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PCT after rTMS for relapse prevention of depression

PCT after rTMS for relapse prevention of depression - rTMS-PCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56852
Enrollment
20
Registered
2023-11-10
Start date
2024-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDD

Interventions

PCT may prolong the effect of rTMS leading to a quick and long term effective&nbsp
treatment method for chronically ill patients with high health care costs.&nbsp
Combining these two forms of evidence based treatment for MDD may lead to lower&nbsp
relapse rates and costs reduction. In this trial, half of the randomized&nbsp
patients will receive PCT online via video call and half will receive PCT F2F&nbsp
to study the feasibility of the add-on treatment for patients receiving rTMS.&nbsp
All patients who receive rTMS treatment are psychotherapeutically treated&nbsp
during rTMS treatment period as stated in the depression guideline. After&nbsp
informed consent, patients are included in the current pilot study when&nbsp
responding to rTMS and reaching at least 25-50% reduction of symptoms or remission&nbsp
(scores 14-22 for partial responders and &lt
14 for responders) on the IDS self-report scale (Inventory of Depressive&nbsp
Symptoms). Patients not responding will continue to receive regular&nbsp
psychotherapy and will not be included in the current pilot study. PCT consists&nbsp
of 8 weekly sessions of individual psychotherapy according to the protocol and&nbsp
will be performed by a qualified Health care psychologist. PCT sessions via&nbsp
videocall proved to be feasible in a former study by Brouwer et al. (2020) and&nbsp
our study population may be supraregional due to the fact that rTMS treatment&nbsp
is not widely offered in patient care. A short-form questionnaire (experience&nbsp
sampling methodology) will be used to monitor daily positive and negative&nbsp

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Patients are (partially) responding or in remission directly after rTMS • Have a IDS-SR scale between 14-22 for partial responders or <14 for responders or at least 25-50% reduction of complaints for partial responders or at least 50% reduction of complaints for responders • Are aged 18 years or older • Speak Dutch

Exclusion criteria

Exclusion criteria: Not applicable.

Design outcomes

Primary

MeasureTime frame
Treatment adherence (number of sessions, number of weeks in which treatment is given, outcome rating scale of each PCT session, adherence to homework assignments and possible relapse/duration of remission, personal preference for treatment method for each patient) will be used as primary descriptive outcome measures and gathered using registration of therapists and EPIC. Number of weeks of remission will be monitored using the IDS-SR (Rush et al. 1996) and Hamilton Depression Rating Scale (HDRS) (Hamilton, M. 1980). Both questionnaires are used for registering depressive symptoms and response rates in rTMS (treatment as usual) and will be administered directly after completing PCT, after 3 months and after 6 months post baseline.

Secondary

MeasureTime frame
The secondary outcome parameter of the study is affect fluctuations as measured with daily short-form questionnaires during PCT treatment. Patients fill in their affective state and the mean affect score that is derived from the questionnaires will be used as secondary outcome measures.

Countries

Netherlands

Contacts

Public ContactL Aben

Amsterdam UMC

rtms-pctstudie@amsterdamumc.nl06 50 01 86 03

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026