Clinical trial NCT04159285: Psychotherapeutic Augmentation of Brain Stimulation Effects
Official title: Augmenting and Sustaining Electroconvulsive Therapy (ECT) Treatment Effects by Group Cognitive Behavioural Therapy (CBT) in Unipolar Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Chronic
Depression, Unipolar
Treatment Resistant Depression
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* treated with ECT for major depression

Exclusion Criteria:

* severe comorbid personality disorders
* principal diagnosis other than depression

Primary outcomes:
measure: Clinican-Rated Depressive Symptoms at treatment end
timeFrame: End of group therapy treatment (~6 months after ECT treatment)
measure: Clinican-Rated Depressive Symptoms at follow-up
timeFrame: 6 months after end of group therapy
Secondary outcomes:
measure: Quality of life at follow-up
timeFrame: 6 months after end of group therapy
measure: Emotion regulation capacities at follow-up
timeFrame: 6 months after end of group therapy
measure: Self-Reported Depressive Symptoms at treatment end
timeFrame: End of group therapy treatment (~6 months after ECT treatment)
measure: Self-Reported Depressive Symptoms at follow up
timeFrame: 6 months after end of group therapy
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charite Universitaetsmedizin
name: Simone Grimm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.