Psychotherapeutic Augmentation of Brain Stimulation Effects (PAUSE)

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Charité University Medicine Berlin

Status

Completed

Conditions

Treatment Resistant Depression
Depression, Unipolar
Depression Chronic

Treatments

Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients
Other: Treatment as usual

Study type

Interventional

Funder types

Other

Identifiers

NCT04159285
PAUSE

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

treated with ECT for major depression

Exclusion criteria

  • severe comorbid personality disorders
  • principal diagnosis other than depression

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Group CBT
Experimental group
Description:
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.
Treatment:
Other: Treatment as usual
Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients
Treatment as Usual
Experimental group
Description:
Patients may receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication.
Treatment:
Other: Treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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