Major Depressive DisorderKONNINCT03957850
Cognitive Reappraisal in Adolescents With Major Depression
A study testing Cognitive Reappraisal Training in people with Major Depressive Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Major depression (MD) is common during adolescence and associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation, including deficits in cognitive reappraisal (CR). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cognitive Reappraisal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2019to 22 Nov 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female and male participants
- age range: 12-18 years
- current diagnosis of MD (ICD-10 diagnoses F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2)
- intelligence quotient (IQ) of ≥ 80
Who cannot join
- neurological disorders
- schizophrenic disorder
- pervasive developmental disorder
- bipolar disorder
- borderline personality disorder
- substance dependence disorder
- gender dysphoria.
- Participants comorbid with psychiatric comorbidities other than those listed above are included if MD is the primary diagnosis.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany
Munich, Bavaria, 80336
About this study
Official title: Cognitive Reappraisal in Adolescents With Major Depression: From Neurobiological Mechanisms to Intervention
Major depression (MD) is common during adolescence and associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation, including deficits in cognitive reappraisal (CR). CR is a particularly effective emotion regulation strategy that aims at reinterpreting emotional events to modify affective responses. Adolescents with MD apply this strategy less often than their healthy peers and show disturbances in brain activation patterns underlying CR.
In this study, MD adolescents will be randomly assigned to a group that receives a task-based training in CR or to a control training group. It will be examined whether the task-based CR training is superior to the control training with regard to improvements in negative affect, perceived stress in daily life and depressive symptoms. Moreover, during the four training sessions, the event-related potential "Late Positive Potential" (LPP) will be recorded to assess neurophysiological indices of CR processes and gaze fixations on emotional areas within negative pictures and affective responses to pictures will be collected to identify mechanisms underlying training effects.This study will provide first evidence for the efficacy of a short-time training that has previously shown to be effective in healthy individuals. Moreover, the study will identify neurobiological mechanisms that predict training effects. The results of this investigation will lay the ground for a clinical trial to investigate whether a CR training added to an established intervention improves treatment effects for adolescent MD.
- Conditions
- Major Depressive Disorder
- Being tested
- Cognitive Reappraisal Training, Control Training
- Keywords
- Emotion Regulation Training, LPP, Adolescence, Major Depression, Eye-tracking, Cognitive Reappraisal, Event-related Potentials
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Reappraisal TrainingBehavioural
The training procedure is adapted from a study by Denny \& Ochsner (2014). Before the task, participants are instructed that they will be presented pictures and that these pictures will be preceded by a condition specific cue signaling the appropriate strategy during picture viewing. Participants are instructed to indicate their affective response to the image on a rating scale. The task involves 4 conditions: 1) Negative-decrease: participants are asked to view negative pictures and to decrease their affective response by reappraising the negative event. 2) Negative-attend/ 3) Neutral-attend/ 4) Positive-attend: participants are asked to view pictures and to respond naturally to them without trying to alter their affective response. The training task will be repeated over 4 training sessions.
Control TrainingBehavioural
The task in the control group is implemented to account for unspecific effects and is as similar as possible to the CR task except that it involves no negative-decrease (i.e., no reappraisal) condition. Instead, the control task only involves the three attend conditions (negative- attend, neutral-attend, positive-attend).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Reappraisal Training Group | Experimental | Cognitive Reappraisal Training group will perform 4 training sessions in Cognitive Reappraisal during which, behavioral responses, event-related potentials (ERPs) and eye-tracking data are collected. Receives: Behavioral: Cognitive Reappraisal Training |
| Control Training Group | Active comparator | Control Training Group will perform 4 control sessions without Cognitive Reappraisal Training during which behavioral responses, ERP and eye-tracking data are collected. Receives: Behavioral: Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in negative and positive affect via the Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
A change in negative affect will be assessed based on the Negative Affect scale of the PANAS-C-SF. This scale ranges from one to five, with higher scores indicating more negative affect. A change in positive affect will be assessed based on the Positive Affect scale of the PANAS-C-SF. This scale ranges from one to five, with higher scores indicating more positive affect.
Measured: Over the course of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (2 weeks after the end of the entire training).
Change in perceived stress via the Perceived Stress Scale (PSS-10)
Change in perceived stress will be assessed based on the German adaption of the PSS-10. This scale ranges from 1-5, with higher scores indicating more perceived stress.
Measured: During each of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (two weeks after the end of the training sessions).
Change in rumination as assessed via the German adaptation of the Response Style Questionnaire (RSQ-D)
Change in rumination will be assessed based on two separate rumination subscales of the RSQ-D. The self-focused rumination scale ranges from 7-28, with higher scores indicating higher self-focused rumination. The symptom-focused rumination scale ranges from 8-31, with higher scores indicating higher symptom-focused rumination.
Measured: Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (two weeks after the end of the training sessions).
Change in depressive Symptoms via the Beck Depression Inventory - Second Edition (BDI-II)
Change in depressive symptoms will be assessed based on the BDI-II. This scale ranges from 0-63, with higher scores indicated more depressive symptoms.
Measured: Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks.
Secondary outcomes (3)
Changes in the downregulation of affective behavioral responses to negative pictures via CR based on the self-assessment manikin scale
Affective behavioral responses to negative pictures will be continuously assessed during each of the four training sessions. This assessment is based on the self-assessment manikin scale for valence (Bradley \& Lang, 1994), which is a 9-point rating scale with higher scores indicating higher positive affect. To obtain a behavioral index of downregulated affect in the CR training group, averaged behavioral affective responses during an attend condition will be subtracted from averaged behavioral affective responses during an active regulate condition.
Measured: During each of the four training sessions, which will take place within the time frame of two weeks.
Changes in the downregulation of the LPP (late positive potential) to negative pictures via CR
The LPP elicited to negative pictures will be continuously assessed during each of the four training sessions. To calculate the downregulation of the LPP via CR in the CR training group, the averaged LPP during an attend condition will be subtracted from the averaged LPP during an active regulate condition.
Measured: During each of the four training sessions, which will take place within the time frame of two weeks.
Changes in the percent gaze fixations in emotional areas of interest within negative pictures
Changes in the percent duration of gaze fixations within a-priori defined emotional interest areas within negative pictures will be exploratively assessed over the course of the four training sessions.
Measured: During each of the four training sessions, which will take place within the time frame of two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start27 May 2019
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Parallel groups
- Model description
- This study is designed as a short-term randomized controlled, participant-blind clinical trial including two groups of adolescents with MD. MD participants will be randomly assigned to a group that receives task-based training in CR or to a control training. Randomisation will be performed by a statistician, stratifying for age (14 years and younger and 15 years and older) and sex.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, RWTH Aachen University, University of Amsterdam
- Responsible party
- Principal investigator, Ellen Greimel, Ludwig-Maximilians - University of Munich
- Investigators
- Ellen Greimel, PhD, Principal investigator, Department of Child&Adolescent Psychiatry, Psychosomatics&Psychoth.,LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957850
- Sponsor's protocol ID
- 399482529
- Acronym
- KONNI
- Status last verified
- Aug 2022
- First submitted
- 3 May 2019
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data in our study contains sensitive patient information, such as sociodemographic information and comorbidities. Since patients could possibly be identified by making our raw data publicly available, ethical principles of protecting patient confidentiality would be breached. Aggregated group data can be made available upon request.
Publications
Denny BT, Ochsner KN. Behavioral effects of longitudinal training in cognitive reappraisal. Emotion. 2014 Apr;14(2):425-33. doi: 10.1037/a0035276. Epub 2013 Dec 23.
PubMed 24364856Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
PubMed 7962581Zsigo C, Feldmann L, Oort F, Piechaczek C, Bartling J, Schulte-Ruther M, Wachinger C, Schulte-Korne G, Greimel E. Emotion regulation training for adolescents with major depression: Results from a randomized controlled trial. Emotion. 2024 Jun;24(4):975-991. doi: 10.1037/emo0001328. Epub 2023 Dec 7.
PubMed 38060020Greimel E, Feldmann L, Piechaczek C, Oort F, Bartling J, Schulte-Ruther M, Schulte-Korne G. Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study. BMJ Open. 2020 Sep 10;10(9):e036093. doi: 10.1136/bmjopen-2019-036093.
PubMed 32912977
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Reappraisal in Adolescents With Major Depression: From Neurobiological Mechanisms to Intervention
- ClinicalTrials.gov ID
- NCT03957850
- Acronym / sponsor ID
- KONNI / 399482529
- Conditions
- Major Depressive Disorder
- Keywords
- Emotion Regulation Training, LPP, Adolescence, Major Depression, Eye-tracking, Cognitive Reappraisal, Event-related Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- German Research Foundation, RWTH Aachen University, University of Amsterdam
- Study start
- 27 May 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 21 May 2019 (actual)
- 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.
Major depression (MD) is common during adolescence and associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation, including deficits in cognitive reappraisal (CR). CR is a particularly effective emotion regulation strategy that aims at reinterpreting emotional events to modify affective responses. Adolescents with MD apply this strategy less often than their healthy peers and show disturbances in brain activation patterns underlying CR.
In this study, MD adolescents will be randomly assigned to a group that receives a task-based training in CR or to a control training group. It will be examined whether the task-based CR training is superior to the control training with regard to improvements in negative affect, perceived stress in daily life and depressive symptoms. Moreover, during the four training sessions, the event-related potential "Late Positive Potential" (LPP) will be recorded to assess neurophysiological indices of CR processes and gaze fixations on emotional areas within negative pictures and affective responses to pictures will be collected to identify mechanisms underlying training effects.This study will provide first evidence for the efficacy of a short-time training that has previously shown to be effective in healthy individuals. Moreover, the study will identify neurobiological mechanisms that predict training effects. The results of this investigation will lay the ground for a clinical trial to investigate whether a CR training added to an established intervention improves treatment effects for adolescent MD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed as a short-term randomized controlled, participant-blind clinical trial including two groups of adolescents with MD. MD participants will be randomly assigned to a group that receives task-based training in CR or to a control training. Randomisation will be performed by a statistician, stratifying for age (14 years and younger and 15 years and older) and sex.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Reappraisal Training Group | Experimental | Behavioral: Cognitive Reappraisal TrainingCognitive Reappraisal Training group will perform 4 training sessions in Cognitive Reappraisal during which, behavioral responses, event-related potentials (ERPs) and eye-tracking data are collected. |
| Control Training Group | Active comparator | Behavioral: Control TrainingControl Training Group will perform 4 control sessions without Cognitive Reappraisal Training during which behavioral responses, ERP and eye-tracking data are collected. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female and male participants
- age range: 12-18 years
- current diagnosis of MD (ICD-10 diagnoses F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2)
- intelligence quotient (IQ) of ≥ 80
Key exclusion criteria (8 listed)
- neurological disorders
- schizophrenic disorder
- pervasive developmental disorder
- bipolar disorder
- borderline personality disorder
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 |
|---|---|---|
| Cognitive Reappraisal TrainingThe training procedure is adapted from a study by Denny \& Ochsner (2014). Before the task, participants are instructed that they will be presented pictures and that these pictures will be preceded by a condition specific cue signaling the appropriate strategy during picture viewing. Participants are instructed to indicate their affective response to the image on a rating scale. The task involves 4 conditions: 1) Negative-decrease: participants are asked to view negative pictures and to decrease their affective response by reappraising the negative event. 2) Negative-attend/ 3) Neutral-attend/ 4) Positive-attend: participants are asked to view pictures and to respond naturally to them without trying to alter their affective response. The training task will be repeated over 4 training sessions. | Behavioural | Cognitive Reappraisal Training Group |
| Control TrainingThe task in the control group is implemented to account for unspecific effects and is as similar as possible to the CR task except that it involves no negative-decrease (i.e., no reappraisal) condition. Instead, the control task only involves the three attend conditions (negative- attend, neutral-attend, positive-attend). | Behavioural | Control Training Group |
Primary outcome
Change in negative and positive affect via the Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
Time frame: Over the course of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (2 weeks after the end of the entire training).
A change in negative affect will be assessed based on the Negative Affect scale of the PANAS-C-SF. This scale ranges from one to five, with higher scores indicating more negative affect. A change in positive affect will be assessed based on the Positive Affect scale of the PANAS-C-SF. This scale ranges from one to five, with higher scores indicating more positive affect.
Change in perceived stress via the Perceived Stress Scale (PSS-10)
Time frame: During each of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (two weeks after the end of the training sessions).
Change in perceived stress will be assessed based on the German adaption of the PSS-10. This scale ranges from 1-5, with higher scores indicating more perceived stress.
Change in rumination as assessed via the German adaptation of the Response Style Questionnaire (RSQ-D)
Time frame: Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (two weeks after the end of the training sessions).
Change in rumination will be assessed based on two separate rumination subscales of the RSQ-D. The self-focused rumination scale ranges from 7-28, with higher scores indicating higher self-focused rumination. The symptom-focused rumination scale ranges from 8-31, with higher scores indicating higher symptom-focused rumination.
Change in depressive Symptoms via the Beck Depression Inventory - Second Edition (BDI-II)
Time frame: Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks.
Change in depressive symptoms will be assessed based on the BDI-II. This scale ranges from 0-63, with higher scores indicated more depressive symptoms.
3 secondary outcomes
Changes in the downregulation of affective behavioral responses to negative pictures via CR based on the self-assessment manikin scale
Time frame: During each of the four training sessions, which will take place within the time frame of two weeks.
Changes in the downregulation of the LPP (late positive potential) to negative pictures via CR
Time frame: During each of the four training sessions, which will take place within the time frame of two weeks.
Changes in the percent gaze fixations in emotional areas of interest within negative pictures
Time frame: During each of the four training sessions, which will take place within the time frame of two weeks.
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 23 Aug 2022.
- Background: PubMed 24364856Denny BT, Ochsner KN. Behavioral effects of longitudinal training in cognitive reappraisal. Emotion. 2014 Apr;14(2):425-33. doi: 10.1037/a0035276. Epub 2013 Dec 23.
- Background: PubMed 7962581Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
- Derived from this study: PubMed 38060020Zsigo C, Feldmann L, Oort F, Piechaczek C, Bartling J, Schulte-Ruther M, Wachinger C, Schulte-Korne G, Greimel E. Emotion regulation training for adolescents with major depression: Results from a randomized controlled trial. Emotion. 2024 Jun;24(4):975-991. doi: 10.1037/emo0001328. Epub 2023 Dec 7.
- Derived from this study: PubMed 32912977Greimel E, Feldmann L, Piechaczek C, Oort F, Bartling J, Schulte-Ruther M, Schulte-Korne G. Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study. BMJ Open. 2020 Sep 10;10(9):e036093. doi: 10.1136/bmjopen-2019-036093.
- Individual participant dataSharing planned: No. Data in our study contains sensitive patient information, such as sociodemographic information and comorbidities. Since patients could possibly be identified by making our raw data publicly available, ethical principles of protecting patient confidentiality would be breached. Aggregated group data can be made available upon request.
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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.
Ellen Greimel, PhD principal investigator
Department of Child&Adolescent Psychiatry, Psychosomatics&Psychoth.,LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Reappraisal Training in people with Major Depressive Disorder, run by Ludwig-Maximilians - University of Munich 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 4 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: finished, as of the sponsor's last update on 23 Aug 2022. 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?
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 negative and positive affect via the Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF) (time frame: Over the course of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (2 weeks after the end of the entire training).). The study lists 4 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 NCT03957850, which also lists 4 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 23 Aug 2022.