Psychotherapeutic Augmentation of Brain Stimulation Effects

Not Applicable

Completed

• Conditions: Depression, Unipolar; Treatment Resistant Depression; Depression Chronic
• Interventions: Behavioral: EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients; Other: Treatment as usual

• Registration Number: NCT04159285
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-01-05
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-15
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• treated with ECT for major depression

Exclusion Criteria

• severe comorbid personality disorders
• principal diagnosis other than depression

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinican-Rated Depressive Symptoms at treatment end	End of group therapy treatment (~6 months after ECT treatment)	MADRS
Clinican-Rated Depressive Symptoms at follow-up	6 months after end of group therapy	MADRS

Secondary Outcome Measures

Name	Time	Method
Quality of life at follow-up	6 months after end of group therapy	WHOQL-Bref
Self-Reported Depressive Symptoms at follow up	6 months after end of group therapy	BDI
Self-Reported Depressive Symptoms at treatment end	End of group therapy treatment (~6 months after ECT treatment)	BDI
Emotion regulation capacities at follow-up	6 months after end of group therapy	Cognitive Emotion Regulation Questionnaire

Trial Locations

Locations (1)

Charité; 🇩🇪 Berlin, Germany