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Psychotherapeutic Augmentation of Brain Stimulation Effects (PAUSE)

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ClinicalTrials.gov Identifier: NCT04159285
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Simone Grimm, Charite University, Berlin, Germany

Brief 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. 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

Condition or disease Intervention/treatment Phase
Depression Chronic Depression, Unipolar Treatment Resistant Depression Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients Other: Treatment as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Augmenting and Sustaining Electroconvulsive Therapy (ECT) Treatment Effects by Group Cognitive Behavioural Therapy (CBT) in Unipolar Depressed Patients
Actual Study Start Date : January 5, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group CBT
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.
Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients
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.

Other: Treatment as usual
Can include continuation ECT, psychopharmacological treatment, individual psychotherapy

Experimental: Treatment as Usual
Patients may receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication.
Other: Treatment as usual
Can include continuation ECT, psychopharmacological treatment, individual psychotherapy




Primary Outcome Measures :
  1. Clinican-Rated Depressive Symptoms at treatment end [ Time Frame: End of group therapy treatment (~6 months after ECT treatment) ]
    MADRS

  2. Clinican-Rated Depressive Symptoms at follow-up [ Time Frame: 6 months after end of group therapy ]
    MADRS


Secondary Outcome Measures :
  1. Quality of life at follow-up [ Time Frame: 6 months after end of group therapy ]
    WHOQL-Bref

  2. Emotion regulation capacities at follow-up [ Time Frame: 6 months after end of group therapy ]
    Cognitive Emotion Regulation Questionnaire

  3. Self-Reported Depressive Symptoms at treatment end [ Time Frame: End of group therapy treatment (~6 months after ECT treatment) ]
    BDI

  4. Self-Reported Depressive Symptoms at follow up [ Time Frame: 6 months after end of group therapy ]
    BDI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treated with ECT for major depression

Exclusion Criteria:

  • severe comorbid personality disorders
  • principal diagnosis other than depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159285


Contacts
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Contact: Corinna Hartling 0049 30 450 517 645 corinna.hartling@charite.de

Locations
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Germany
Charité Recruiting
Berlin, Germany, 12203
Contact: Simone Grimm, PhD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Simone Grimm, Prof. Dr. Charite Universitaetsmedizin
Publications:
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Responsible Party: Simone Grimm, Prof. Dr.rer.nat. Simone Grimm, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04159285    
Other Study ID Numbers: PAUSE
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders