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Una comparación de dos intervenciones ultrabreves en atención primaria para pacientes con ansiedad, depresión y estrés. (RNTACTSweden)

18 de septiembre de 2026 actualizado por: Region Skane

A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Pilot Randomized Controlled Trial.

This pilot randomized controlled trial evaluated the feasibility of a Swedish translation of an Acceptance and Commitment Therapy protocol targeting repetitive negative thinking (RNT-ACT) compared with therapist-supported internet-based cognitive behavioral therapy (iCBT) in Swedish primary care. Feasibility was assessed in terms of recruitment, intervention completion, and patient satisfaction. Symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion were assessed as secondary outcomes.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This pilot randomized controlled trial was conducted to evaluate the feasibility of RNT-ACT in Swedish primary care, using therapist-supported iCBT as an active comparator. Participants were randomized to either RNT-ACT or iCBT.

RNT-ACT consisted of two 60-minute therapy sessions and audio exercises for participants to use between sessions. Participants allocated to iCBT received an internet-based cognitive behavioral therapy program for anxiety or depression, delivered through the secure Stöd och Behandling platform used in Region Skåne, with therapist support available through the platform.

The primary feasibility outcomes were recruitment rate, intervention non-completion, and patient satisfaction measured with the Client Satisfaction Questionnaire (CSQ-8). Secondary outcomes included symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion. Secondary outcomes were included to describe the sample and patterns of change and were not intended to provide evidence of comparative treatment efficacy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

13

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Skåne County
      • Helsingborg, Skåne County, Suecia, 254 83
        • Vårdcentralen Laröd

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • DASS-21 total score >20
  • Ability to communicate in spoken and written Swedish

Exclusion Criteria:

  • Physical illness requiring further medical assessment identified during routine screening
  • Ongoing psychological or psychiatric treatment
  • A level of suicide risk considered clinically incompatible with study participation
  • Substance abuse
  • Anorexia nervosa
  • Psychotic disorder
  • Bipolar disorder
  • Attention-deficit/hyperactivity disorder (ADHD)
  • Antisocial personality disorder
  • A level of exhaustion considered incompatible with study participation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: RNT-ACT protocol

Participants randomized to RNT-ACT will receive a total of 2 sessions of 60 minutes each as well as audio files to listen to between the occasions administered via internet. Previous studies have indicated that it doesn't make much of a difference whether the temporal distance between session 1 and session 2 is between 1 week and up to 3 months. At occasion 1, the time for occasion 2 is set. The temporal distance in days will noted for each patient. The treatment is inserted into the therapist's regular diary with 60 minutes session time and appropriate break before and after the treatment (e.g. at least 5-10 minutes) for preparation and post-administration where journal writing is included.

Swedish Translation of the 2*60 minute Acceptance and Commitment Protocol for Repetitive Negative Thinking.

Otros nombres:
  • Terapia de Aceptación y Compromiso (ACT)
Comparador activo: iCBT treatment

The people randomized to Internet treatment will be offered based on M.I.N.I 7.0 a suitable iCBT program in the Stöd och Behandling (SoB) platform. The patients follow a structured self-help material which can be seen as a standard treatment option in Region Skåne, "treatment as usual". The therapist has access to the material and the patient and the therapist can communicate via a chat function. The patients are matched to iCBT programs based on whether they are most likely to show symptoms of depression or anxiety. The main component of Internet processing consists of a structured self-help program in approximately eight modules, somewhat varying depending on which program in use. The program is based on proven CBT interventions for each problem area with a strong emphasis on psychoeducation but where different intervention elements is included.

Therapist-supported internet-based Cognitive Behavioral Therapy (iCBT), provided as part of routine care in Swedish primary care and used as the active comparator.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment rate
Periodo de tiempo: At screening and enrolment.

Percentage of participants enrolled among all individuals screened for participation. Calculated as the number of participants enrolled divided by the total number of individuals screened, multiplied by 100.

At screening and enrolment.
Intervention non-completion rate
Periodo de tiempo: From randomization through completion of the allocated intervention, up to approximately 3 months.

Percentage of randomized participants who did not complete their allocated intervention. Intervention completion was assessed as a binary outcome.

From randomization through completion of the allocated intervention, up to approximately 3 months.
CSQ-8
Periodo de tiempo: At the main post-treatment follow-up; if not completed, at the 3-month follow-up.

Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.

At the main post-treatment follow-up; if not completed, at the 3-month follow-up.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
DASS-21
Periodo de tiempo: At baseline, main post-treatment follow-up, and 3-month follow-up.

Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63, with higher values indicating greater psychological distress.

At baseline, main post-treatment follow-up, and 3-month follow-up.
RRS-BR
Periodo de tiempo: At baseline, main post-treatment follow-up, and 3-month follow-up.

Ruminative Responses Scale - Brooding and Reflection (RRS-BR). Total score range 10-40, with higher values indicating a greater tendency to ruminate.

At baseline, main post-treatment follow-up, and 3-month follow-up.
SAAQ
Periodo de tiempo: At baseline, main post-treatment follow-up, and 3-month follow-up.

Swedish Acceptance and Action Questionnaire (SAAQ). Total score range 6-42, with higher values indicating greater psychological inflexibility.

At baseline, main post-treatment follow-up, and 3-month follow-up.
Valuing Questionnaire (VQ)
Periodo de tiempo: At baseline, main post-treatment follow-up, and 3-month follow-up.

Valuing Questionnaire (VQ). A 10-item self-report measure of valued living comprising two subscales, Progress and Obstruction, five items each. Each subscale has a score range of 5-35. Higher Progress scores and lower Obstruction scores indicate greater valued living. Each item is rated on a seven-point Likert-type scale ranging from 1 (Not at all true) to 7 (Completely true).

At baseline, main post-treatment follow-up, and 3-month follow-up.
CFQ-7
Periodo de tiempo: At baseline, main post-treatment follow-up, and 3-month follow-up.

Cognitive Fusion Questionnaire - 7 items (CFQ-7). Total score range 7-49, with higher values indicating greater cognitive fusion.

At baseline, main post-treatment follow-up, and 3-month follow-up.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Veronica Milos Nymberg, PhD, Lund University/Region Skåne

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de febrero de 2024

Finalización primaria (Actual)

20 de diciembre de 2024

Finalización del estudio (Actual)

25 de mayo de 2025

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2023

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2023

Publicado por primera vez (Actual)

14 de julio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2022-06465-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .