Major Depressive DisorderNCT01330485
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
A study testing Affect Regulation Training in people with Major Depressive Disorder, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 3 sites in Germany.
Trial summary
The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Affect Regulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 3 sitesGermany
- Study dates
- Nov 2010to Sep 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of MDD according to DSM-IV criteria as the primary diagnosis
- age 18 and above
- sufficient German language skills
Who cannot join
- high risk of suicide
- indication of substantial secondary gain
- currently in psychotherapeutic treatment with an institution/professional other than those involved in the study
- co-occurring psychotic, bi-polar, and/or substance disorders
- organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie
Kassel, 34119
University of Mainz
Mainz, D-55122
Philipps-University of Marburg
Marburg, Hesse, 35032
About this study
The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).
Read the detailed description
Deficits in general emotion regulation skills have been shown to be associated with various mental disorders. Thus, general affect-regulation training has been proposed as promising transdiagnostic approach to the treatment of psychopathology. In the present study, we aimed to evaluate the efficacy of a general affect-regulation as a stand-alone, group-based treatment for depression. For this purpose, we randomly assigned 218 individuals who met criteria for major depressive disorder (MDD) to the Affect Regulation Training (ART), to a waitlist control condition (WLC), or to a condition controlling for common factors (CFC). The primary outcome was the course of depressive symptom severity as assessed with the Hamilton Rating Scale for Depression and the Beck Depression Inventory. Differences between groups will be analyzed with the help of multi-level analyses. To clarify mechanisms of change we will test whether changes in emotion regulation skills will mediate potential differences between conditions regarding change of depressive symptoms. As secondary goal, the study will try and clarify whether participating in ART might augment the efficacy of subsequent individual cognitive-behavioral therapy.
- Conditions
- Major Depressive Disorder
- Being tested
- Affect Regulation Training, Common Factor Control Condition
- Keywords
- depression, emotion regulation, affect regulation, skills, randomized controlled trial, mediation
- Medical subject headings
- Depressive Disorder, Major, Depression, Emotional Regulation, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affect Regulation TrainingBehavioural
Also called ART
The ART is a transdiagnostic, group-based intervention that has been developed to explicitly target emotion regulation skills (e.g., the abilities to be aware of, understand, accept, tolerate and modify negative emotions).
Common Factor Control ConditionBehavioural
Also called CFC
The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
| Study group | Role | What they receive |
|---|---|---|
| Affect Regulation Training | Experimental | Affect Regulation Training as described in Berking \& Whitley, 2014. Receives: Behavioral: Affect Regulation Training |
| Common Factor Control Condition (CFC) | Active comparator | Common factor based therapy control condition Receives: Behavioral: Common Factor Control Condition |
| Waitlist Control Condition | No intervention | Wait List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms
Change in depressive symptoms as assessed in Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD) and aggregated to a composite score is possible
Measured: Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later
Secondary outcomes (1)
Emotion regulation skills
Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire
Measured: Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Group (3 groups) x time
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Matthias Berking, Ph.D., Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Matthias Berking, Prof. Dr., Principal investigator, Friedrich-Alexander-University Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330485
- Sponsor's protocol ID
- BE4510/3-1
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2011
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified IPD will be made available to other researchers upon reguest.
Publications
Eichler E, Hager M, Baeuml J, Berking M. Emotion regulation as mechanism of change in the treatment of depression - A latent change score analysis. J Affect Disord. 2026 Jan 1;392:120205. doi: 10.1016/j.jad.2025.120205. Epub 2025 Sep 2.
PubMed 40907712Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W. Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019.
PubMed 31465443Ehret AM, Kowalsky J, Rief W, Hiller W, Berking M. Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial. BMC Psychiatry. 2014 Jan 27;14:20. doi: 10.1186/1471-244X-14-20.
PubMed 24467807
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01330485
- Acronym / sponsor ID
- BE4510/3-1
- Conditions
- Major Depressive Disorder
- Keywords
- depression, emotion regulation, affect regulation, skills, randomized controlled trial, mediation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Nov 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).
Detailed description
Deficits in general emotion regulation skills have been shown to be associated with various mental disorders. Thus, general affect-regulation training has been proposed as promising transdiagnostic approach to the treatment of psychopathology. In the present study, we aimed to evaluate the efficacy of a general affect-regulation as a stand-alone, group-based treatment for depression. For this purpose, we randomly assigned 218 individuals who met criteria for major depressive disorder (MDD) to the Affect Regulation Training (ART), to a waitlist control condition (WLC), or to a condition controlling for common factors (CFC). The primary outcome was the course of depressive symptom severity as assessed with the Hamilton Rating Scale for Depression and the Beck Depression Inventory. Differences between groups will be analyzed with the help of multi-level analyses. To clarify mechanisms of change we will test whether changes in emotion regulation skills will mediate potential differences between conditions regarding change of depressive symptoms. As secondary goal, the study will try and clarify whether participating in ART might augment the efficacy of subsequent individual cognitive-behavioral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Group (3 groups) x time
| Arm | Type | Receives |
|---|---|---|
| Affect Regulation Training | Experimental | Behavioral: Affect Regulation TrainingAffect Regulation Training as described in Berking \& Whitley, 2014. |
| Common Factor Control Condition (CFC) | Active comparator | Behavioral: Common Factor Control ConditionCommon factor based therapy control condition |
| Waitlist Control Condition | No intervention | –Wait List Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of MDD according to DSM-IV criteria as the primary diagnosis
- age 18 and above
- sufficient German language skills
Key exclusion criteria (5 listed)
- high risk of suicide
- indication of substantial secondary gain
- currently in psychotherapeutic treatment with an institution/professional other than those involved in the study
- co-occurring psychotic, bi-polar, and/or substance disorders
- organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affect Regulation TrainingAlso: ARTThe ART is a transdiagnostic, group-based intervention that has been developed to explicitly target emotion regulation skills (e.g., the abilities to be aware of, understand, accept, tolerate and modify negative emotions). | Behavioural | Affect Regulation Training |
| Common Factor Control ConditionAlso: CFCThe CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions. | Behavioural | Common Factor Control Condition (CFC) |
Primary outcome
Change in depressive symptoms
Time frame: Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later
Change in depressive symptoms as assessed in Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD) and aggregated to a composite score is possible
1 secondary outcome
Emotion regulation skills
Time frame: Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 40907712Eichler E, Hager M, Baeuml J, Berking M. Emotion regulation as mechanism of change in the treatment of depression - A latent change score analysis. J Affect Disord. 2026 Jan 1;392:120205. doi: 10.1016/j.jad.2025.120205. Epub 2025 Sep 2.
- Derived from this study: PubMed 31465443Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W. Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019.
- Derived from this study: PubMed 24467807Ehret AM, Kowalsky J, Rief W, Hiller W, Berking M. Reducing symptoms of major depressive disorder through a systematic training of general emotion regulation skills: protocol of a randomized controlled trial. BMC Psychiatry. 2014 Jan 27;14:20. doi: 10.1186/1471-244X-14-20.
- Individual participant dataSharing planned: Yes. Deidentified IPD will be made available to other researchers upon reguest.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Berking, Prof. Dr. principal investigator
Friedrich-Alexander-University Erlangen-Nuremberg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affect Regulation Training in people with Major Depressive Disorder, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 3 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (time frame: Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later). 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 NCT01330485, which also lists 3 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 10 Apr 2019.