Efficacy of Painhunting Therapy for Event-Related Depression: A Waitlist-Controlled Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in PHQ-9 (Patient Health Questionnaire-9) Score
研究概览
简要总结
This pilot randomized controlled trial evaluates the efficacy of Painhunting therapy, a brief structured psychotherapy, for adults with depressive symptoms following adverse life events in Kazakhstan. Eighty-four participants with a history of at least one adverse life event documented by the List of Threatening Experiences (LTE, lifetime version) and a baseline PHQ-9 score of 10 or greater were randomized 1:1 to immediate treatment or a waitlist control. The intervention uses an adaptive treat-to-target design: all treatment-arm participants receive three mandatory individual sessions, with up to three additional sessions (maximum six total) for those meeting pre-specified continuation criteria at the midpoint. The primary outcome is depressive symptom severity measured by the PHQ-9 at Time 2 (2 weeks post-randomization). Recruitment closed on April 14, 2026.
详细描述
Depressive symptoms following adverse life events (bereavement, divorce, job loss, financial crisis, serious illness, and related events) affect a substantial minority of exposed individuals and are associated with functional impairment and reduced quality of life. Painhunting therapy is a structured psychotherapeutic approach developed by Olzhas Seitov that targets root traumatic incidents underlying persistent distress. Retrospective practice data from 128 cases suggest clinically meaningful symptom improvement, but no controlled trial had been conducted prior to this study.
This trial uses a waitlist-controlled design with stratified block randomization, blinded statistical analysis, and pre-registered analysis (SAP v1.1 preregistered on OSF prior to examination of between-group post-treatment data). The intervention follows an adaptive treat-to-target protocol. Phase 1 consists of three mandatory individual therapy sessions (1.5 to 2 hours each) over three to four weeks. At the end of session 3, participants complete the PHQ-9 and the therapist completes a structured Therapist Assessment Form. Participants meeting both pre-specified continuation criteria (PHQ-9 at or above 10 or less than 50 percent reduction from baseline; and therapist assessment that the root traumatic incident has not been accessed) proceed to Phase 2, receiving up to three additional sessions (maximum six total). Participants not meeting continuation criteria conclude treatment after session 3.
Eligibility uses the LTE (lifetime version) as the adverse life event documentation instrument, with a PHQ-9 severity threshold of 10 or greater serving as the primary clinical gate. Baseline measures include the General Self-Efficacy Scale (GSE, 10 items, administered at T0 only) and four custom readiness items (Seitov 2026), analyzed as pre-specified treatment-response moderators rather than eligibility criteria or T2 outcomes.
The study is coordinated from Astana, Kazakhstan, with sessions delivered in person or via secure video conferencing. Assessment and therapy are conducted in Russian and Kazakh; language preference is captured at enrollment and included as an analytic covariate in the primary and secondary outcome analyses.
Final enrollment: 84 participants randomized, 42 per arm, in 1:1 allocation. Stratified by baseline PHQ-9 severity band and age category; language preference recorded as analytic covariate. Recruitment closed April 14, 2026. Sample size justification: ANCOVA with baseline PHQ-9 as covariate, r = 0.5, two-tailed alpha 0.05, 80 percent power detects a standardized mean difference of d = 0.53 or larger at n = 42 per arm. Usable completer analysis sets of 40 (Group A) and 34 (Group B) after post-randomization attrition retain 80 percent power to detect d = 0.58 or larger.
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
Due to the nature of the psychological intervention, participants and therapists cannot be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •History of at least one adverse life event documented by the List of Threatening Experiences (LTE, lifetime version, Brugha et al., 1985).
- •PHQ-9 score of 10 or above at screening.
- •Able to attend therapy sessions in person or via secure video.
- •Provides written informed consent.
排除标准
- •Active suicidal ideation with plan (PHQ-9 item 9 score of 3).
- •Current psychotic symptoms.
- •Currently receiving other psychotherapy at enrollment.
- •Substance dependence requiring medical management.
- •Current or concurrent enrollment in any Painhunting training, educational, workshop, or reading-group program during the trial period or the three months preceding enrollment. (Note: this exclusion criterion is being applied retroactively via a documented audit, following surfacing of a single case of concurrent exposure. See 'Protocol Deviations and Quality Assurance' below.) Eligibility rationale: The prior protocol specified interpersonal loss (bereavement, divorce, relationship dissolution) within a 0 to 180 month window. Amendment 3 broadens this to any adverse life event documented by LTE. The LTE is a 12-item instrument designed specifically for depression research, with lifetime-version adaptations validated in multiple populations. Using LTE as the documentation instrument provides a defensible, research-standard definition of adverse life event exposure and removes the artificial narrowing to interpersonal losses alone.
研究组 & 干预措施
No Intervention - Waitlist Control
Waitlist control. Participants wait approximately two weeks (timed to the Time 2 assessment) with brief bi-weekly safety contact and psychoeducational materials. Full treatment is offered after the waiting period per the ethically-required crossover design.
Experimental - Painhunting Therapy
Painhunting Therapy, adaptive. Phase 1 (mandatory): three individual therapy sessions (1.5 to 2 hours each) over three to four weeks using the Painhunting method (OS Method, Replay Method, Repeater Method, 5-Step Diagnostic Algorithm, Confirmation Protocol). Midpoint assessment at end of session 3 using PHQ-9 and the Therapist Assessment Form. Phase 2 (conditional): up to three additional sessions (maximum six total) for participants meeting both continuation criteria described above. Delivered by trained Painhunting therapists, with therapist assignment tracked for random-effects modeling.
干预措施: Painhunting Therapy (Behavioral)
结局指标
主要结局
Change in PHQ-9 (Patient Health Questionnaire-9) Score
时间窗: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
PHQ-9 (Patient Health Questionnaire-9) at Time 2 (2 weeks post-randomization), adjusted for baseline PHQ-9 (T0) and language preference covariate using ANCOVA. Scale range 0 to 27; higher scores indicate greater depressive symptom severity. Measurement: participant self-report. Change from prior posting: The prior registry record listed PHQ-9 and ICG as co-primary outcomes. Amendment 3 removed ICG from the primary outcome position. The Statistical Analysis Plan (SAP v1.1, preregistered on OSF) designates PHQ-9 at T2 as the sole primary outcome, with ICG at T2 as the leading secondary outcome. This narrowing of the primary hypothesis was locked prior to examination of any between-group T2 outcome data. Rationale: (a) the PHQ-9 recall-window bias direction is conservative for a two-week T2 (the treatment arm score reflects a mixture of pre-treatment and post-treatment experience, which works against the effect, not for it); (b) empirical administration of the GIC in early T2 assessments
Change in PHQ-9 (Patient Health Questionnaire-9) Score
时间窗: Baseline (T0) to post-treatment/end of wait (T2, approximately week 4)
Self-report measure of depression severity (range 0-27). Higher scores indicate more severe depression.
Change in ICG (Inventory of Complicated Grief) Score
时间窗: Baseline (T0) to post-treatment/end of wait (T2, approximately week 4)
Self-report measure of complicated grief symptoms (range 0-76). Scores of 25 or higher indicate clinically significant complicated grief.
次要结局
- Change in GAD-7 Score (Anxiety)(Time Frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2))
- Change in ICG (Inventory of Complicated Grief) Score(Baseline (T0) to post-treatment/end of wait (T2, approximately week 2))
- Change in WHO-DAS 2.0 12-Item Score (Functional Disability)(Baseline (T0) to post-treatment/end of wait (T2, approximately week 2))
- GIC (Global Impression of Change) at T2(2 weeks post-randomization (T2))
- Change in GAD-7 Score (Anxiety)(Time Frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 4))
- Change in PCL-5 Score (PTSD Symptoms)(Baseline (T0) to post-treatment/end of wait (T2, approximately week 4))
- Change in WHO-DAS 2.0 12-Item Score (Functional Disability)(Baseline (T0) to post-treatment/end of wait (T2, approximately week 4))
- Maintenance of Treatment Gains in PHQ-9 and ICG Scores(Post-treatment (T2) to 3-month follow-up (T3, approximately week 16))
研究者
Uzakova Sanemkhan
MD, General Practitioner (licensed physician)
Painhunting LLP