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DepressionNCT03979963

Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

An observational study of Depression, run by Heidelberg University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Depression
How many people
100 participants
Where
1 siteGermany
Study dates
3 Jun 2019to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals who have recently completed outpatient cognitive behavioral therapy for depression

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Verena Zimmermann, M.Sc. contact

+49 6221 547295

verena.zimmermann@psychologie.uni-heidelberg.de

Christina Timm, M.Sc. contact

+49 6221 547715

christina.timm@psychologie.uni-heidelberg.de

Germany1 site, 1 recruiting

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

    Heidelberg, 69117

    Verena Zimmermann, M.Sc., +49 6221 547295, verena.zimmermann@psychologie.uni-heidelberg.de

    Christina Timm, M.Sc., +49 6221 547715, christina.timm@psychologie.uni-heidelberg.de

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Conditions
Depression
Keywords
Depression, Emotion Regulation, Cognitive Behavioral Therapy, Ecological Momentary Assessment
Medical subject headings
Depression, Emotional Regulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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

    Measured: 0, 6, 12, and 24 months after completion of cognitive behavioral therapy

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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

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

  7. 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

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

  8. 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)

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

Secondary outcomes (3)

  1. Change in the scores on the Questions on Life Satisfaction (FLZM)

    Change in the scores on the Questions on Life Satisfaction (German Questionnaire)

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

  2. Change in the scores on the Revised UCLA Loneliness Scale

    Change in the scores on the German version of the Revised UCLA Loneliness Scale

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2019
  2. Study start3 Jun 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03979963
Sponsor's protocol ID
Depression & ER
Status last verified
Apr 2021
First submitted
27 May 2019
Last updated
27 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

  • 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.

    PubMed 28730850

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Verena Zimmermann, M.Sc. (+49 6221 547295, verena.zimmermann@psychologie.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03979963, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.

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