The Effects on Depression of Internet-administered Behavioural Activation and Physical Exercise With Treatment Rationale and Relapse Prevention: Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Change from baseline in Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The purpose of this study is to compare an internet-based behavioral activation program with a physical activation program, as treatments for mild to moderate depression. The added effect of rationale and motivational interviewing will also be studied, as well as the effects of relapse prevention program.
详细描述
BACKGROUND:
Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.
METHODS/DESIGN:
This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.
DISCUSSION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Satisfy DSM-IV (or DSM-V) criteria for depression, with depression being primary diagnosis
- •Scoring within the interval 15-35 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- •Living in Sweden and being able to read Swedish
- •Access to computer with internet connection
排除标准
- •Currently receiving other psychological treatment
- •Non-stable use of psychoactive medication
- •Deemed to suffer from a too severe depression
- •Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
研究组 & 干预措施
1a
In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)
干预措施: Physical activity without motivational interviewing (Behavioral)
1b
In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)
干预措施: Physical activity without motivational interviewing (Behavioral)
2a
In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)
干预措施: Physical exercise with motivational interviewing (Behavioral)
2b
In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)
干预措施: Physical exercise with motivational interviewing (Behavioral)
3a
In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)
干预措施: Behavioral activation with rationale (Behavioral)
3b
In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)
干预措施: Behavioral activation with rationale (Behavioral)
4a
In phase 1, group 4 undergoes behavioral activation without added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)
干预措施: Behavioral activation without rationale (Behavioral)
4b
In phase 1, group 4 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)
干预措施: Behavioral activation without rationale (Behavioral)
Phase 1 Waiting list control group
Control group during phase 1, in parallel with treatment groups 1-4. Weekly self-report measurements, the results of which are conveyed in the form of individualized feedback. After 12 weeks, the participants of the control group (n = 100) are randomized to one four phase 1 active treatment groups (1-4) and receive treatment accordingly.
结局指标
主要结局
Change from baseline in Patient Health Questionnaire (PHQ-9)
时间窗: Monthly, 0-24 months
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Change from baseline in Patient Health Questionnaire (PHQ-9)
时间窗: Weekly during treatment period of 12 weeks
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Change from baseline in Patient Health Questionnaire (PHQ-9)
时间窗: 24 hours
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Change from baseline in Patient Health Questionnaire (PHQ-9)
时间窗: 12 months
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Change from baseline in Patient Health Questionnaire (PHQ-9)
时间窗: 24 months
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
次要结局
- Change from baseline in the International Physical Activity Questionnaire (IPAQ)(24 months)
- Change from baseline in Quality Of Life Inventory (QOLI)(24 months)
- Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)(Monthly, 0-24 months)
- Change from baseline in MINI(Monthly, 0-24 months)
- Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)(24 hours)
- Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)(12 months)
- Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)(24 months)
- Change from baseline in the International Physical Activity Questionnaire (IPAQ)(24 hours)
- Change from baseline in the International Physical Activity Questionnaire (IPAQ)(12 months)
- Change from baseline in Quality Of Life Inventory (QOLI)(24 hours)
- Change from baseline in Quality Of Life Inventory (QOLI)(12 months)
研究者
Per Carlbring, PhD
Professor
Umeå University