Painhunting Therapy for Event Related Depression

NCT07490691 | Completed

• 1 other identifier: PH-GRIEF-RCT1-2026-WL
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interpersonal Loss; Complicated Grief; Loss-Related Depression

Keywords

Painhunting Therapy; Interpersonal Loss; Depression; Complicated Grief; Psychotherapy; Emotional Trauma; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in PHQ-9 (Patient Health Questionnaire-9) Score

  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

  Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)

Secondary Outcomes (5)

• 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)

• Maintenance of Treatment Gains in PHQ-9 and ICG Scores

  Post-treatment (T2) to 3-month follow-up (T3, approximately week 16)

• GIC (Global Impression of Change) at T2

  2 weeks post-randomization (T2)

Other Outcomes (7)

• Working Alliance Inventory - Short Revised (WAI-SR)

  After session 1 (Approximately Week 1)

• Credibility/Expectancy Questionnaire (CEQ)

  Baseline

• Session Mechanism Checklist

  After each therapy session (up to 6 sessions), over approximately 4 weeks

Study Arms (2)

Experimental - Painhunting Therapy

EXPERIMENTAL

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.

Behavioral: Painhunting Therapy

No Intervention - Waitlist Control

NO INTERVENTION

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.

Interventions

Painhunting Therapy BEHAVIORAL

Painhunting therapy is a structured psychotherapeutic intervention designed to identify emotionally significant past experiences associated with current psychological distress and facilitate emotional processing of these experiences. The intervention consists of three individual sessions delivered over 3-4 weeks by trained practitioners.

Experimental - Painhunting Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Painhunting LLP: lead

Study Sites (1)

Painhunting Research Center

Astana, Astana, 010000, Kazakhstan

Location

Related Links

• Statistical Analysis Plan (SAP v1.1) and preregistration materials

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the psychological intervention, participants and therapists cannot be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, General Practitioner (licensed physician)

Model Details: Participants will be randomly assigned to either a Painhunting therapy intervention group or a waitlist control group. The intervention group will receive structured therapeutic sessions, while the waitlist control group will receive the intervention after completion of the study period.

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 24, 2026
• Study Start: March 23, 2026
• Primary Completion: June 6, 2026
• Study Completion: June 6, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified participant data will become available after publication of the primary study results and will remain available for at least 5 years following publication.
• Access Criteria: Access to de-identified individual participant data will be granted to qualified researchers upon reasonable request to the Principal Investigator. Requests will be evaluated based on the scientific merit of the proposed research and compliance with ethical and data protection standards.

Locations

KA (1)