Depression - Major Depressive DisorderPH-CBTNCT07738146
Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression
A study testing Painhunting Therapy and Cognitive Behavioural Therapy (CBT) in people with Depression - Major Depressive Disorder, run by Painhunting LLP at 1 site in Kazakhstan.
Trial summary
This randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Painhunting Therapy and Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or older.
- PHQ-9 score of 9 or greater at screening.
- At least one adverse life event within the prior 24 months, documented using the Life Events Threshold (LTE) instrument.
- Resident of Kazakhstan.
- Fluent in Russian.
- Capacity to provide written informed consent.
- Willing to attend at least six sessions within the protocol treatment schedule.
Who cannot join
- Active suicidal ideation requiring immediate referral, defined as PHQ-9 item 9 score of 3 or clinical judgment of imminent risk.
- Active psychosis or mania.
- Active substance use disorder meeting DSM criteria.
- Current psychotherapy with another provider.
- Initiation of pharmacotherapy within the prior four weeks.
- Pre-existing stable antidepressant monotherapy unchanged for eight weeks or longer is permitted.
- Inability to provide informed consent in Russian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site
Central Painhunting Office
Astana, Astana, 010000
olzhas seitov, MSc, 87017636166, seitov.ok@gmail.com
About this study
Official title: Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation
This randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. The primary outcome is depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) at six weeks after randomization. Secondary outcomes include anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and durability of outcomes at 10 to 12 weeks. The study will also assess treatment fidelity, therapeutic alliance, and selected potential moderators of treatment response. The trial uses a randomized, rater-blinded, parallel-group design with an adaptive sample-size approach.
Read the detailed description
The purpose of this study is to compare the effectiveness of Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT), an established psychological treatment for depression, in adults experiencing depressive symptoms associated with adverse life events.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The Painhunting Therapy arm will receive a brief structured course of therapy, with a minimum planned dose of three sessions except for participants meeting prespecified early-remission criteria, and additional sessions permitted when clinically indicated. The CBT arm will receive manualized CBT for depression delivered over approximately six to eight sessions. The intended primary treatment comparison is approximately three Painhunting sessions versus six CBT sessions, reflecting the typical delivery format of each intervention rather than a matched-dose comparison.
The primary endpoint is PHQ-9 score at six weeks after randomization. Additional assessments will examine depressive symptoms at earlier and later time points, anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and maintenance of outcomes at 10 to 12 weeks.
Outcome assessments at key follow-up time points will be conducted by assessors blinded to treatment allocation. Treatment adherence and fidelity will be independently assessed in both treatment arms using prespecified treatment-specific rating instruments.
The trial will initially enroll 30 participants, with 15 participants per treatment arm. An interim analysis and prespecified adaptive sample-size procedure will determine continuation toward a planned final analyzed sample of 60 participants, with 30 participants per arm, unless a prespecified stopping criterion is met.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Painhunting Therapy, Cognitive Behavioural Therapy (CBT)
- Keywords
- painhunting, painhunting therapy, CBT, event-related depression, depression, psychotherapy, Cognitive Behavioral Therapy, Depressive Symptoms
- 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 targeting event-related distress through a standardized treatment protocol. The intended treatment dose is three sessions. Early stopping after session 2 is permitted only when prespecified remission criteria are met. Additional sessions, up to a maximum of six, may be provided according to prespecified symptom-based and clinical criteria.
Cognitive Behavioural Therapy (CBT)Behavioural
Manualized Cognitive Behavioural Therapy for depression delivered over 6 to 8 sessions at approximately twice-weekly frequency. Treatment is delivered by independent CBT practitioners who meet prespecified training and competence requirements and are not affiliated with the Painhunting practice or training programme.
| Study group | Role | What they receive |
|---|---|---|
| Painhunting Therapy | Experimental | Participants assigned to this arm will receive Painhunting Therapy, a structured psychotherapeutic intervention. The intended treatment dose is three sessions. Early stopping after session 2 is permitted only when prespecified remission criteria are met. Additional sessions, up to a maximum of six, may be provided according to prespecified symptom-based and clinical criteria. Receives: Behavioral: Painhunting Therapy |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Participants assigned to this arm will receive manualized Cognitive Behavioural Therapy (CBT) for depression, delivered over 6 to 8 sessions at approximately twice-weekly frequency. Treatment will be delivered by independent CBT practitioners who are not affiliated with the Painhunting practice or training programme. Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, each scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms. The primary comparison between treatment groups will evaluate PHQ-9 scores at six weeks post-randomization, adjusting for baseline PHQ-9.
Measured: 6 weeks post-randomization
Secondary outcomes (10)
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms.
Measured: 2 weeks and 10 to 12 weeks post-randomization
Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7)
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). The scale consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.
Measured: Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization
Event-related distress measured by the Impact of Event Scale-Revised (IES-R)
Event-related distress will be assessed using the Impact of Event Scale-Revised (IES-R). The instrument contains 22 items rated from 0 to 4. Higher scores indicate greater severity of event-related distress.
Measured: Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG)
Complicated grief symptoms will be assessed using the Inventory of Complicated Grief (ICG) only among participants in the prespecified bereavement/loss stratum, defined as participants whose qualifying index event is the death of a significant other. Participants outside this stratum will not complete the ICG. Higher scores indicate greater severity of complicated grief symptoms.
Measured: Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Functional impairment measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0)
Functional impairment will be assessed using the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0). Higher scores indicate greater disability and functional impairment.
Measured: Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Treatment response based on PHQ-9
Treatment response is defined as a reduction of 50% or greater in PHQ-9 score from baseline. The proportion of participants meeting the response criterion will be assessed by treatment arm.
Measured: 6 weeks and 10 to 12 weeks post-randomization
Remission based on PHQ-9
Remission is defined as a PHQ-9 score below 5. The proportion of participants meeting the remission criterion will be assessed by treatment arm.
Measured: 6 weeks and 10 to 12 weeks post-randomization
Number of treatment sessions received
The total number of treatment sessions received by each participant during the active treatment period will be recorded and summarized by treatment arm.
Measured: From treatment initiation through completion of the active treatment period, approximately 4 weeks
Treatment and study dropout rate
The proportion of participants who discontinue treatment or study participation will be recorded and summarized by treatment arm and assessment timepoint.
Measured: Through 10 to 12 weeks post-randomization
Protocol deviation rate
The number and proportion of participants with documented protocol deviations will be summarized by treatment arm.
Measured: Through 10 to 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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 are randomized 1:1 to Painhunting Therapy or Cognitive Behavioural Therapy. The trial uses an adaptive design with an initial cohort of 30 participants (15 per arm) and planned continuation to a total analyzed sample of 60 participants (30 per arm), unless a prespecified stopping criterion is met.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT07738146
- Sponsor's protocol ID
- IRB-2167
- Acronym
- PH-CBT
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication, together with analysis scripts, will be made publicly available on the Open Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation
- ClinicalTrials.gov ID
- NCT07738146
- Acronym / sponsor ID
- PH-CBT / IRB-2167
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- painhunting, painhunting therapy, CBT, event-related depression, depression, psychotherapy, Cognitive Behavioral Therapy, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Painhunting LLPUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Jul 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 randomized, active-comparator pilot trial will compare Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT) in adults with event-related depressive symptoms. Participants will be randomly assigned in a 1:1 ratio to receive either Painhunting Therapy or CBT. The primary outcome is depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) at six weeks after randomization. Secondary outcomes include anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and durability of outcomes at 10 to 12 weeks. The study will also assess treatment fidelity, therapeutic alliance, and selected potential moderators of treatment response. The trial uses a randomized, rater-blinded, parallel-group design with an adaptive sample-size approach.
Detailed description
The purpose of this study is to compare the effectiveness of Painhunting Therapy with manualized Cognitive Behavioural Therapy (CBT), an established psychological treatment for depression, in adults experiencing depressive symptoms associated with adverse life events.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The Painhunting Therapy arm will receive a brief structured course of therapy, with a minimum planned dose of three sessions except for participants meeting prespecified early-remission criteria, and additional sessions permitted when clinically indicated. The CBT arm will receive manualized CBT for depression delivered over approximately six to eight sessions. The intended primary treatment comparison is approximately three Painhunting sessions versus six CBT sessions, reflecting the typical delivery format of each intervention rather than a matched-dose comparison.
The primary endpoint is PHQ-9 score at six weeks after randomization. Additional assessments will examine depressive symptoms at earlier and later time points, anxiety symptoms, event-related distress, functional impairment, treatment response and remission, treatment retention, and maintenance of outcomes at 10 to 12 weeks.
Outcome assessments at key follow-up time points will be conducted by assessors blinded to treatment allocation. Treatment adherence and fidelity will be independently assessed in both treatment arms using prespecified treatment-specific rating instruments.
The trial will initially enroll 30 participants, with 15 participants per treatment arm. An interim analysis and prespecified adaptive sample-size procedure will determine continuation toward a planned final analyzed sample of 60 participants, with 30 participants per arm, unless a prespecified stopping criterion is met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to Painhunting Therapy or Cognitive Behavioural Therapy. The trial uses an adaptive design with an initial cohort of 30 participants (15 per arm) and planned continuation to a total analyzed sample of 60 participants (30 per arm), unless a prespecified stopping criterion is met.
| Arm | Type | Receives |
|---|---|---|
| Painhunting Therapy | Experimental | Behavioral: Painhunting TherapyParticipants assigned to this arm will receive Painhunting Therapy, a structured psychotherapeutic intervention. The intended treatment dose is three sessions. Early stopping after session 2 is permitted only when prespecified remission criteria are met. Additional sessions, up to a maximum of six, may be provided according to prespecified symptom-based and clinical criteria. |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioural Therapy (CBT)Participants assigned to this arm will receive manualized Cognitive Behavioural Therapy (CBT) for depression, delivered over 6 to 8 sessions at approximately twice-weekly frequency. Treatment will be delivered by independent CBT practitioners who are not affiliated with the Painhunting practice or training programme. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older.
- PHQ-9 score of 9 or greater at screening.
- At least one adverse life event within the prior 24 months, documented using the Life Events Threshold (LTE) instrument.
- Resident of Kazakhstan.
- Fluent in Russian.
Key exclusion criteria (7 listed)
- Active suicidal ideation requiring immediate referral, defined as PHQ-9 item 9 score of 3 or clinical judgment of imminent risk.
- Active psychosis or mania.
- Active substance use disorder meeting DSM criteria.
- Current psychotherapy with another provider.
- Initiation of pharmacotherapy within the prior four weeks.
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 targeting event-related distress through a standardized treatment protocol. The intended treatment dose is three sessions. Early stopping after session 2 is permitted only when prespecified remission criteria are met. Additional sessions, up to a maximum of six, may be provided according to prespecified symptom-based and clinical criteria. | Behavioural | Painhunting Therapy |
| Cognitive Behavioural Therapy (CBT)Manualized Cognitive Behavioural Therapy for depression delivered over 6 to 8 sessions at approximately twice-weekly frequency. Treatment is delivered by independent CBT practitioners who meet prespecified training and competence requirements and are not affiliated with the Painhunting practice or training programme. | Behavioural | Cognitive Behavioural Therapy (CBT) |
Primary outcome
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 weeks post-randomization
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, each scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms. The primary comparison between treatment groups will evaluate PHQ-9 scores at six weeks post-randomization, adjusting for baseline PHQ-9.
10 secondary outcomes
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 2 weeks and 10 to 12 weeks post-randomization
Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization
Event-related distress measured by the Impact of Event Scale-Revised (IES-R)
Time frame: Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG)
Time frame: Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Functional impairment measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0)
Time frame: Baseline, 6 weeks, and 10 to 12 weeks post-randomization
Treatment response based on PHQ-9
Time frame: 6 weeks and 10 to 12 weeks post-randomization
Remission based on PHQ-9
Time frame: 6 weeks and 10 to 12 weeks post-randomization
Number of treatment sessions received
Time frame: From treatment initiation through completion of the active treatment period, approximately 4 weeks
Treatment and study dropout rate
Time frame: Through 10 to 12 weeks post-randomization
Protocol deviation rate
Time frame: Through 10 to 12 weeks post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication, together with analysis scripts, will be made publicly available on the Open Science Framework (OSF).
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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.
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 and Cognitive Behavioural Therapy (CBT) in people with Depression - Major Depressive Disorder, 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 31 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact olzhas seitov, MSc (+77017636166, seitov.ok@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) (time frame: 6 weeks post-randomization). 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 31 Jul 2026.