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NCT Number: NCT04159285

Psychotherapeutic Augmentation of Brain Stimulation Effects

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

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Key information

Conditions

Depression Chronic Depression, Unipolar Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Treatment Resistant Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • treated with ECT for major depression

Exclusion criteria

  • severe comorbid personality disorders
  • principal diagnosis other than depression

Treatment and study plan

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

Behavioral

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.

Treatment as Usual

Other

Can include continuation ECT, psychopharmacological treatment, individual psychotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Augmenting and Sustaining Electroconvulsive Therapy (ECT) Treatment Effects by Group Cognitive Behavioural Therapy (CBT) in Unipolar Depressed Patients

Acronym: PAUSE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2019
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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