NCT04159285

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 1, 2019

Last Update Submit

August 2, 2021

Conditions

Depression ChronicDepression, UnipolarTreatment Resistant Depression

Outcome Measures

Primary Outcomes (2)

  • Clinican-Rated Depressive Symptoms at treatment end

    MADRS

    End of group therapy treatment (~6 months after ECT treatment)

  • Clinican-Rated Depressive Symptoms at follow-up

    MADRS

    6 months after end of group therapy

Secondary Outcomes (4)

  • Quality of life at follow-up

    6 months after end of group therapy

  • Emotion regulation capacities at follow-up

    6 months after end of group therapy

  • Self-Reported Depressive Symptoms at treatment end

    End of group therapy treatment (~6 months after ECT treatment)

  • Self-Reported Depressive Symptoms at follow up

    6 months after end of group therapy

Study Arms (2)

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.

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

Treatment as Usual

EXPERIMENTAL

Patients may receive continuation ECT and/or individual psychotherapy and/or take anti-depressive medication.

Other: Treatment as usual

Interventions

EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patientsBEHAVIORAL

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.

Group CBT
Treatment as usualOTHER

Can include continuation ECT, psychopharmacological treatment, individual psychotherapy

Group CBTTreatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • treated with ECT for major depression

You may not qualify if:

  • severe comorbid personality disorders
  • principal diagnosis other than depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, 12203, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24462229BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, Treatment-Resistant

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Simone Grimm, Prof. Dr.

    Charite Universitaetsmedizin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.rer.nat. Simone Grimm

Study Record Dates

First Submitted

August 1, 2019

First Posted

November 12, 2019

Study Start

January 5, 2019

Primary Completion

May 1, 2021

Study Completion

June 15, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)