Depression ChronicPAUSENCT04159285
Psychotherapeutic Augmentation of Brain Stimulation Effects
A study testing EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients and Treatment as usual in people with Depression Chronic and Depression, Unipolar, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study aims to investigate effectiveness and feasability of a 15-week group psychotherapeutic intervention as continuation treatment after electroconvulsive therapy in severely depressed patients. Feasibility and acceptance of the half-open manualized CBT intervention are assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Chronic, Depression, Unipolar, Treatment Resistant Depression
- What is being tested?
- EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jan 2019to 15 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- treated with ECT for major depression
Who cannot join
- severe comorbid personality disorders
- principal diagnosis other than depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmenting and Sustaining Electroconvulsive Therapy (ECT) Treatment Effects by Group Cognitive Behavioural Therapy (CBT) in Unipolar Depressed Patients
This study aims to investigate effectiveness and feasability of a 15-week group psychotherapeutic intervention as continuation treatment after electroconvulsive therapy in severely depressed patients. Feasibility and acceptance of the half-open manualized CBT intervention are assessed. Depressive symptoms, quality of life and emotion regulation skills will be assessed before ECT treatment, before and after the 15-week group CBT intervention and at a 6 months follow-up after treatment end and compared to depressed patients treated with ECT who did not partake in group CBT. Moreover, patients will attend two indidivual pre-group sessions with one of the group therapist and one individual post-group session
Read the detailed description
While Electroconvulsive therapy (ECT) is a highly effective anti-depressant treatment, a relevant number of patients experience recurrence of depressive episodes within 6 months.
One previous study suggested that ECT treatment effects can be effectively sustained by group CBT (Cognitive Behavioral Therapy, Brakemeier et a. 2014). This previous implementation used a closed CBT-group set-up that implicated a longer waiting period for patients after finishing the acute ECT and did not investigate whether patients who did not respond to ECT could sufficiently profit from group CBT. In order to suit the complex needs of patients in a natural clinical setting, the present study aims to investigate the feasibility and effectiveness of a half-open continuous group CBT (named EffECtive 2.0) as continuation treatment for all ECT patients regardless of remission status after ECT.
This prospective study will recruit a total of 30 patients who concluded treatment with right-unilateral ultra-brief ECT for depression. Patients self-allocate to the group that is offered in addition to continuation treatment as usual (TAU, e.g. pharmacological treatment, continuation ECT, individual psychotherapy). ECT completers who choose not to partake in the group for practical concerns or lack of interest and receive treatment as usual are recruited as a control group.
The primary outcome measure is the change depression severity, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes are quality of life assessed with the short-version of the WHO quality of life questionnaire (WHOQOL-Bref) and emotion regulation as assessed with cognitive emotion regulation questionnaire (CERQ). These measures will be assessed before, during, immediately after acute ECT and six and 12 months into continuation therapy.
It is hypothesized that a group CBT as add-on treatment to TAU will lead to more favorable outcomes concerning depression severity, quality of life and emotion regulation.
- Being tested
- EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients, Treatment as usual
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patientsBehavioural
Group CBT with a maximum number of 8 participants. Group is half-open allowing a starting date right after completion of acute ECT treatment. Patients participate for 15 sessions, which are framed by 2 individual sessions before joining the group and one individual session at treatment end.
Treatment as usualOther
Can include continuation ECT, psychopharmacological treatment, individual psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group CBT | Experimental | 15-week group CBT with a focus on improvement of social interactions by cognitive re-modelling and role plays. Patients may simultaneously receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication. Receives: Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients; Other: Treatment as usual |
| Treatment as Usual | Experimental | Patients may receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinican-Rated Depressive Symptoms at treatment end
MADRS
Measured: End of group therapy treatment (~6 months after ECT treatment)
Clinican-Rated Depressive Symptoms at follow-up
MADRS
Measured: 6 months after end of group therapy
Secondary outcomes (4)
Quality of life at follow-up
WHOQL-Bref
Measured: 6 months after end of group therapy
Emotion regulation capacities at follow-up
Cognitive Emotion Regulation Questionnaire
Measured: 6 months after end of group therapy
Self-Reported Depressive Symptoms at treatment end
BDI
Measured: End of group therapy treatment (~6 months after ECT treatment)
Self-Reported Depressive Symptoms at follow up
BDI
Measured: 6 months after end of group therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start5 Jan 2019
- Primary completion1 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression ChronicStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Grimm, Charite University, Berlin, Germany
- Investigators
- Simone Grimm, Prof. Dr., Principal investigator, Charite Universitaetsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159285
- Sponsor's protocol ID
- PAUSE
- Acronym
- PAUSE
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brakemeier EL, Merkl A, Wilbertz G, Quante A, Regen F, Buhrsch N, van Hall F, Kischkel E, Danker-Hopfe H, Anghelescu I, Heuser I, Kathmann N, Bajbouj M. Cognitive-behavioral therapy as continuation treatment to sustain response after electroconvulsive therapy in depression: a randomized controlled trial. Biol Psychiatry. 2014 Aug 1;76(3):194-202. doi: 10.1016/j.biopsych.2013.11.030. Epub 2013 Dec 12.
PubMed 24462229
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting and Sustaining Electroconvulsive Therapy (ECT) Treatment Effects by Group Cognitive Behavioural Therapy (CBT) in Unipolar Depressed Patients
- ClinicalTrials.gov ID
- NCT04159285
- Acronym / sponsor ID
- PAUSE / PAUSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 12 Nov 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.
This study aims to investigate effectiveness and feasability of a 15-week group psychotherapeutic intervention as continuation treatment after electroconvulsive therapy in severely depressed patients. Feasibility and acceptance of the half-open manualized CBT intervention are assessed. Depressive symptoms, quality of life and emotion regulation skills will be assessed before ECT treatment, before and after the 15-week group CBT intervention and at a 6 months follow-up after treatment end and compared to depressed patients treated with ECT who did not partake in group CBT. Moreover, patients will attend two indidivual pre-group sessions with one of the group therapist and one individual post-group session
Detailed description
While Electroconvulsive therapy (ECT) is a highly effective anti-depressant treatment, a relevant number of patients experience recurrence of depressive episodes within 6 months.
One previous study suggested that ECT treatment effects can be effectively sustained by group CBT (Cognitive Behavioral Therapy, Brakemeier et a. 2014). This previous implementation used a closed CBT-group set-up that implicated a longer waiting period for patients after finishing the acute ECT and did not investigate whether patients who did not respond to ECT could sufficiently profit from group CBT. In order to suit the complex needs of patients in a natural clinical setting, the present study aims to investigate the feasibility and effectiveness of a half-open continuous group CBT (named EffECtive 2.0) as continuation treatment for all ECT patients regardless of remission status after ECT.
This prospective study will recruit a total of 30 patients who concluded treatment with right-unilateral ultra-brief ECT for depression. Patients self-allocate to the group that is offered in addition to continuation treatment as usual (TAU, e.g. pharmacological treatment, continuation ECT, individual psychotherapy). ECT completers who choose not to partake in the group for practical concerns or lack of interest and receive treatment as usual are recruited as a control group.
The primary outcome measure is the change depression severity, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes are quality of life assessed with the short-version of the WHO quality of life questionnaire (WHOQOL-Bref) and emotion regulation as assessed with cognitive emotion regulation questionnaire (CERQ). These measures will be assessed before, during, immediately after acute ECT and six and 12 months into continuation therapy.
It is hypothesized that a group CBT as add-on treatment to TAU will lead to more favorable outcomes concerning depression severity, quality of life and emotion regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CBT | Experimental | Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients, Other: Treatment as usual15-week group CBT with a focus on improvement of social interactions by cognitive re-modelling and role plays. Patients may simultaneously receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication. |
| Treatment as Usual | Experimental | Other: Treatment as usualPatients may receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- treated with ECT for major depression
Key exclusion criteria (2 listed)
- severe comorbid personality disorders
- principal diagnosis other than depression
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 |
|---|---|---|
| EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patientsGroup CBT with a maximum number of 8 participants. Group is half-open allowing a starting date right after completion of acute ECT treatment. Patients participate for 15 sessions, which are framed by 2 individual sessions before joining the group and one individual session at treatment end. | Behavioural | Group CBT |
| Treatment as usualCan include continuation ECT, psychopharmacological treatment, individual psychotherapy | Other | Group CBT, Treatment as Usual |
Primary outcome
Clinican-Rated Depressive Symptoms at treatment end
Time frame: End of group therapy treatment (~6 months after ECT treatment)
MADRS
Clinican-Rated Depressive Symptoms at follow-up
Time frame: 6 months after end of group therapy
MADRS
4 secondary outcomes
Quality of life at follow-up
Time frame: 6 months after end of group therapy
Emotion regulation capacities at follow-up
Time frame: 6 months after end of group therapy
Self-Reported Depressive Symptoms at treatment end
Time frame: End of group therapy treatment (~6 months after ECT treatment)
Self-Reported Depressive Symptoms at follow up
Time frame: 6 months after end of group therapy
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 3 Aug 2021.
- Background: PubMed 24462229Brakemeier EL, Merkl A, Wilbertz G, Quante A, Regen F, Buhrsch N, van Hall F, Kischkel E, Danker-Hopfe H, Anghelescu I, Heuser I, Kathmann N, Bajbouj M. Cognitive-behavioral therapy as continuation treatment to sustain response after electroconvulsive therapy in depression: a randomized controlled trial. Biol Psychiatry. 2014 Aug 1;76(3):194-202. doi: 10.1016/j.biopsych.2013.11.030. Epub 2013 Dec 12.
- Individual participant dataSharing planned: No
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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.
Simone Grimm, Prof. Dr. principal investigator
Charite Universitaetsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients and Treatment as usual in people with Depression Chronic and Depression, Unipolar, run by Charite University, Berlin, Germany 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 1 inclusion and 2 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 3 Aug 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?
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?
Clinican-Rated Depressive Symptoms at treatment end (time frame: End of group therapy treatment (~6 months after ECT treatment)). The study lists 2 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 NCT04159285, which also lists 1 linked publication.
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 3 Aug 2021.