Digital IAPT: The Effectiveness & Cost-effectiveness of Internet-delivered Interventions for Depression and Anxiety Disorders in the Improving Access to Psychological Therapies Programme
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change in Depression symptoms
研究概览
简要总结
Depression and anxiety are common mental health problems. There are effective treatments for depression and anxiety and one of these is talking therapies using cognitive behaviour therapy (CBT). In recent years CBT has been transferred to online delivery methods and these interventions have proven successful for people being treated with symptoms of depression and anxiety.
The current study will utilise a randomised controlled trial design, where the majority (n=240) of participants will be allocated to the immediate treatment (internet-delivered CBT for either depression or anxiety), and a smaller number (n=120) will be allocated to a waiting list. The waiting list group will receive treatment after an eight week wait. This design helps us to understand that any changes in symptoms in the treatment group will be likely due to the treatment they received compared to the waiting list.
A sample size of 360 participants is proposed and has been adjusted to ameliorate against patient dropout. Follow-up and maintenance of any positive changes in symptoms is very important in CBT for depression and anxiety, simply because some people can have a relapse of symptoms. We will therefore follow-up the treatment group for 3, 6, 9 and 12 months to assess maintenance of positive gains from treatment.
The study also seeks to investigate the cost effectiveness of the treatments.
详细描述
A CONSORT compliant single-blinded, parallel-groups, randomised controlled trial design will be used to examine the efficacy of internet-delivered interventions for depression and anxiety disorders against a waiting list control group. To be eligible participants will be screened and will need to score ≥ 9 on the PHQ-9 and / or ≥ 8 on the GAD-7. To establish a formal diagnosis of depression or anxiety, eligible participants will complete the M.I.N.I. neuropsychiatric interview and thereafter will be randomised to either an immediate treatment group or a waiting list group. Randomisation will follow a 2:1 ratio. The immediate treatment will complete a M.I.N.I. neuropsychiatric interview at 3-months follow-up from baseline. The treatment group will be followed up at 6-, 9- and 12-months post-treatment. The waiting list control group will be enrolled into the treatment once the immediate treatment group will have completed. The waiting list will complete baseline screening and research measures at baseline and similarly complete research measures at the end of the waiting period (8-weeks).
In addition, a nested study examining the mediators and moderators for change and maintenance of change is included. Specific and general mechanisms of change will be explored to include positive beliefs about repetitive negative thinking, therapeutic skills usage and therapist behaviours. General mediators including the therapeutic alliance and participant's expectancy / credibility and will be examined. The study protocol, information on the study, informed consent will be submitted for approval by the NHS England Research Ethics Committee and Health Research Authority approval for the study will be sought.
The study aims to evaluate the effectiveness and cost effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT.
Individuals who contact Berkshire Healthcare NHS Foundation Trust to access IAPT psychological services will be eligible to participate. Recruitment will begin in May 2017 and will continue for 6 months until the numbers are reached or exceeded.
Using G-Power to calculate our sample size and based on a moderate between group effect size of d=0.5 with a power of 80% and a 2:1 randomisation procedure into immediate treatment for depression and/or anxiety and a corresponding waiting list control group returned a total sample of 288. Adding a 25% uplift to ameliorate against attrition gave a total sample size of 360. Therefore for depression a total sample of 120 in the treatment group and a corresponding 60 in the control group and the same ratio for anxiety disorders. The 2:1 randomisation procedure was implemented to reduce the concern of having many people waiting for treatment after presenting to the IAPT service.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A score of ≥ 9 on PHQ-9 and/ or a score of ≥ 8 on GAD-7
- •18 years of age
- •Suitable for an internet-delivered intervention (iCBT)
排除标准
- •Suicidal intent/ideation
- •Psychotic illness
- •Currently in psychological treatment for depression and/or anxiety
- •Alcohol or drug misuse
- •Previous diagnosis of an organic mental health disorder
研究组 & 干预措施
iCBT for Depression and Anxiety
SilverCloud Internet-Delivered Cognitive Behavioural Therapy
干预措施: SilverCloud Internet-delivered Cognitive Behavioural Therapy (Behavioral)
Waiting List
Waiting list control
干预措施: Waiting List (Other)
结局指标
主要结局
Change in Depression symptoms
时间窗: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Measured by the 9 item Patient Health Questionnaire (PHQ-9)
Change in Anxiety symptoms
时间窗: Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up
Measured by the 7 item Generalised Anxiety Disorder inventory (GAD-7)
次要结局
- Work and Social Adjustment(Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Quality of life(baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Rumination(Baseline and 8 weeks)
- Social Anxiety(Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Generalised Anxiety Symptoms(Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Client service usage(baseline, 8 weeks, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Therapeutic Expectancy(Baseline, 4 weeks and 8 weeks.)
- Emotion Regulation(Baseline and 8 weeks)
- CBT Skills Usage(3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Therapeutic Alliance for clinicians(During the patient recruitment period.)
- M.I.N.I. International Neuropsychiatric Interview(Baseline and 3-month follow-up)
- Patient Experience/Satisfaction(Post treatment (up to 8 weeks).)
- Health Anxiety(Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Panic(Baseline, at treatment review sessions (maximum of 6 across an 8 week treatment period), 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Therapist Behaviours(Continuous during treatment after each session for 8 weeks)
- Quality of life for users of mental health services(baseline, 8 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up and 12 month follow-up)
- Therapeutic Alliance for patients(Continuous during treatment after each session for 8 weeks)