The Internet Therapy for Depression Trial (INTEREST): A Doubly-randomized, Patient-preference, Controlled Feasibility Trial Comparing iACT, iCBT, and Attention Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Screening and Consent Rates
研究概览
简要总结
The objective of this trial is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) interventions tailored towards the treatment of depression and chronic pain using a doubly-randomized, attention-controlled, non-blinded, patient-preference design.
详细描述
The primary objective is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) on depressed mood among individuals with chronic pain relative to attention control (AC). The secondary objectives are to evaluate the efficacy of iCBT and iACT on clinically relevant outcomes endorsed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Adults with chronic non-cancer pain and major depression will be randomized to receive iACT, iCBT, or AC. The interventions comprise 7 weekly online modules available through Therapist Assisted Online (TAO). Patients will be contacted weekly by a member of the study team who will be acting as their personalized "online therapy coach."
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
- Double (Investigator, Outcomes Assessor)
盲法说明
A research assistant not affiliated with the study will use Research Randomizer (http://www.randomizer.org/) to generate lists of randomly sequenced numbers to allocate patients to trial arm. To reduce biases and expectation effects, the research assistant will not be aware of what condition the patients are allocated when conducting baseline assessments and a research assistant not affiliated with the research will complete outcome assessments without being aware of allocation. Interventionists will be aware of which group patients are allocated to, as will patients.
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
- •Fluent in English
- •18 years of age or older
- •have a primary diagnosis of chronic non-cancer pain.
- •meet DSM-5 criteria for a diagnosis of major depressive disorder
- •have access to the internet, email, and telephone
- •can commit to the demands and timelines of the trial.
- •Given high comorbidity in this population, patients with sleep disturbance or comorbid anxiety will also be eligible to participate.
排除标准
- •diagnosis of cognitive impairment (e.g., dementia)
- •active suicidal ideation
- •severe psychopathology (e.g., schizophrenia)
- •unable to sign a safety contract for the duration of the trial
- •concurrent participation in psychotherapy.
结局指标
主要结局
Screening and Consent Rates
时间窗: Through study completion, up to 2-years
The number of patients with CNCP and suspected major depression who are referred for screening will be recorded. Eligibility rate will be calculated as the number of patients who meet full inclusion criteria divided by the number of patients referred for screening. Number of patients declining referral for screening and reasons for exclusion will be documented. Consent rate will be calculated by dividing the number of patients who consent to undergoing randomization by the number who met full inclusion criteria.
Adherence to intervention measured as frequency of visits to online modules.
时间窗: End of treatment (i.e., week 8)
Intervention adherence will be measured using data recorded by Therapist Assisted Online (TAO) program and include: 1) frequency of visits to TAO modules throughout weeks 1 to 8.
Change in symptoms of depression measured using the Patient Health Questionnaire - 9 (PHQ-9)
时间窗: Change from baseline to end of treatment (i.e., week 8).
Change in symptoms of depression as measured using the PHQ-9 from baseline to post-intervention. Scores range from 0-27 with higher scores reflecting greater symptoms of depressed mood.
Perceived acceptability of treatment measured using qualitative interviews
时间窗: Completion of the intervention (i.e., week 8)
Acceptability data will be collected using semi-structured interviews with patients. Open ended questions will be asked to ascertain the following: 1) acceptability of the delivered intervention; 2) perceived value, benefits, harms and unintended consequences of the delivered intervention; 3) perceived need for refinement of the delivered intervention.
次要结局
- Change in physical function measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI-SF)(Baseline, 4-weeks, and post-intervention (i.e., week 8))
- Change in pain severity will be measured using the pain severity composite scale of the Brief Pain Inventory - Short Form (BPI-SF)(Baseline and through study completion, an average of 8-weeks.)
- Change in psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI).(Baseline and through study completion, an average of 8-weeks.)
- Mediators of change for cognitive behavioural therapy measured using change in the cognitive behavioural therapy skills questionnaire.(Baseline and through study completion, an average of 8-weeks.)
- Mediators of change for acceptance and commitment therapy measured using change in the acceptance and action questionnaire.(Baseline and through study completion, an average of 8-weeks.)
- Change in emotion function measured using the Depression, Anxiety Stress Scale - 21 (DASS-21).(Baseline and through study completion, an average of 8-weeks.)
研究者
Joshua Rash
Assistant Professor
Memorial University of Newfoundland