Evaluating an Ultra-Brief Intervention for The Treatment Of COVID-19 Related Anxiety in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- The number of participants screened positive for anxiety by the GAD-7 who are eligible for the study.
研究概览
简要总结
Anxiety Disorders or Depressive Disorders with anxiety, affect about 3/5 pregnancies. It is known that if left untreated, these disorders are associated with poor delivery outcomes, ongoing mental illness, and negative effects on the child. The COVID-19 pandemic has created heightened anxiety in many people especially the most vulnerable. As a result, the investigators have seen that pregnant women report even higher rates of anxiety than in the past. Talk therapy is recommended but is underused in part because it takes a long time to learn and use. The COVID crisis has added another layer of complexity in that in-person treatment is not routinely available. The investigator team has adapted a talk therapy treatment, "Mindful adaptive practice in pregnancy (MAPP)" where women are taught skills to reduce anxiety. This treatment is done virtually over the internet in a synchronous group format. The overall objective of this study is to assess the feasibility, acceptability, and adherence to the clinical trial protocol evaluating MAPP on anxiety symptoms among pregnant women. This synchronous virtual treatment is novel and has the potential to change clinical practice as it will effectively reduce anxiety, takes a short time to learn and women will have access to it regardless of living in rural or remote areas. The results of this study will guide the development of a larger multi-site randomized controlled trial (RCT).
详细描述
Antenatal mental illness is common. About 3/5 of women have antenatal anxiety or depression with anxiety which are both linked to adverse delivery outcomes and negative effects on child development. Often these conditions remain undetected/untreated, perpetuating the cycle of mental illness. A Canadian survey of pregnant women (~2000, April 2020) found >50% endorsed anxiety and > 2/3 elevated anxiety specific to pregnancy during the COVID-19 pandemic. This is on a background of elevated rates of antenatal mental illness. Psychotherapeutic interventions are preferred antenatally but barriers prevent their initiation and adherence (i.e., time duration). With the pandemic and the spike in anxiety, these vulnerable women are at risk to continue being ill and their child at risk for negative delivery/ longer-term outcomes. It is imperative these women receive rapid treatment to reduce acute anxiety to prevent mental health deterioration and the potential adverse effects. The pandemic has also forced clinicians to deliver healthcare in creative ways such as providing psychiatric care virtually despite their not knowing if the therapy can be effectively provided in this way and must be evaluated.
Mindful Adaptive Practice in Pregnancy (MAPP) is a novel ultra-brief psychotherapy developed by the investigator team to reduce anxiety. Prior work (nonclinical samples) suggested high recruitment and retention, significant distress reduction, and enhancement of wellbeing at rates comparable to gold standard therapies of longer duration. The work with clinical samples has shown it to have a large effect size. The investigators have adapted the technique to pregnant women to address the urgent clinical need for a brief, effective targeted intervention. As the investigators were challenged to offer health care services creatively, they adapted MAPP for virtual delivery, in a group format using the Ontario Telemedicine Network for example.
The overall objective of this study is to determine the feasibility, acceptability, and adherence to a clinical trial protocol evaluating the MAPP intervention on anxiety symptoms among pregnant women. The results of this pilot work will guide the development of a larger multi-site randomized controlled trial (RCT) to definitively evaluate the effectiveness of MAPP. As a secondary outcome, the investigators will assess the effect of MAPP in reducing anxious symptoms; this preliminary data on MAPP's effect will inform an effect size for the larger trial power analysis.
Pregnant participants from obstetrics, family practice, midwifery, and reproductive psychiatry clinics, as well as self-referral from social media, will be recruited. Sixty women will be randomized to the control group (standard care) or the intervention group (standard care plus MAPP). Outcomes will be captured electronically right after therapy ends, 3 months post-therapy, and 6 months post-therapy. Results of this work will be used for the larger trial which will have the potential to change clinical practice. Subsequent knowledge translation activities will foster knowledge uptake of the pilot results and once the final RCT is completed, the intervention will be widely disseminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •At 12-30weeks gestation
- •Score > 7 on the GAD-7
- •Have internet access with camera, microphone, and ability to run the necessary software.
- •Fluent in written and spoken English
- •Willing to provide the name and contact details of their primary health care provider / other contact who would know person's whereabouts.
排除标准
- •Current substance use
- •Current psychotic/manic symptoms
- •Active suicidal ideation
- •Current use of psychotropic medication with dose change within 4 weeks of recruitment
- •Currently receiving psychotherapy
- •Unwilling to be randomized.
研究组 & 干预措施
Mindful Adaptive Practice in Pregnancy Therapy
Participants allocated to the intervention group will have access to treatment as usual in addition to synchronous virtual MAPP.
MAPP draws upon existing integrative principles of structured psychotherapies (mindfulness-based, cognitive, behavioural and relational psychotherapy)
干预措施: Mindful Adaptive Practice in Pregnancy Therapy (Other)
Mindful Adaptive Practice in Pregnancy Therapy
Participants allocated to the intervention group will have access to treatment as usual in addition to synchronous virtual MAPP.
MAPP draws upon existing integrative principles of structured psychotherapies (mindfulness-based, cognitive, behavioural and relational psychotherapy)
干预措施: Treatment as usual (TAU) (Other)
Treatment as usual
All participants allocated to the control group will have access to standard care.
干预措施: Treatment as usual (TAU) (Other)
结局指标
主要结局
The number of participants screened positive for anxiety by the GAD-7 who are eligible for the study.
时间窗: 11 months
Among pregnant women who screen positive for anxiety, what is the rate of eligibility? The rate of eligibility will be determined as a raw percentage of the total number eligible over the total pool of participants entering the site.
Therapist acceptability of treatment as measured by questions on the Intervention Appropriateness Measure (IAM)
时间窗: 6 weeks
What are the therapists' perceptions of providing the MAPP intervention in a synchronous group format? For the acceptance of the virtual format, the therapists will complete the Intervention Appropriateness Measure (IAM), a four-item implementation measure that has been referred to as the "leading indicators" of successful implementation with shown psychometric strength and completion time being less than 1 minute.
Reasons for non-participation as recorded by participants
时间窗: 11 months
Among pregnant women who screen positive for anxiety, what are the reasons for non-participation? Reasons for nonparticipation will also be calculated as a proportion.
Participant Adherence to therapy as measured by proportion of participants who attend each session of therapy
时间窗: 4 weeks
What proportion of participants attend each session of therapy Proportion of participants completing each session over all participants for the session
Therapist acceptability of treatment as measured by the Feasibility of Intervention Measure (FIM) Questionnaire
时间窗: 6 weeks
What are the therapists' perceptions of providing the MAPP intervention in a synchronous group format? For the acceptance of the virtual format, the therapists will complete the Feasibility of Intervention Measure (FIM) a four-item implementation measure that has been referred to as the "leading indicators" of successful implementation with shown psychometric strength and completion time being less than 1 minute.
Participant Adherence to therapy as measured by proportion of participants who attend all sessions of therapy
时间窗: 4 weeks
What proportion of participants all therapy session Proportion of participants completing all sessions over all participants
The rate of recruitment as assessed by the number of participants recruited
时间窗: 11 months
Among eligible pregnant women who screen positive for anxiety, what is the rate of recruitment? The rate of recruitment will be determined as a raw percentage of the number recruited over the number eligible.
Participant acceptability of treatment as measured by the Treatment Acceptability Scale
时间窗: 6 weeks
What are participants' level of perceived acceptability of the MAPP intervention? The Treatment Acceptability Scale (TAAS) will be used to assess participant acceptability of the intervention. It is a 10 item self report questionnaire where items were developed based on several factors including credibility, expectancy and perceived gaps specifically in the anxiety disorders literature. A 7-point Likert scale is used where higher scores indicate higher acceptability and anticipation to adhere to the intervention. The scale has good psychometric properties and is recommended for evaluating anxiety interventions.
Participant acceptability of treatment as measured by the Acceptability of Internet Delivery (AID)/ Experiences of Therapy Questionnaire
时间窗: 6 weeks
What are participants' level of perceived acceptability of the synchronous virtual group format? For the acceptability of internet delivery (AID), we will use questions that rate the importance of advantages and disadvantages of internet therapy in making a decision regarding using versus rejecting it.
Therapist acceptability of treatment as measured by the Acceptability of Intervention Measures
时间窗: 6 weeks
What are the therapists' perceptions of providing the MAPP intervention in a synchronous group format? For the acceptance of the virtual format, the therapists will complete the Acceptability of Intervention Measure (AIM) a four-item implementation measure that has been referred to as the "leading indicators" of successful implementation with shown psychometric strength and completion time being less than 1 minute.
Participant Adherence to therapy as measured by the number completing follow-up questionnaires at 6, 12, and 24 weeks
时间窗: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
What number complete all questionnaires at 6,12 and 24 weeks Proportion of participants over all at each time point
Participant Adherence to therapy as measured by recorded reasons for dropout
时间窗: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
What are the reasons for drop out? Participants who drop out will be asked why and their answers will be recorded
Therapist Adherence to Therapy as assessed by therapist adherence checklists
时间窗: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
What are the therapists' rate of adherence to the intervention? We will rate the therapists' adherence to the trial protocol by having independent assessors rate adherence by completing a checklist devised for the study intervention based on a previous successfully used framework. Comparisons will be made between therapists and their adherence rates
次要结局
- Anxiety symptoms as measured by the GAD-7(After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy)