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Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

26 april 2021 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Förväntat)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Individuals who have recently completed outpatient cognitive behavioral therapy for depression

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in ecological momentary assessment scores
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
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)
Tidsram: 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
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
Change in the scores on the Difficulties in Emotion Regulation Scale (DERS)
Tidsram: 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
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 (HFERST)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the scores on the Questions on Life Satisfaction (FLZM)
Tidsram: 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)
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
Change in the scores on the Revised UCLA Loneliness Scale
Tidsram: 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
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy
Change in the scores on the Rosenberg's Self-Esteem Scale
Tidsram: 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
0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Heidelberg University

Utredare

  • Huvudutredare: Verena Zimmermann, M.Sc., Department of Clinical Psychology and Psychotherapy, Heidelberg University
  • Huvudutredare: Christina Timm, M.Sc., Department of Clinical Psychology and Psychotherapy, Heidelberg University
  • Huvudutredare: Annemarie Miano, PhD, Department of Clinical Psychology and Psychotherapy, Heidelberg University
  • Huvudutredare: Sven Barnow, Prof., Department of Clinical Psychology and Psychotherapy, Heidelberg University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 juni 2019

Primärt slutförande (Förväntat)

1 december 2021

Avslutad studie (Förväntat)

1 december 2021

Studieregistreringsdatum

Först inskickad

27 maj 2019

Först inskickad som uppfyllde QC-kriterierna

6 juni 2019

Första postat (Faktisk)

10 juni 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 april 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 april 2021

Senast verifierad

1 april 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Depression & ER

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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