Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
This randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. The primary outcome is depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) at six weeks after randomization. Secondary outcomes include anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and durability of outcomes at 10 to 12 weeks. The study will also assess treatment fidelity, therapeutic alliance, and selected potential moderators of treatment response. The trial uses a randomized, rater-blinded, parallel-group design with an adaptive sample-size approach.
详细描述
The purpose of this study is to compare the effectiveness of Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT), an established psychological treatment for depression, in adults experiencing depressive symptoms associated with adverse life events.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The Painhunting Therapy arm will receive a brief structured course of therapy, with a minimum planned dose of three sessions except for participants meeting prespecified early-remission criteria, and additional sessions permitted when clinically indicated. The CBT arm will receive manualized CBT for depression delivered over approximately six to eight sessions. The intended primary treatment comparison is approximately three Painhunting sessions versus six CBT sessions, reflecting the typical delivery format of each intervention rather than a matched-dose comparison.
The primary endpoint is PHQ-9 score at six weeks after randomization. Additional assessments will examine depressive symptoms at earlier and later time points, anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and maintenance of outcomes at 10 to 12 weeks.
Outcome assessments at key follow-up time points will be conducted by assessors blinded to treatment allocation. Treatment adherence and fidelity will be independently assessed in both treatment arms using prespecified treatment-specific rating instruments.
The trial will initially enroll 30 participants, with 15 participants per treatment arm. An interim analysis and prespecified adaptive sample-size procedure will determine continuation toward a planned final analyzed sample of 60 participants, with 30 participants per arm, unless a prespecified stopping criterion is met.
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)
盲法说明
Outcome assessors administering assessments at T2, T3, and T4 are blinded to treatment allocation. Participants and treating therapists are not blinded due to the nature of the psychotherapeutic interventions. Statistical analyses are performed using blinded group coding until the primary analysis is locked.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •PHQ-9 score of 9 or greater at screening.
- •At least one adverse life event within the prior 24 months, documented using the Life Events Threshold (LTE) instrument.
- •Resident of Kazakhstan.
- •Fluent in Russian.
- •Capacity to provide written informed consent.
- •Willing to attend at least six sessions within the protocol treatment schedule.
排除标准
- •Active suicidal ideation requiring immediate referral, defined as PHQ-9 item 9 score of 3 or clinical judgment of imminent risk.
- •Active psychosis or mania.
- •Active substance use disorder meeting DSM criteria.
- •Current psychotherapy with another provider.
- •Initiation of pharmacotherapy within the prior four weeks.
- •Pre-existing stable antidepressant monotherapy unchanged for eight weeks or longer is permitted.
- •Inability to provide informed consent in Russian.
结局指标
主要结局
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
时间窗: 6 weeks post-randomization
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, each scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms. The primary comparison between treatment groups will evaluate PHQ-9 scores at six weeks post-randomization, adjusting for baseline PHQ-9.
次要结局
- Treatment and study dropout rate(Through 10 to 12 weeks post-randomization)
- Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)(2 weeks and 10 to 12 weeks post-randomization)
- Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7)(Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization)
- Event-related distress measured by the Impact of Event Scale-Revised (IES-R)(Baseline, 6 weeks, and 10 to 12 weeks post-randomization)
- Protocol deviation rate(Through 10 to 12 weeks post-randomization)
- Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG)(Baseline, 6 weeks, and 10 to 12 weeks post-randomization)
- Functional impairment measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0)(Baseline, 6 weeks, and 10 to 12 weeks post-randomization)
- Treatment response based on PHQ-9(6 weeks and 10 to 12 weeks post-randomization)
- Remission based on PHQ-9(6 weeks and 10 to 12 weeks post-randomization)
- Number of treatment sessions received(From treatment initiation through completion of the active treatment period, approximately 4 weeks)
研究者
Uzakova Sanemkhan
Principal Investigator, Endocrinologist
Painhunting LLP