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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Central Painhunting Office
Astana, Astana, Kazakhstan
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.
Time frame: 6 weeks post-randomization
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.
Time frame: 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.
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)
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 10 to 12 weeks post-randomization
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