Unified Protocol for Transdiagnostic Treatment: An Adaptation and Pilot RCT for the Treatment of Depression and Anxiety in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Feasibility- Recruitment method
研究概览
简要总结
To conduct a pilot randomized controlled trial (RCT) of a culturally adapted Unified Protocol (UP) for transdiagnostic psychological treatment in adults (age 18 and above) with anxiety and/or depression to assess the feasibility and acceptability of UP treatment.
The main questions it aims to answer are:
- To assess the estimates of likely recruitment rates including how many approached, volunteered, screened, retained, and complete the treatment and what is the dropout rate?
- To what degree do participants adhere and engage with the treatment procedures?
- To what extent do the participants feel satisfied with the treatment?
- To what degree do participants complete self-report and clinician-administered measures of anxiety, depression, functional impairment, and emotion regulation?
- What is the treatment outcome with regard to emotion regulation, symptoms of anxiety, depression, functional impairment, and emotion regulation?
The participants will be randomized to either the treatment group or the control group. The treatment group will receive 14 sessions of one-on-one individual treatment with the Unified Protocol. The control group will receive no treatment.
详细描述
Most patients with depression and anxiety in low-resource settings don't get evidence-based treatment. Transdiagnostic approaches like UP are promising for these settings because they are multi-problem, modular, flexible, and have low complexity. The present study aimed to investigate the initial acceptability and feasibility of the adapted Unified Protocol (UP) in relation to its quantitative and qualitative effects on attendance, homework compliance, satisfaction, and perceived usefulness of the intervention. Additionally, the study aimed to evaluate the preliminary effects of the adapted UP on depression, anxiety, functional impairment, and emotion regulation among adults suffering from anxiety, depression, and/or comorbidity of both disorders.
A sample size of approximately 50 adults will be recruited from mental health facilities and online dissemination of the study. After screening through the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI), and assessing the inclusion and exclusion criteria, those who demonstrate moderate to severe scores on the BDI-II and BAI will be further evaluated by the principal investigator using the Structured Clinical Interviews for DSM-5 (Research Version) (SCID-5-RV) to determine their diagnosis. Once the eligibility criteria are met, participants will be randomly assigned to one of two study conditions:
Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment.
Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
Participants from both groups will complete several assessment measures at baseline, mid-treatment (only at week 7 of the UP), and post-treatment.
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
盲法说明
To ensure blinding of participants and intervention facilitator, a randomizing researcher, who is different from the facilitator, will generate the sequences and assign an ID (1-50) to one of the groups based on the sequence. The sealed envelopes will be given to the facilitator, who will open the envelope in the interview and inform the participants about their allocated group. This will ensure that neither the participants nor the facilitator will know which group they are assigned to, which will help to minimize bias in the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffering from anxious and/or depressive disorder
排除标准
- •suicide risk at the time of assessment
- •comorbidity of pervasive developmental disorder
- •comorbidity of psychotic disorders
- •severe physical illness
- •receiving concurrent psychotherapy
- •receiving psychopharmacological treatment
结局指标
主要结局
Feasibility- Recruitment method
时间窗: 14 weeks
The number of participants recruited by each of the three methods used for recruiting. The methods will be: mental health facilities, online dissemination, and referrals and recommendations.
Acceptability of the treatment
时间窗: 14 weeks
It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Feasibility of outcome measures
时间窗: 14 weeks
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
Acceptability of randomization
时间窗: 14 weeks
The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.
Acceptability of the treatment - Semi-structured interview
时间窗: 14 weeks
Semi-structured interview by an independent interviewer will be conducted to obtain responses on a number of indicators including; Participants' overall satisfaction with the treatment, understand the overall content covered in the treatment, the perceived usefulness of the techniques learned, the discomfort it generated, the likelihood that participants would choose such a treatment again, their recommendation to friends or family, what they found most, what they find least helpful, any modifications they would recommend.
Feasibility: Eligibility criteria
时间窗: 14 weeks
Assessed through the number of participants fulfilling the eligibility criteria from the total number of participants registered, number of ineligible participants, and reasons for ineligibility.
Feasibility- Recruitment rate
时间窗: 14 weeks
To assess the estimates of likely recruitment rates, including: How many participants approached? How many participants volunteered? How many participants were screened? How many participants were retained in the study? What was the dropout rate? The number of participants completing the final assessment (assessed through a record made at each session).
Feasibility- Weekly face-to-face sessions
时间窗: 14 weeks
The nature of barriers that may lead to participants dropping out of treatment can be assessed by examining the number and type of problems that they experienced while attending weekly sessions. These problems include transportation difficulties, work or educational demands, childcare difficulties, scheduling conflicts, and treatment procedures interfering with daily life. Followed by an open-ended question that will assess any other reason to discontinue the treatment.
Feasibility - Treatment adherence and engagement
时间窗: 14 weeks
Engagement in treatment will be assessed using the Homework Rating Scale-Revised, a 12-item measure that assesses beliefs, consequences, and engagement with treatment homework activities. Total scores range from 0 to 48 on this scale, where higher scores indicate higher commitment to the treatment. Treatment adherence will be further assessed by tracking participant attendance, percentage of intervention completion, and number of sessions completed.
Feasibility - Semi-structured Interview for treatment adherence and engagement
时间窗: 14 weeks
Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.
次要结局
- Beck Depression Inventory-II(14 weeks)
- Beck Anxiety Inventory(14 weeks)
- Work and Social Adjustment Scale(14 weeks)
- Difficulties in Emotion Regulation Scale(14 weeks)
- Positive and Negative Affect Schedule(14 weeks)
研究者
Asma Nisa
Primary Researcher
National University of Science and Technology, Pakistan