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Completed NCT07490691

Painhunting Therapy for Event Related Depression

Conditions: Loss-Related Depression, Interpersonal Loss, Complicated Grief

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Painhunting LLP

Location: Painhunting Research Center Astana Astana

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.

Eligibility Criteria

Inclusion Criteria: 1. Adults aged 18 years or older. 2. History of at least one adverse life event documented by the List of Threatening Experiences (LTE, lifetime version, Brugha et al., 1985). 3. PHQ-9 score of 10 or above at screening. 4. Able to attend therapy sessions in person or via secure video. 5. Provides written informed consent. Exclusion Criteria: 1. Active suicidal ideation with plan (PHQ-9 item 9 score of 3). 2. Current psychotic symptoms. 3. Currently receiving other psychotherapy at enrollment. 4. Substance dependence requiring medical management. 5. 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07490691). StuddyBuddy aggregates publicly available trial information.