Loss-Related DepressionPH-GRIEFNCT07490691
Painhunting Therapy for Event Related Depression
A study testing Painhunting Therapy in people with Loss-Related Depression and Interpersonal Loss, run by Painhunting LLP at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loss-Related Depression, Interpersonal Loss, Complicated Grief
- What is being tested?
- Painhunting Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteKazakhstan
- Study dates
- 23 Mar 2026to 6 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Painhunting Therapy for Event-Related Depression: A Waitlist-Controlled Randomized Pilot Trial
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.
Read the detailed description
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.
Approved by the Local Ethics Committee of al-Farabi Kazakh National University (IRB00010790; Protocol No. IRB-1970), initial approval dated March 5, 2026 (reference №210). Amendments approved: March 12, 2026 letter №213/2 (Amendment 1, protocol title change); April 2, 2026 letter №217 (Amendments 2 and 3 bundled, documentation items and LTE broadening with ICG repositioning); April 9, 2026 letter №218 (Amendment 4, timeline and GIC addition). Approval valid through March 4, 2027.
Screening funnel: 216 applications received; 146 completed screening questionnaire; 122 passed psychometric screening; 84 passed clinical interview and confirmed participation; 84 randomized.
Randomization: 42 to Group A (immediate treatment); 42 to Group B (waitlist). Group A post-randomization disposition: 40 in active therapy; 1 withdrew due to therapist preference; 1 lost to follow-up before first treatment session.
Group B post-randomization disposition: 34 in active waitlist; 1 withdrew due to disclosed concurrent external psychotherapy; 4 lost to follow-up; 3 declined continuation, payment-related.
Intention-to-treat population: all 84 randomized participants, regardless of post-randomization disposition.
Protocol Deviations and Quality Assurance Two methodological issues surfaced during T2 data collection have been addressed analytically and documented here for transparency.
Invalid-assessment retest rule: One Group B participant's first T2 PHQ-9 administration yielded a score that the participant retrospectively attributed to an acute transient mood state unrepresentative of the instrument's two-week recall window. Per SAP Section 10, developed in response to this case and locked prospectively before further T2 data examination, such cases trigger a standardized retest within 24 to 48 hours. The retest score supersedes the original for primary analysis. The original is retained in the dataset with an invalidity flag and enters sensitivity analysis. This rule is bilateral (either arm, either direction of implied bias) and is invoked by the study coordinator.
Concurrent training program exposure: One Group B participant was identified as concurrently attending a Painhunting training program, a potential co-intervention. An audit of all 74 active participants for concurrent or prior Painhunting training, workshop, reading-group, or educational program exposure is being conducted. Any documented exposure is retained in the intention-to-treat population and excluded from the per-protocol secondary analysis. A concurrent-training exclusion criterion has been added (Exclusion Criterion 5 above) and will be applied at screening in any subsequent trial.
Statistical Analysis Plan Availability The Statistical Analysis Plan (SAP version 1.1, dated April 16, 2026) is preregistered on the Open Science Framework (OSF) for this project. The SAP was finalized prior to examination of any between-group Time 2 outcome data. SAP v1.1 differs from v1.0 only in reclassifying the General Self-Efficacy Scale as a T0-only moderator rather than a T2 secondary outcome. The SAP supersedes Section 10 of the Study Protocol version 2 (February 21, 2026); where the two conflict, the SAP governs.
Therapy Delivery Staff Seven trained Painhunting therapists deliver treatment. Therapist assignment is tracked as a variable and modeled as a random effect in supplementary mixed-effects analyses.
- Being tested
- Painhunting Therapy
- Keywords
- Painhunting Therapy, Interpersonal Loss, Depression, Complicated Grief, Psychotherapy, Emotional Trauma, Randomized Controlled Trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Painhunting TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Secondary outcomes (5)
Change in GAD-7 Score (Anxiety)
Change in Generalized Anxiety Disorder-7 (GAD-7) Score Self-report measure of anxiety severity (range 0-21). Higher scores indicate more severe anxiety. Analyzed using ANCOVA adjusted for T0 covariate and language preference.
Measured: Time Frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Change in ICG (Inventory of Complicated Grief) Score
Self-report measure of complicated grief symptoms (range 0-76). Scores of 25 or higher indicate clinically significant complicated grief. Analyzed using ANCOVA adjusted for T0 covariate and language preference.
Measured: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Change in WHO-DAS 2.0 12-Item Score (Functional Disability)
Change in World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0) 12-item Score Measure of functional disability (range 12-60). Higher scores indicate greater disability. Analyzed using ANCOVA adjusted for T0 covariate and language preference.
Measured: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Maintenance of Treatment Gains in PHQ-9 and ICG Scores
Maintenance of treatment gains as measured by change in Patient Health Questionnaire-9 (PHQ-9) and Inventory of Complicated Grief (ICG) scores from post-treatment (T2) to 3-month follow-up (T3).
PHQ-9 is a self-report measure of depression severity (range 0-27), with higher scores indicating more severe depression.
ICG is a self-report measure of complicated grief symptoms (range 0-76), with higher scores indicating more severe grief.
Measured: Post-treatment (T2) to 3-month follow-up (T3, approximately week 16)
GIC (Global Impression of Change) at T2
Single-item measure of overall perceived change since study enrollment, rated on a 7-point scale (1 = very much improved to 7 = very much worse). Administered in two parallel versions: participant self-report and independent therapist rating, completed before viewing participant response. Analyzed descriptively with ordinal regression.
Measured: 2 weeks post-randomization (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start23 Mar 2026
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss-Related DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Painhunting LLP
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzakova Sanemkhan, Painhunting LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490691
- Sponsor's protocol ID
- PH-GRIEF-RCT1-2026-WL
- Acronym
- PH-GRIEF
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon acceptance of the primary publication, the de-identified analytic dataset, analysis scripts, and Statistical Analysis Plan will be deposited on the Open Science Framework (OSF) under the existing project record for this trial, subject to participant consent and al-Farabi KazNU LEC requirements. A data dictionary will accompany the dataset. Any restrictions will be noted explicitly at the time of deposit.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Painhunting Therapy for Event-Related Depression: A Waitlist-Controlled Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT07490691
- Acronym / sponsor ID
- PH-GRIEF / PH-GRIEF-RCT1-2026-WL
- Keywords
- Painhunting Therapy, Interpersonal Loss, Depression, Complicated Grief, Psychotherapy, Emotional Trauma, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Painhunting LLPUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 6 Jun 2026 (actual)
- Study completion
- 6 Jun 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Approved by the Local Ethics Committee of al-Farabi Kazakh National University (IRB00010790; Protocol No. IRB-1970), initial approval dated March 5, 2026 (reference №210). Amendments approved: March 12, 2026 letter №213/2 (Amendment 1, protocol title change); April 2, 2026 letter №217 (Amendments 2 and 3 bundled, documentation items and LTE broadening with ICG repositioning); April 9, 2026 letter №218 (Amendment 4, timeline and GIC addition). Approval valid through March 4, 2027.
Screening funnel: 216 applications received; 146 completed screening questionnaire; 122 passed psychometric screening; 84 passed clinical interview and confirmed participation; 84 randomized.
Randomization: 42 to Group A (immediate treatment); 42 to Group B (waitlist). Group A post-randomization disposition: 40 in active therapy; 1 withdrew due to therapist preference; 1 lost to follow-up before first treatment session.
Group B post-randomization disposition: 34 in active waitlist; 1 withdrew due to disclosed concurrent external psychotherapy; 4 lost to follow-up; 3 declined continuation, payment-related.
Intention-to-treat population: all 84 randomized participants, regardless of post-randomization disposition.
Protocol Deviations and Quality Assurance Two methodological issues surfaced during T2 data collection have been addressed analytically and documented here for transparency.
Invalid-assessment retest rule: One Group B participant's first T2 PHQ-9 administration yielded a score that the participant retrospectively attributed to an acute transient mood state unrepresentative of the instrument's two-week recall window. Per SAP Section 10, developed in response to this case and locked prospectively before further T2 data examination, such cases trigger a standardized retest within 24 to 48 hours. The retest score supersedes the original for primary analysis. The original is retained in the dataset with an invalidity flag and enters sensitivity analysis. This rule is bilateral (either arm, either direction of implied bias) and is invoked by the study coordinator.
Concurrent training program exposure: One Group B participant was identified as concurrently attending a Painhunting training program, a potential co-intervention. An audit of all 74 active participants for concurrent or prior Painhunting training, workshop, reading-group, or educational program exposure is being conducted. Any documented exposure is retained in the intention-to-treat population and excluded from the per-protocol secondary analysis. A concurrent-training exclusion criterion has been added (Exclusion Criterion 5 above) and will be applied at screening in any subsequent trial.
Statistical Analysis Plan Availability The Statistical Analysis Plan (SAP version 1.1, dated April 16, 2026) is preregistered on the Open Science Framework (OSF) for this project. The SAP was finalized prior to examination of any between-group Time 2 outcome data. SAP v1.1 differs from v1.0 only in reclassifying the General Self-Efficacy Scale as a T0-only moderator rather than a T2 secondary outcome. The SAP supersedes Section 10 of the Study Protocol version 2 (February 21, 2026); where the two conflict, the SAP governs.
Therapy Delivery Staff Seven trained Painhunting therapists deliver treatment. Therapist assignment is tracked as a variable and modeled as a random effect in supplementary mixed-effects analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental - Painhunting Therapy | Experimental | Behavioral: Painhunting TherapyPainhunting 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Painhunting TherapyPainhunting 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. | Behavioural | Experimental - Painhunting Therapy |
Primary outcome
Change in PHQ-9 (Patient Health Questionnaire-9) Score
Time frame: 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
5 secondary outcomes
Change in GAD-7 Score (Anxiety)
Time frame: Time Frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Change in ICG (Inventory of Complicated Grief) Score
Time frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Change in WHO-DAS 2.0 12-Item Score (Functional Disability)
Time frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)
Maintenance of Treatment Gains in PHQ-9 and ICG Scores
Time frame: Post-treatment (T2) to 3-month follow-up (T3, approximately week 16)
GIC (Global Impression of Change) at T2
Time frame: 2 weeks post-randomization (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Statistical Analysis Plan (SAP v1.1) and preregistration materialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon acceptance of the primary publication, the de-identified analytic dataset, analysis scripts, and Statistical Analysis Plan will be deposited on the Open Science Framework (OSF) under the existing project record for this trial, subject to participant consent and al-Farabi KazNU LEC requirements. A data dictionary will accompany the dataset. Any restrictions will be noted explicitly at the time of deposit.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Painhunting Therapy in people with Loss-Related Depression and Interpersonal Loss, run by Painhunting LLP at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PHQ-9 (Patient Health Questionnaire-9) Score (time frame: Baseline (T0) to post-treatment/end of wait (T2, approximately week 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.