
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
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Change in the scores on the Difficulties in Emotion Regulation Scale (DERS)
Tidsramme: 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
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
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Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (HFERST)
Tidsramme: 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)
|
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the scores on the Questions on Life Satisfaction (FLZM)
Tidsramme: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the Questions on Life Satisfaction (German Questionnaire)
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
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Change in the scores on the Revised UCLA Loneliness Scale
Tidsramme: 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
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
|
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Change in the scores on the Rosenberg's Self-Esteem Scale
Tidsramme: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Change in the scores on the revised version of the German adaptation of Rosenberg's Self-Esteem Scale
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0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Verena Zimmermann, M.Sc., Department of Clinical Psychology and Psychotherapy, Heidelberg University
- Hovedetterforsker: Christina Timm, M.Sc., Department of Clinical Psychology and Psychotherapy, Heidelberg University
- Hovedetterforsker: Annemarie Miano, PhD, Department of Clinical Psychology and Psychotherapy, Heidelberg University
- Hovedetterforsker: Sven Barnow, Prof., Department of Clinical Psychology and Psychotherapy, Heidelberg University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. juni 2019
Primær fullføring (Forventet)
1. desember 2021
Studiet fullført (Forventet)
1. desember 2021
Datoer for studieregistrering
Først innsendt
27. mai 2019
Først innsendt som oppfylte QC-kriteriene
6. juni 2019
Først lagt ut (Faktiske)
10. juni 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Depression & ER
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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