Bipolar DisorderA2BipoLifeNCT02506322
Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
A study testing SEKT - Cognitive-Behavioral-Emotional and FEST - Clinical Supportive Educational in people with Bipolar Disorder, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- SEKT - Cognitive-Behavioral-Emotional and FEST - Clinical Supportive Educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2015to 31 Mar 2020
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bipolar I and Bipolar II Disorder,
- 18 to 55 years of age,
- giving informed consent to assessment, treatment, and randomization,
- currently remitted (for at least 4 weeks) and taking medication,
- less than 6 previous affective episodes
Who cannot join
- currently symptomatic (depressed, manic, hypomanic),
- suicidal,
- not taking medication,
- schizo-affective, schizophrenic, borderline personality disorder,
- not giving or withdrawing consent
Trial locations and contacts
1 site in 1 country.
About this study
This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.
Read the detailed description
There is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in Bipolar Disorder. By treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. In addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). Possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). The planned study will address all three areas of questions. In a multi-center study, 300 younger subjects suffering of a Bipolar Disorder will be included and provide with one of two treatments in addition to stable medication. Moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of Bipolar Disorder.
- Conditions
- Bipolar Disorder
- Being tested
- SEKT - Cognitive-Behavioral-Emotional, FEST - Clinical Supportive Educational
- Keywords
- Bipolar I Disorder, Bipolar II Disorder, Relapse Prevention
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEKT - Cognitive-Behavioral-EmotionalBehavioural
Also called Specific Psychotherapy for Bipolar Disorder
This Bipolar Disorder specific psychotherapy has 4 modules:
- psychoeducation, life chart, relapse experiences, personalized explanation, early symptoms and recognition of a new episode, self observation
- Stress regulation, sleep-wake cycle, social rhythm, daily and weekly structure of life, life balance
- dysfunctional cognitions, cognitive techniques, meta-cognitive techniques, emotion regulation methods
- behavior changes, (social, problem solving) skill training, communication skills, crisis management
FEST - Clinical Supportive EducationalBehavioural
Also called Supportive, non-specific psychotherapy for Bipolar Disorder
This active control psychotherapy has 2 modules: (a) psychoeducation about Bipolar Disorder, the etiology and development of this disorder, drug options, effects and side effects of medication, compliance, how to handle unwanted side effects (b) group discussion and exchange about disorder relevant and personal relevant topics related to Bipolar Disorder, therapist is passive, encouraging, listening, verbalizing feelings and emotion, strengthening subjects resources
| Study group | Role | What they receive |
|---|---|---|
| SEKT Cognitive-Behavioral-Emotional | Experimental | Specific psychotherapy (SEKT - 4 modules) for typical problems of Bipolar patients to maintain remission and to prevent relapse. Including classical elements of self observation, psychoeducation, cognitive and behavioral interventions, social rhythm but also emotion regulation and meta-cognitive techniques. Delivered in a group setting in 4 one day treatment workshops, each one month apart. Homework assignment and electronical monitoring during time between sessions. Receives: Behavioral: SEKT - Cognitive-Behavioral-Emotional |
| FEST Clinical Supportive Educational | Active comparator | This supportive, active control psychotherapy (FEST) is using general principals and non-specific interventions such as positive attitude, optimism, support, empathy, focus on emotion, self-help, strengthening and eliciting own resources, time and room for discussion of personal experiences. Psychoeducation about illness and drug treatment (mood stabilizer) to facilitate compliance. Receives: Behavioral: FEST - Clinical Supportive Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to new affective episode
At baseline, subjects have to be remitted. Psychotherapies focus on maintenance and relapse prevention. Relapse will be assessed by LIFE interview every six month
Measured: 18 months
Secondary outcomes (4)
Qick-Inventory of Depressive Symptoms
Clinician ratings of depressive symptoms
Measured: 18 months
Social functioning
Clinician rating social functioning (GAF)
Measured: 18 months
Neurobiological changes (functional, genetic) (functional MRI)
functional MRI at baseline and after six month
Measured: 6 months
Young Mania Rating Scale
Clinician ratings of manic symptoms
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Dresden, University Hospital Goettingen, Ludwig-Maximilians - University of Munich, Universitätsklinikum Hamburg-Eppendorf, University Hospital Bergmannsheil Bochum, Charite University, Berlin, Germany, Philipps University Marburg, Goethe University, Ruppiner Clinic, Psychiatric Clinic, Neuruppin
- Responsible party
- Principal investigator, Prof. Dr. Martin Hautzinger, University Hospital Tuebingen
- Investigators
- Martin HAUTZINGER, PhD, Principal investigator, Department Psychology University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506322
- Sponsor's protocol ID
- 01EE1404C
- Acronym
- A2BipoLife
- Status last verified
- Nov 2020
- First submitted
- 19 Dec 2014
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meyer TD, Hautzinger M. Cognitive behaviour therapy and supportive therapy for bipolar disorders: relapse rates for treatment period and 2-year follow-up. Psychol Med. 2012 Jul;42(7):1429-39. doi: 10.1017/S0033291711002522. Epub 2011 Nov 21.
PubMed 22099722Hautzinger M; A2 BipoLife Consortium. Adjuvant Psychotherapies to Prevent Relapse in Bipolar Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Sep 1;81(9):855-862. doi: 10.1001/jamapsychiatry.2024.1310.
PubMed 38837133Thomas-Odenthal F, Stein F, Vogelbacher C, Alexander N, Bechdolf A, Bermpohl F, Brockel K, Brosch K, Correll CU, Evermann U, Falkenberg I, Fallgatter A, Flinkenflugel K, Grotegerd D, Hahn T, Hautzinger M, Jansen A, Juckel G, Krug A, Lambert M, Leicht G, Leopold K, Meinert S, Mikolas P, Mulert C, Nenadic I, Pfarr JK, Reif A, Ringwald K, Ritter P, Stamm T, Straube B, Teutenberg L, Thiel K, Usemann P, Winter A, Wroblewski A, Dannlowski U, Bauer M, Pfennig A, Kircher T. Larger putamen in individuals at risk and with manifest bipolar disorder. Psychol Med. 2024 Aug;54(11):3071-3081. doi: 10.1017/S0033291724001193. Epub 2024 May 27.
PubMed 38801091Meyer K, Hindi Attar C, Fiebig J, Stamm T, Bassett TR, Bauer M, Dannlowski U, Ethofer T, Falkenberg I, Jansen A, Juckel G, Kircher T, Mulert C, Leicht G, Rau A, Ritter D, Ritter P, Trost S, Vogelbacher C, Walter H, Wolter S, Hautzinger M, Bermpohl F. Boosting the Theory of Mind Network: Specific Psychotherapy Increases Neural Correlates of Affective Theory of Mind in Euthymic Bipolar Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 May;8(5):572-580. doi: 10.1016/j.bpsc.2022.08.013. Epub 2022 Sep 8.
PubMed 36087699Stamm TJ, Zwick JC, O'Malley G, Sondergeld LM, Hautzinger M. Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial. Trials. 2020 Oct 13;21(1):845. doi: 10.1186/s13063-020-04755-8.
PubMed 33050952
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02506322
- Acronym / sponsor ID
- A2BipoLife / 01EE1404C
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder, Bipolar II Disorder, Relapse Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Dresden, University Hospital Goettingen, Ludwig-Maximilians - University of Munich, Universitätsklinikum Hamburg-Eppendorf, University Hospital Bergmannsheil Bochum, Charite University, Berlin, Germany, Philipps University Marburg, Goethe University, Ruppiner Clinic, Psychiatric Clinic, Neuruppin
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Jul 2015 (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.
This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.
Detailed description
There is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in Bipolar Disorder. By treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. In addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). Possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). The planned study will address all three areas of questions. In a multi-center study, 300 younger subjects suffering of a Bipolar Disorder will be included and provide with one of two treatments in addition to stable medication. Moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of Bipolar Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEKT Cognitive-Behavioral-Emotional | Experimental | Behavioral: SEKT - Cognitive-Behavioral-EmotionalSpecific psychotherapy (SEKT - 4 modules) for typical problems of Bipolar patients to maintain remission and to prevent relapse. Including classical elements of self observation, psychoeducation, cognitive and behavioral interventions, social rhythm but also emotion regulation and meta-cognitive techniques. Delivered in a group setting in 4 one day treatment workshops, each one month apart. Homework assignment and electronical monitoring during time between sessions. |
| FEST Clinical Supportive Educational | Active comparator | Behavioral: FEST - Clinical Supportive EducationalThis supportive, active control psychotherapy (FEST) is using general principals and non-specific interventions such as positive attitude, optimism, support, empathy, focus on emotion, self-help, strengthening and eliciting own resources, time and room for discussion of personal experiences. Psychoeducation about illness and drug treatment (mood stabilizer) to facilitate compliance. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Bipolar I and Bipolar II Disorder,
- 18 to 55 years of age,
- giving informed consent to assessment, treatment, and randomization,
- currently remitted (for at least 4 weeks) and taking medication,
- less than 6 previous affective episodes
Key exclusion criteria (5 listed)
- currently symptomatic (depressed, manic, hypomanic),
- suicidal,
- not taking medication,
- schizo-affective, schizophrenic, borderline personality disorder,
- not giving or withdrawing consent
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 |
|---|---|---|
| SEKT - Cognitive-Behavioral-EmotionalAlso: Specific Psychotherapy for Bipolar DisorderThis Bipolar Disorder specific psychotherapy has 4 modules: 1. psychoeducation, life chart, relapse experiences, personalized explanation, early symptoms and recognition of a new episode, self observation 2. Stress regulation, sleep-wake cycle, social rhythm, daily and weekly structure of life, life balance 3. dysfunctional cognitions, cognitive techniques, meta-cognitive techniques, emotion regulation methods 4. behavior changes, (social, problem solving) skill training, communication skills, crisis management | Behavioural | SEKT Cognitive-Behavioral-Emotional |
| FEST - Clinical Supportive EducationalAlso: Supportive, non-specific psychotherapy for Bipolar DisorderThis active control psychotherapy has 2 modules: (a) psychoeducation about Bipolar Disorder, the etiology and development of this disorder, drug options, effects and side effects of medication, compliance, how to handle unwanted side effects (b) group discussion and exchange about disorder relevant and personal relevant topics related to Bipolar Disorder, therapist is passive, encouraging, listening, verbalizing feelings and emotion, strengthening subjects resources | Behavioural | FEST Clinical Supportive Educational |
Primary outcome
Time to new affective episode
Time frame: 18 months
At baseline, subjects have to be remitted. Psychotherapies focus on maintenance and relapse prevention. Relapse will be assessed by LIFE interview every six month
4 secondary outcomes
Qick-Inventory of Depressive Symptoms
Time frame: 18 months
Social functioning
Time frame: 18 months
Neurobiological changes (functional, genetic) (functional MRI)
Time frame: 6 months
Young Mania Rating Scale
Time frame: 18 months
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 4 Nov 2020.
- Background: PubMed 22099722Meyer TD, Hautzinger M. Cognitive behaviour therapy and supportive therapy for bipolar disorders: relapse rates for treatment period and 2-year follow-up. Psychol Med. 2012 Jul;42(7):1429-39. doi: 10.1017/S0033291711002522. Epub 2011 Nov 21.
- Derived from this study: PubMed 38837133Hautzinger M; A2 BipoLife Consortium. Adjuvant Psychotherapies to Prevent Relapse in Bipolar Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Sep 1;81(9):855-862. doi: 10.1001/jamapsychiatry.2024.1310.
- Derived from this study: PubMed 38801091Thomas-Odenthal F, Stein F, Vogelbacher C, Alexander N, Bechdolf A, Bermpohl F, Brockel K, Brosch K, Correll CU, Evermann U, Falkenberg I, Fallgatter A, Flinkenflugel K, Grotegerd D, Hahn T, Hautzinger M, Jansen A, Juckel G, Krug A, Lambert M, Leicht G, Leopold K, Meinert S, Mikolas P, Mulert C, Nenadic I, Pfarr JK, Reif A, Ringwald K, Ritter P, Stamm T, Straube B, Teutenberg L, Thiel K, Usemann P, Winter A, Wroblewski A, Dannlowski U, Bauer M, Pfennig A, Kircher T. Larger putamen in individuals at risk and with manifest bipolar disorder. Psychol Med. 2024 Aug;54(11):3071-3081. doi: 10.1017/S0033291724001193. Epub 2024 May 27.
- Derived from this study: PubMed 36087699Meyer K, Hindi Attar C, Fiebig J, Stamm T, Bassett TR, Bauer M, Dannlowski U, Ethofer T, Falkenberg I, Jansen A, Juckel G, Kircher T, Mulert C, Leicht G, Rau A, Ritter D, Ritter P, Trost S, Vogelbacher C, Walter H, Wolter S, Hautzinger M, Bermpohl F. Boosting the Theory of Mind Network: Specific Psychotherapy Increases Neural Correlates of Affective Theory of Mind in Euthymic Bipolar Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 May;8(5):572-580. doi: 10.1016/j.bpsc.2022.08.013. Epub 2022 Sep 8.
- Derived from this study: PubMed 33050952Stamm TJ, Zwick JC, O'Malley G, Sondergeld LM, Hautzinger M. Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial. Trials. 2020 Oct 13;21(1):845. doi: 10.1186/s13063-020-04755-8.
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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.
Martin HAUTZINGER, PhD principal investigator
Department Psychology University Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEKT - Cognitive-Behavioral-Emotional and FEST - Clinical Supportive Educational in people with Bipolar Disorder, run by University Hospital Tuebingen 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 5 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 4 Nov 2020. 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?
Time to new affective episode (time frame: 18 months). 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 NCT02506322, which also lists 5 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 4 Nov 2020.