ACTRN12623000383662已完成Unknown
An Online Mindfulness-Based Intervention for Psychological Distress Associated with Inflammatory Bowel Disease in Adults: A Feasibility Trial of the Mind4IBD Program
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adults aged 18 years or older.
- •- Diagnosis of IBD (including Ulcerative Colitis or Crohn's Disease subtypes). IBD diagnosis needs to be established by a health professional using standard criteria. Participants will need to provide evidence of their diagnosis, this can include a letter from a doctor (e.g., GP or Gastroenterologist), results of endoscopy, or any other medical document confirming their diagnosis. Screening for this will take place after consent has been obtained and evidence will be destroyed after verifying participants study eligibility.
- •- Evidence of moderate to high psychological distress. This will be verified by a score between 16-29 on K10. Screening for distress will take place after consent has been obtained.
- •- Able to communicate in English.
- •- Access to the internet to participate in the online intervention.
- •- Live in Australia
- •; - Adults aged 18 years or older.
- •- Diagnosis of IBD (including Ulcerative Colitis or Crohn's Disease subtypes). IBD diagnosis needs to be established by a health professional using standard criteria. Participants will need to provide evidence of their diagnosis, this can include a letter from a doctor (e.g., GP or Gastroenterologist), results of endoscopy, or any other medical document confirming their diagnosis. Screening for this will take place after consent has been obtained and evidence will be destroyed after verifying participants study eligibility.
- •- Evidence of moderate to high psychological distress. This will be verified by a score between 16-29 on K10. Screening for distress will take place after consent has been obtained.
- •- Able to communicate in English.
- •- Access to the internet to participate in the online intervention.
- •- Live in Australia
排除标准
- •- No/low psychological distress (represented by scores <16 on K10) or very high psychological distress (represented by scores >29 on K10). It is anticipated that participants with more severe distress would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will receive a message embedded in the Qualtrics screening process to indicate they are not eligible to participate in the study due to screening for severe distress, and it will be recommended that they seek additional support from other appropriate providers. In the same manner participants with no distress will also receive a message stating that they are not eligible to participate in the study due to screening for no distress. ; - No/low psychological distress (represented by scores <16 on K10) or very high psychological distress (represented by scores >29 on K10). It is anticipated that participants with more severe distress would require a more intensive therapeutic approach before benefiting from the current intervention. These participants will receive a message embedded in the Qualtrics screening process to indicate they are not eligible to participate in the study due to screening for severe distress, and it will be recommended that they seek additional support from other appropriate providers. In the same manner participants with no distress will also receive a message stating that they are not eligible to participate in the study due to screening for no distress.
研究者
相似试验
进行中（未招募）
1 期
An experimental study in men and women with head and neck cancer to test the safety, tolerability and the effects of addition of a vaccine directed against an infection with Human Papilloma virus Type 16 (HPV16) in combination with an antibody that activate part of the immune systemEUCTR2018-000789-13-BEISA Therapeutics B.V.194
进行中（未招募）
1 期
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First RelapseFirst relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignanciesMedDRA version: 9.1 Level: LLT Classification code 10033160 Term: Ovarian epithelial cancer recurrentEUCTR2008-005872-29-FREisai Limited
进行中（未招募）
不适用
Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First RelapseFirst relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignanciesMedDRA version: 14.0Level: PTClassification code 10033160Term: Ovarian epithelial cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-005872-29-NLEisai Limited1,080
招募中
1 期
A Study to evaluate Efficacy, Safety, Tolerability and Effects of TAK-341 in the human body in patients with Multiple System AtrophyMedDRA version: 21.1Level: PTClassification code 10064060Term: Multiple system atrophySystem Organ Class: 10029205 - Nervous system disordersMultiple System AtrophyEUCTR2022-000336-28-DKTakeda Development Center Americas, Inc.138
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First RelapseFirst relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignanciesMedDRA version: 9.1Level: LLTClassification code 10033160Term: Ovarian epithelial cancer recurrentEUCTR2008-005872-29-GREisai Limited900