Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

Depression Clinical Trial

Official title:

Depressive Symptoms and Emotion Regulation Following Outpatient Cognitive Behavioral Therapy for Depression: a Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979963
• Other study ID #: Depression & ER
• Status: Recruiting
• Start date: June 3, 2019
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Heidelberg University
• Contact: Verena Zimmermann, M.Sc.
• Phone: +49 6221 547295
• Email: verena.zimmermann[@]psychologie.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (18)

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. — View Citation

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. — View Citation

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.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ecological momentary assessment scores	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
Primary	Change in the mental disorders diagnosed with the Structured Clinical Interview for DSM-5 (SCID-5)	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
Primary	Change in the score on the Beck Depression Inventory-II (BDI-II)	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
Primary	Change in the score on the WHO (Five) Well-Being Index (WHO-5)	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
Primary	Change in the scores on the Brief-Symptom-Checklist (BSCL)	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
Primary	Change in the scores on the Center for Epidemiologic Studies Depression Scale (CES-D)	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
Primary	Change in the scores on the Difficulties in Emotion Regulation Scale (DERS)	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
Primary	Change in the scores on the Heidelberg Form for Emotion Regulation Strategies (HFERST)	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
Secondary	Change in the scores on the Questions on Life Satisfaction (FLZM)	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
Secondary	Change in the scores on the Revised UCLA Loneliness Scale	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
Secondary	Change in the scores on the Rosenberg's Self-Esteem Scale	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