NCT03979963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

May 27, 2019

Last Update Submit

April 26, 2021

Conditions

Depression

Keywords

DepressionEmotion RegulationCognitive Behavioral TherapyEcological Momentary Assessment

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Change in the scores on the Questions on Life Satisfaction (FLZM)

    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

    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

    0, 3, 6, 9, 12, 15, 18, 21, and 24 months after completion of cognitive behavioral therapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have recently completed outpatient cognitive behavioral therapy for depression

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heidelberg, 69117, Germany

RECRUITING

Related Publications (18)

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

    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.

    BACKGROUND

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

    BACKGROUND

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

    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.

    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.

    BACKGROUND

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

    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.

    BACKGROUND

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

    BACKGROUND

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

    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.

    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.

    PMID: 28730850BACKGROUND

  • 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.

    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.

    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.

    BACKGROUND

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

    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.

    PMID: 7431205BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

DepressionEmotional Regulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Verena Zimmermann, M.Sc.

CONTACT

+49 6221 547295verena.zimmermann@psychologie.uni-heidelberg.de

Christina Timm, M.Sc.

CONTACT

+49 6221 547715christina.timm@psychologie.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 10, 2019

Study Start

June 3, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations

DE(1)