Painhunting Therapy for Event Related Depression (NCT07490691) | Clinical Trial Compass
CompletedNot Applicable
Painhunting Therapy for Event Related Depression
Kazakhstan84 participantsStarted 2026-03-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Active suicidal ideation with plan (PHQ-9 item 9 score of 3).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PHQ-9 (Patient Health Questionnaire-9) Score
Timeframe: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
. 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.