Replication: Meaning-centered Intervention for Internalizing Symptoms

Официальное название

Testing the Efficacy of a Meaning-centered Intervention for Individuals Who Tend to Feel Down or Anxious: a Replication

Обзор

Young adults who experience depression and/or anxiety symptoms (i.e., internalizing symptoms) will be randomly allocated to a six-session meaning-centered intervention condition or a waitlist condition. Both conditions receive the same questionnaires at baseline, post assessment (intervention condition: immediately after the final session; waitlist: four weeks after baseline), and follow-up. The researchers hypothesize that a meaning-centered intervention for individuals with internalizing symptoms will increase participants' meaning in life and reduce their internalizing symptoms at post assessment and 4-week follow-up when compared to a waitlist condition.

Подробное описание

First-year psychology students at the University of Groningen will be screened for depression and anxiety symptoms. Those with heightened symptoms will be invited via e-mail to participate in the study. After filling out the baseline assessment online, participants will be randomly assigned to either a meaning-centered intervention condition, which will receive a meaning-centered intervention taking place approximately every four days, or a waitlist condition, which will be assigned no task. Participants in the intervention condition will follow six 1-hour online intervention sessions led by a trainer and conduct intervention-related homework assignments. The sessions can be followed in English, Dutch, or German. The intervention aims to increase participants' meaning in life and reduce their internalizing symptoms. Immediately after the final session (i.e. approximately one month after the baseline assessment), participants in the intervention condition will be asked to fill in the post assessment, which includes the same questionnaires as the baseline assessment. Additionally, they will be ask to provide feedback about the intervention regarding session and homework content. Participants in the waitlist control will be asked to complete the post assessment one month after their baseline assessment. One month after the post assessment, participants in both conditions are asked to fill in same set of questionnaires. Waitlist participants are offered to receive the intervention sessions after the study has finished. Participants are compensated with SONA credits. This study will replicate a previous study initially testing the meaning-centered intervention (https://clinicaltrials.gov/study/NCT07058181?aggFilters=status:,phase:\&tab=researcher#trial-description).

Вмешательства

• Поведенческое Meaning-centered intervention for individuals who tend to feel down or anxious
  * Six 1-hour individual online sessions, approximately every 4 days * Sessions led by a certified trainer based on intervention manual * Four sources of meaning will be explored: personal life story, dealing with life's limitations, creating one's own life, and meaningful experiences * Participants follow intervention using intervention the workbook * Homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives

Первичные конечные точки

• Depression Anxiety Stress Scale (DASS-21) [Срок оценки: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)]
• Meaning in Life Questionnaire (MLQ) [Срок оценки: Time Frame: at baseline; post (one month after baseline); one-month follow-up (one month after post)]

Критерии участия

Критерии включения

• heightened internalizing symptoms (depression and/or anxiety symptoms) as indicated by PHQ-4 score of 2 or above on either the anxiety or depression subscale

Критерии исключения

• receiving psychotherapeutic treatment for a depressive or anxiety disorder
• suicidality

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07714954 · PSY-2526-S-0246

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗