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Идёт набор NCT05868135

Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment

Наблюдательное Depression Moderate Anxiety, Social Panic Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: eMeistring.
Кому может быть актуально
Состояния в реестре: Depression Moderate, Anxiety, Social, Panic Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Guided Internet-delivered Treatment for Moderate Depression, Social Anxiety Disorder and Panic Disorder - An Open Naturalistic Multicentre Cost-effectiveness Trial

Обзор

The goal of this observational multicentre study is to address the effectiveness and cost-effectiveness of providing a therapist guided internet based cognitive behavioural therapy (ICBT) for common mental disorders in a routine healthcare setting. Main research questions is 1) What is the effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics in routine care? 2) What is the cost-effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics? 3) Who benefits from guided internet-delivered treatment? 4) What are the predictors of drop-out from guided internet based treatment? 5) To what extent does user experiences of guided internet based treatment influence adherence and effectiveness? Participants will receive up to nine guided ICBT sessions (modules) and answer questionnaires covering symptoms severity, health related quality of life, work and social ability, user satisfaction and medication. All questionnaires are part of the standard patient follow up routines in the four treatment locations participating in the study. Analytical approach is to compare locations/clinics and subgroups of patients.

Подробное описание

The therapist guided internet based cognitive therapy (ICBT) cover moderate depression, social anxiety disorder (SAC) and panic disorder (PD).

The eMeistring-program is standard treatment in all four hospitals/locations participating in the study. Patients are recruited through the ordinary clinical patient pathways. After a pre-treatment assessment, an initial face-to-face visit takes place (T1). Patients are given the opportunity to participate in the study based on informed concent. Next, participants in the depression program will receive eight guided internet based cognitive behavioural therapy sessions or modules. Similarly SAC and PD patients will receive nine modules. Therapist guidance are provided at least once a week via a secure email system. When sessions are finished (T2), a new face-to-face visit with the therapist is offered.

Therapists are licensed health personnel e.g. psychologists, registered nurses and clinical social workers, working in the clinics.

Administrative data about covering organizational implementation of the eMeistring treatment program, personnel involved and level of treatment activity is collected separately.

Inclusion criteria's for eMeistring therapy: having moderate depression, panic disorder and social anxiety disorder as a primary disorder, and having computer and internet access.

Exclusion criteria: severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month), severe reading or writing disabilities.

Adverse events are taken care of through routine follow-up according to the outpatient clinic responsibility. Any responses from patients indicating suicidal behaviour triggers email to the therapist with an urge to follow-up.

Planned statistical analyses include multivariate analyses of effectiveness (intention-to-treat and completers), predictor analyses of drop-out and adherence, and cost-effectiveness analyses based on health related quality of life, intervention costs and other health care and societal costs, analysing location specific differences stratified by patient groups.

Вмешательства

  • Поведенческое eMeistring
    Initial face-to-face visit, eight/nine sessions/modules of therapist guided ICBT, final face-to-face visit

Первичные конечные точки

  • Depression severity [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • Social phobia [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • Panic disorder symptoms [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
Вторичные конечные точки (9)
  • Health Related Quality of Life [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • Work and social adjustment [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • Anxiety severity [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • System Usability [Срок оценки: Up to 14 weeks after treatment start (T2)]
  • Depression severity [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • Cost of health care services [Срок оценки: Period between pre treatment (T1) and up to 14 weeks after treatment start (T2), and to six months after post treatment (T3) and until two years (T4)]
  • Medication [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after T2 (T3) and after two years (T4)]
  • Work participation [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)]
  • Sickness absenteeism [Срок оценки: Pre treatment (T1), up to 14 weeks after treatment start (T2), six months after post treatment (T3) and after two years (T4)]

Критерии участия

Критерии включения

Having moderate depression, panic disorder and social anxiety disorder as a primary disorder. Access to computer and internet.

Критерии исключения

Having severe depression, suicidal impulses and thoughts, bipolar disorders, psychosis, substance abuse, unstable medication last month, severe reading or writing disabilities.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Норвегия · 4 центра
  • Helse Bergen HF — Bergen
  • Sykehuset Innlandet HF — Lillehammer
  • St. Olavs Hospital HF — Trondheim
  • Sykehuset i Vestfold HF — Tønsberg

Идентификаторы

NCT: NCT05868135 · 229387

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗