A Randomized Controlled Trial of an Attachment Based Approach for Anxiety and Depression, Emotionally Focused Individual Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
研究概览
简要总结
The purpose of the current study is to examine the efficacy of Emotionally Focused Therapy for Individuals (EFIT) as a treatment for depression and anxiety. It is formulated as a trans-diagnostic treatment in line with the call for more transdiagnostic approaches to treat depression and anxiety given the many similarities in the underlying psychological and emotional factors of these disorders, the high levels of co-morbidity, and the preliminary success of transdiagnostic treatment approaches. EFIT has been formulated as an attachment-based alternative to current cognitive transdiagnostic approaches. The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions. EFIT has been formulated for the first time this year in the book that will serve as the therapy manual for this study. The current study aims to examine EFIT outcomes as compared to a control group (a wait-list control followed by online CBT intervention after the wait period). In particular, this research project aims to distinguish differences in initial and follow-up outcomes between EFIT versus control, and demonstrate significant changes in attachment/emotions and mechanisms of change across EFIT sessions. The primary hypotheses are outlined below.
详细描述
PROCEDURES
Recruitment Participants are recruited from the general population of individuals self-identifying as having symptoms of depression and/or anxiety in each study site (Ottawa, Denver, Victoria). Study advertisements are posted and circulated through post-secondary institutions, online, and within psychotherapy treatment centres. Participants experiencing depression and/or anxiety are invited to contact the research coordinator of the project via the email listed on recruitment material. All interested participants receive a telephone screen by research research assistants to assess potential eligibility. Participants who are deemed potentially eligible are informed that they will be contacted by an assessor to be invited for an initial study assessment session to determine final eligibility.
Baseline assessment Assessors are individuals with clinical experience in psychotherapy or counselling at each of the study sites. Informed consent is reviewed and participants have the opportunity to have all their questions and concerns addressed. Assessors administer the diagnostic criteria modules of the ADIS-5 during this session. Assessments take place either within the private practice locations at each study site or the university offices of the investigators in a research session lasting approximately 1-2 hours. During the pandemic while it is not safe to meet in person, secure encrypted video call platforms are used to hold these sessions. Responses are evaluated by the assessors' supervisors, at which point final eligibility is determined. The assessments and therapy take place either within the private practice locations at each study site as specified or the university offices of the co-investigators, or online using a secure encrypted video call platform when it is unsafe to meet for in-person sessions due to the pandemic. After completion of the baseline assessment session, eligible participants are given access to an online questionnaire to complete at their own convenience. After completion of the questionnaire, participants are randomly assigned to study condition.
Random assignment Once participants have been deemed eligible to take part, and have completed the baseline questionnaire, they are randomly assigned to the EFIT (treatment) condition or the waitlist plus online CBT (control group) condition by the research co-ordinator. A list of numbers (i.e., 1-40 for Ottawa, 1-28 for Victoria, and 1-20 for Denver) are generated for each city, reflecting the total number of EFIT and control clients for that city. Within those groups, a separate randomized list (i.e., 20 total numerical values for Ottawa, 14 for Victoria, and 10 for Denver) is generated using Research Randomizer, an online tool for random assignment that has been used in previous RCT studies. As participants are deemed eligible, they are added onto the list and their number will determine whether they will take part in either the EFIT intervention or the control group.
Interventions:
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 (Outcomes Assessor)
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
- •Primary diagnosis of Major Depressive Disorder with co-morbid symptoms of anxiety
- •Inclusion cut offs: Participants must score in the mild-to severe range on BDI-II and mild-moderate on the BAI
- •At least 18 years old
排除标准
- •Psychotropic medication change in 6 weeks prior to enrollment or anticipated during the study period (this allows us to include people who are taking a medication but mitigates the risk of medication changes as a problematic factor; assessed in phone screen)
- •Current DSM diagnosis of bipolar disorder, schizophrenia-spectrum disorder, PTSD, eating disorder, personality disorder, or substance abuse or dependence
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System-Anxiety Scale (PROMIS Anxiety)
时间窗: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
The Patient-Reported Outcomes Measurement Information System-Anxiety scale is an 8-item tool designed to measure participants' self-reported anxiety symptoms over the past week. Participants are asked to respond to eight anxiety-related statements on a 5-point Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=always).
Beck Anxiety Inventory (BAI)
时间窗: Change from baseline to week 5, week 7 and completion of 15-week intervention, and at 3, 6, 9, and 12 months after completing the intervention
The Beck Anxiety Inventory is a 21-item self-report questionnaire used to assess common symptoms of anxiety (e.g., rapid heartbeat, sweating, numbness, trembling, etc.). Participants are presented with a list of common symptoms of anxiety and are asked to note how much they experienced each over the past week from a four item Likert scale ("not at all", "mildly", "moderately", and "severely"). The total score is calculated by finding the sum of all 21 items; a score of 0-21 indicated low anxiety, 22-35 indicates moderate anxiety, and a score of 36 and above indicates potentially concerning levels of anxiety. Both of the Beck inventories used in this study have been widely used in clinical research and possess good reliability and validity. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI-2 after session 5 and 7.
Patient-Reported Outcomes Measurement Information System-Depression Scale (PROMIS Depression)
时间窗: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
The Patient-Reported Outcomes Measurement Information System-Depression scale is an 8-item scale used to measure participants' self-reported depression symptoms over the past week. Participants are asked to respond to eight depression-related statements on the same 5-point Likert scale as the PROMIS-Anxiety measure.
Beck Depression Inventory-2 (BDI-2)
时间窗: Change from baseline to week 5, week 7, completion of 15-week intervention, and 3, 6, 9 and 12 months following the intervention.
The Beck Depression Inventory-2 is a 21-item self-report questionnaire used to assess the severity of depressive symptoms (e.g., sadness, guilt, crying, suicidal thoughts, etc.). Participants are presented with a list of themes and are asked to choose a statement that best fits their mood over the past two weeks. Each statement has a corresponding numerical value. The sum all statements are calculated for scoring purposes. A score of 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and a score above 29 indicates severe depression. Participants will complete this questionnaire in paper format at the baseline and post assessment sessions. EFIT participants will also complete the BDI after session 5 and 7.
Outcome Questionnaire-30.2
时间窗: Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.
The Outcome Questionnaire-30.2 is a brief 30-item instrument intended to measure client progress before, during, and following clinical interventions. This questionnaire is was adapted from the OQ-45, is highly sensitive to session-by-session changes, and possesses high levels of reliability and validity. Over the course of the study, this questionnaire will be repeatedly administered in order to monitor participants' progress through the EFIT and waitlist conditions. This questionnaire will also be administered during the 4 follow-up time points.
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)
时间窗: Change from baseline to completion of the 15 week wait period.
The ADIS-5 is a structured interview intended to help clinicians diagnose psychological disorders based on DSM-5 criteria. The ADIS-5 also allows for differential diagnosis and has been widely used in clinical research. Assessors will administer the ADIS-5 and determine whether or not the participants the criteria for a diagnosis of anxiety and/or depression, and to assess change at post 15-week wait period.
次要结局
- Trauma Symptom Inventory-2(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Inventory of Interpersonal Problems-32(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Reflective Function Questionnaire-8 (RFQ)(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Leuven Affect and Pleasure Scale(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Sociodemographic Questionnaire(Baseline)
- Multi-dimensional Assessment of Interoceptive Awareness(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Working Alliance Inventory(Weekly for 15 weeks of the experimental condition)
- Childhood Trauma Questionnaire-Short Form(Baseline)
- Experiences in Close Relationships Questionnaire (ECR)(Change from baseline, to across each week for 15 weeks, to after completion of the 15-week wait-period, and at 3, 6, 9, and 12 months after completing the 15-week wait-period.)
- Patient-Reported Outcomes Measurement Information System-Meaning (PROMIS Meaning)(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Post Session Resolution Questionnaire (PSQR)(Weekly for 15 weeks of the experimental condition)
- Difficulties in Emotion Regulation Scale(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
- Rosenberg Self-Esteem Scale(Change from baseline to week 5, week 7, and completion of 15-week intervention, and across 3, 6, 9, and 12 month follow-up time points)
研究者
Stephanie Wiebe
Assistant Professor
Saint Paul University