Меню
Набор скоро начнётся NCT07456410

Development and Validation of Psycho-Social Program (PSP)

Без фазы С лечением Mental Health Issue Depression Diabetes Distress Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psycho-Social Program.
Кому может быть актуально
Состояния в реестре: Mental Health Issue, Depression, Diabetes Distress, Quality of Life. Базовые параметры: 30 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial

Обзор

The study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The intervention is designed to reduce symptoms of depression, anxiety, and diabetes-related distress (DD) by addressing maladaptive thoughts, emotional responses, and coping behaviors associated with chronic illness management. Through structured sessions incorporating cognitive restructuring, stress management techniques, behavioral activation, and adaptive coping strategies, participants will learn to manage emotional distress more effectively while improving treatment adherence and daily functioning. The intervention is expected to enhance psychological well-being, promote healthier coping mechanisms, and support better overall adjustment to living with T2DM.

Подробное описание

This study aims to evaluate the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM.) A total of 80 participants, aged 30-40 years, will be recruited from academic and clinical settings in Faisalabad, Pakistan, using purposive sampling. Participants will be randomly assigned to two groups: the intervention group (n=40) will receive 6-8 sessions of the psycho-social program targeting depression, anxiety, diabetes-related distress, medication adherence and quality of life, while the control group (n=40) will receive standard care without the intervention.

Participants with mild-to-moderate psychological distress will be included, whereas those with severe psychiatric conditions, co-morbidities, or under psychiatric medication will be excluded. Pre- and post-intervention assessments using validated instruments will measure changes in mental health outcomes, coping skills, and overall quality of life. The study is expected to show that the psycho-social program reduces psychological distress, enhances adaptive coping, and improves well-being, providing evidence-based guidance for mental health support in Type 2 diabetes patients.

Вмешательства

  • Поведенческое Psycho-Social Program
    Participants in the intervention group will receive 6-8 sessions of psycho-social program (PSP) designed to improve mental health outcomes in patients with Type 2 diabetes. The session-wise agenda includes: Session 1 - Psychoeducation about diabetes and mental health; Session 2 - Behavioral Activation to increase engagement in health-promoting activities; Session 3 - Cognitive Conceptualization and Restructuring to identify and challenge negative thoughts; Session 4 - Stress Management; Session

Первичные конечные точки

  • Diabetes Distress Scale [Срок оценки: At pre-assessment, after five weeks at post assessment]
  • Patient Health Questionnaire [Срок оценки: At pre-assessment, after five weeks at post assessment]
Вторичные конечные точки (5)
  • Short Health Anxiety Inventory [Срок оценки: At pre-assessment, after five weeks at post assessment]
  • Revised Version of Diabetes Quality of Life Questionnaire [Срок оценки: At pre-assessment, after five weeks at post assessment]
  • Multidimensional Scale of Perceived Social Support [Срок оценки: At pre-assessment, after five weeks at post assessment]
  • Diabetes Stigma Assessment Scale [Срок оценки: At pre-assessment, after five weeks at post assessment]
  • Hill-Bone Medication Adherence Scale (HB-MAS) [Срок оценки: At pre-assessment, after five weeks at post assessment]

Критерии участия

Inclusion Criteria: Participants must be adults aged 30-40 years with Type 2 diabetes, experiencing mild-to-moderate mental health problems related to diabetes will be eligible.

Exclusion Criteria: Participants will be excluded if they have severe psychiatric disorders, serious medical comorbidities, are taking psychiatric medications that may affect outcomes, or are unable to participate in the intervention sessions.

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Пакистан · 1 центр
  • Government College University Faisalabad — Faisalabad

Идентификаторы

NCT: NCT07456410 · GCUF-PSPT2DM-2026 · Ethical Review Committee GCUF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗