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临床试验/NCT06699719
NCT06699719已完成不适用

Feasibility, Efficacy, and Perceptions of an Online Writing Intervention in Patients With Major Depressive Disorder: A Multi-methods Study

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2019年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Feasibility of completing EW

研究概览

简要总结

The goal of this trial is to examine the feasibility of administering an online writing intervention to patients diagnosed with Major Depressive Disorder, and whether this intervention impacts symptoms of depression. It also examines the impact of the intervention on symptoms of anxiety, personal functioning, and perceived problem complexity, and how participants experience the intervention. The main questions the trial aims to answer are:

Will participants randomized to the online writing intervention complete at least three sessions? Is the writing intervention associated with a reduction in symptoms of depression and anxiety, perceived problem complexity, and/or an improvement in personal functioning? What are participants' perceptions of the online writing intervention, including both positive and negative experiences?

Participants will:

Complete four sessions of an online writing intervention or no writing intervention over the course of one week Complete questionnaires before and after the intervention, and at a one-month follow-up Complete qualitative interviews probing into their experiences with the intervention

详细描述

I. Introduction and Background

In a 2012 Statistics Canada Survey, 1.6 million Canadians reported that their needs for mental health services were unmet. In Ontario, almost 60% of mental health concerns are related to Major Depressive Disorder (MDD), representing an estimated excess of 210 million dollars in healthcare costs. Psychotherapy is an effective and enduring option for treating depression, but in Canada, its availability is limited. Increasing the number of psychotherapists does not seem to be an adequate solution to this issue; despite an increase in psychotherapy provision in the past decade, many Canadians are still in need of psychotherapy.

One solution is to develop innovative therapies that can be delivered reliably at low costs to large populations, for example, using the internet. Expressive writing (EW) is a simple intervention involving a series of journaling tasks where individuals write their deepest thoughts and feelings about a negative issue or problem. There is a large literature examining the various physical and psychological benefits associated with EW among different populations. EW appears to be a promising intervention for MDD. In one study of clinically depressed patients, EW completed in person for 20 minutes over three consecutive days resulted in less depressive symptoms relative to control writing, and this effect persisted after one month. Importantly, EW does not require manuals or highly trained clinicians, making it cost-effective and amenable to being administered remotely. Preliminary studies of its online administration with depressed individuals have produced encouraging findings.

II. Rationale and Study Objectives This study determines whether it is feasible to administer EW online to patients with MDD, and whether patients find it useful.

Feasibility concerns. Although the open-ended nature of EW makes it easy for patients to complete remotely (i.e., without the guidance or presence of a clinician), it presents a risk of drop-out particularly in severely depressed patients, due to a lack of motivation and other factors. The investigators assess the feasibility of administering EW remotely (i.e., online or by mail) to participants seeking treatment at CAMH for Major Depression. They also examine participants' perceptions of EW (i.e., its potential benefits and limitations), as well as their motivation and engagement with the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adults aged 18 or older
  • •assessed by a psychiatrist and received a diagnosis of MDD with or without another co-morbid condition
  • •access to the internet and an email address

排除标准

  • •no ability to understand, speak, or write in English

研究组 & 干预措施

Control

No Intervention

Participants are not asked to complete the online writing intervention

Expressive writing

Experimental

Participants are asked to complete four 20-minute sessions of an online writing task on consecutive days.

干预措施: Expressive writing (Behavioral)

结局指标

主要结局

Feasibility of completing EW

时间窗: Feasibility is determined immediately following the completion of the third writing session, which is at minimum after 3 days or one week, on average.

Feasibility is defined as 70% of EW participants completing at least three 20-minute sessions of EW.

Depressive symptoms

时间窗: On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups

Severity of depressive symptoms, as assessed via the Patient Health Questionnaire (PHQ-9); values range from 0-27 with higher scores indicating greater symptom severity (or worse outcome).

次要结局

  • Anxiety symptoms(On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups)
  • Impaired functioning(On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups)
  • Problem Complexity(On the next day after the fourth online writing session for participants assigned to EW or after one week for control participants, and at a one-month follow-up for both groups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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