A Guided Internet-delivered Intervention for Adults With Residual Cognitive Symptoms After Major Depressive Disorder: Study Protocol for a Randomized Controlled Trial Investigating Clinical Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Behaviour Rating Inventory Of Executive Function-Adult
研究概览
简要总结
Background: Cognitive impairment and difficulties are frequently observed in individuals suffering from major depressive disorder. These impairments and difficulties can persist into remission as residual cognitive symptoms. Consequently affecting daily life functioning and quality of life for those affected. Few scalable interventions have targeted these symptoms and measured long-term clinical effects such as depression relapse.
详细描述
Background:Cognitive impairment and difficulties are frequently observed in individuals suffering from major depressive disorder. These impairments and difficulties can persist into remission as residual cognitive symptoms. Consequently affecting daily life functioning and quality of life for those affected. Few scalable interventions have targeted these symptoms and measured long-term clinical effects such as depression relapse.
Objectives: The aim is to assess the clinical effects of an intervention targeting residual cognitive symptoms after major depressive disorder. More specifically, if residual cognitive symptoms would be significantly decreased from pre- to post-treatment and remain stable at the 6-month and 2 year follow-up.
Methods: the study is a randomized, waitlist controlled trial including a total of 60 participants (30 in each arm). Primary measures are residual cognitive symptoms measured by the Behavioral Rating Inventory of Executive Functions Adults (BRIEF-A) and Perceived Deficit Questionnaire 5 (PDQ-5). Secondary outcome measures are Depression measured by Montgomery Aasberg Depression Rating Scale and Patient Health Questionnaire 9 and 2 (PHQ-9 and PHQ2), Satisfaction with life measured by Satisfaction with life scale (SWLS), Credibility measured by the Treatment Credibility and Expectation Scale, Rumination measured by the Rumination Response Scale (RRS), Depression screening assessed using the MINI International Psychiatric Interview, Usage data measured by number of log-ins, session length and days in treatment. Quantitative statistical methods will be used to analyze data.
Discussion: The results from the study will contribute to field of internet interventions and provide former depressed adults with an easy access intervention in the treatment of residual cognitive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The assessor do not allocate the participant to the intervention or waitlist group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously received treatment for major depressive disorder in primary or secondary healthcare services
- •Reporting a history of major depressive disorder symptoms assess using the MINI. few or minor depression symptomss (< 12 MADRS)
- •Not meeting criteria for major depressive disorder measured by the MINI)
- •Self-reporting residual cognitive symptoms that affects daily functioning (assessed by clinical psychologist)
- •No changes in anti-depressant medication under the study period
- •Age between 18 and 65 years
- •Read and write Norwegian
- •Internet and telephone access.
排除标准
- •Self-reported substance abuse
- •Neurological conditions or damage (e.g. autism, cerebral haemorrhage, and brain tumour)
- •Bipolar disorder
- •Psychosis.
结局指标
主要结局
Behaviour Rating Inventory Of Executive Function-Adult
时间窗: 2.5 years
The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A; Roth, Isquith, \& Gioia, 2005) is a 75-item self-report questionnaire designed to measure adults' behaviors associated with executive problems.
Perceived Deficit Questionnaire 5
时间窗: 2.5 years
Brief assessment of subjective cognitive difficulties and covers problems with concentration (e.g. "trouble concentrating on things like watching a television program or reading a book?"), memory (e.g. "forget what you talked about after a telephone conversation?"), and executive functioning (e.g. "have trouble getting things organized?"). Every item is rated on a scale of 0 (Never) to 4 (Almost always) to yield a sum score of 0 to 20, with higher scores indicating greater severity of cognitive symptoms.
次要结局
- The Satisfaction With Life Scale(2.5 years)
- Log-ins(8 months)
- Days in treatment(8 months)
- Rumination Response Scale(2.5 years)
- Patient Health Questionaire 9 and 2(2.5 years)
- The Credibility/Expectancy Questionnaire(8 months)
- Session length(8 months.)
- Montgomery Aasberg Depression Rating Scale(2.5 years)