Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Painhunting Therapy, Cognitive Behavioural Therapy (CBT).
- Who it may be relevant to
- Registry conditions: Depression - Major Depressive Disorder. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kazakhstan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Painhunting Therapy Versus Cognitive Behavioural Therapy for Event-Related Depression: Active-Comparator Randomized Pilot Trial With Adaptive Sample-Size Re-Estimation
Overview
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
- Behavioral Painhunting 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. - Behavioral 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.
Primary outcome measures
- Depressive symptom severity measured by the Patient Health Questionnaire-9 (PHQ-9) [Time frame: 6 weeks post-randomization]
Secondary outcome measures (10)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Kazakhstan · 1 center
- Central Painhunting Office — Astana
Identifiers
NCT: NCT07738146 · IRB-2167