Depression - Major Depressive Disorder
Conditions
Keywords
painhunting, painhunting therapy, CBT, event-related depression, depression, psychotherapy, Cognitive Behavioral Therapy, Depressive Symptoms
Brief 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. 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.
Interventions
BEHAVIORALPainhunting Therapy
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.
BEHAVIORALCognitive 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.
Sponsors
Painhunting LLP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors administering assessments at T2, T3, and T4 are blinded to treatment allocation. Participants and treating therapists are not blinded due to the nature of the psychotherapeutic interventions. Statistical analyses are performed using blinded group coding until the primary analysis is locked.
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) | 2 weeks and 10 to 12 weeks post-randomization | 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. |
| Anxiety symptom severity measured by the Generalized Anxiety Disorder-7 (GAD-7) | Baseline, 2 weeks, 6 weeks, and 10 to 12 weeks post-randomization | 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. |
| Event-related distress measured by the Impact of Event Scale-Revised (IES-R) | Baseline, 6 weeks, and 10 to 12 weeks post-randomization | 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. |
| Complicated grief symptoms measured by the Inventory of Complicated Grief (ICG) | Baseline, 6 weeks, and 10 to 12 weeks post-randomization | 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. |
| Functional impairment measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHO-DAS 2.0) | Baseline, 6 weeks, and 10 to 12 weeks post-randomization | 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. |
| Treatment response based on PHQ-9 | 6 weeks and 10 to 12 weeks post-randomization | 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. |
| Remission based on PHQ-9 | 6 weeks and 10 to 12 weeks post-randomization | Remission is defined as a PHQ-9 score below 5. The proportion of participants meeting the remission criterion will be assessed by treatment arm. |
| Number of treatment sessions received | From treatment initiation through completion of the active treatment period, approximately 4 weeks | The total number of treatment sessions received by each participant during the active treatment period will be recorded and summarized by treatment arm. |
| Treatment and study dropout rate | Through 10 to 12 weeks post-randomization | The proportion of participants who discontinue treatment or study participation will be recorded and summarized by treatment arm and assessment timepoint. |
| Protocol deviation rate | Through 10 to 12 weeks post-randomization | The number and proportion of participants with documented protocol deviations will be summarized by treatment arm. |
Countries
Kazakhstan
Contacts
CONTACTolzhas seitov, MSc
CONTACTSanemkhan Uzakova, MSc, MD
Outcome results
None listed