Evaluation of the Effectiveness of a Newly Developed Blended Module for Patients Recovering From Depression (STAIRS): a Mixed Methods Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
研究概览
简要总结
Almost all mental healthcare treatments of depression focus on symptomatic recovery. However, such recovery does not inherently mean that personal recovery is reached. In fact, many persons still experience functional impairments after symptomatic recovery. As this has a negative influence on daily life, a new blended module (STAIRS) was developed to promote personal recovery in persons that are in the final stage of symptomatic recovery from depression. The current study will investigate the efficacy of STAIRS, by adding STAIRS to care as usual and comparing it with care as usual. It is hypothesized that STAIRS will have a positive effect on personal recovery and that this effect is larger than in the control group.
详细描述
The study uses a mixed methods design to determine efficacy and underlying mechanisms contributing to the effect of the STAIRS-training. One hundred forty adults, who are in the last phase of their depression treatment, will be enrolled and randomized (1:1) to (1) a group receiving the STAIRS-training next to Care as Usual (CAU) or (2) a group receiving CAU added with three information letters. Level of personal recovery, symptom severity, empowerment and control will be determined at baseline, at the end of the program (8 weeks) and at 6 months follow up. Approximately fifteen participants from the STAIRS group will be asked about their experiences with the different elements of the program and the perceived effects, in a semi-structured interview at the end of the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age 18 to 65 years old
- •Being in the last phase (recovery phase) of treatment for a diagnosed Major Depressive Disorder; psychological treatment is expected to end within three months or treatment is finished within the past 3 months and patient receives an aftercare and/or maintenance antidepressant treatment.
- •No more than moderate depression severity: Score of <38 on the Inventory of Depressive Symptomatology - Self Rated (IDS-SR).
- •The willingness to participate: an affirmative response to the question 'after being explained what participation means for you, are you willing to participate?'.
排除标准
- •Bipolar depression or depression with psychotic features.
- •Comorbid schizophrenia spectrum or other psychotic disorder.
- •Comorbid moderate or severe dependence of alcohol or drugs.
- •Neurological disorder (e.g., dementia).
- •Insufficient command of the Dutch language.
- •Cognitive problems or indication of low IQ (i.e.< 80).
- •Not in possession of a pc or smartphone.
- •Having been referred to a different mental health service for other mental problems
研究组 & 干预措施
Care As Usual plus STAIRS
Care as usual added with a eight week STAIRS-training
干预措施: Storytelling and Training to Advance Individual Recovery Skills (STAIRS) (Behavioral)
Care As Usual
Care as usual added with three information letters
结局指标
主要结局
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
时间窗: Baseline, end of treatment (8 weeks) and 6 months follow up
The I.ROC is a self report rating scale containing 12 items measuring the level of personal recovery. Each item is rated on a 6-point ordinal scale, ranging from 0 (never) to 5 (always). Total scores range from 0 to 72. A higher score is better.
Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score
时间窗: Baseline, end of treatment (8 week) and 6 months follow up
The RAS-DS is a self report rating scale containing 38 items measuring the level of personal recovery. Each item is rated on a 4-point ordinal scale, ranging from 0 (untrue) to 4 (completely true). Total scores range from 0 to 152. A higher score is better.
次要结局
- Depression relapse in the last six months, diagnosed with the Dutch version of the Mini International Neuropsychiatric Interview - Simplified (M.I.N.I - S), section MDEp(6 months follow up)
- Change from baseline in Netherlands Empowerment List (NEL) total score(Baseline, end of treatment (8 weeks) and 6 months follow up)
- Change from baseline in Mastery Scale total score(Baseline, end of treatment (8 weeks) and 6 months follow up)
- Change from baseline in Sheehan Disability Scale (SDS) total score(Baseline, end of treatment (8 week) and 6 months follow up)
- Change from baseline in Inventory of Depressive Symptomatology - Self Report (IDS-SR) total score(Baseline, end of treatment (8 weeks) and 6 months follow up)
- Change from baseline in Self-Management Ability Scale (SMAS-30) total score(Baseline, end of treatment (week 8) and 6 months follow up)
- Acceptability and usability of the STAIRS-training for patients recovering from a depression(End of intervention (8 weeks))
- Economic evaluation, based on the Treatment Inventory of Costs in Psychiatric patients(Baseline, end of treatment (8 weeks) and 6 months follow up)
- Perceived effects and program valuation by patients recovering from a depression(End of intervention (8 weeks))