Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
28 января 2021 г. обновлено: Allison Harvey, University of California, Berkeley
The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes in major depressive disorder (MDD) and cognitive therapy (CT).
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
Background. Major depressive disorder (MDD) is one of the most prevalent psychiatric disorders and a leading cause of disability worldwide. Existing therapies fail to produce complete recovery. Progress toward improving outcome must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination). The proposed research seeks to test one such innovation. The investigators seek to improve outcome by improving memory for the content of cognitive therapy (CT) sessions. CT is one of the most promising approaches to the treatment of MDD, yet there is room for improvement.
It is proposed that adding memory enhancing strategies to CT may improve MDD outcome because: (a) MDD is often characterized by memory impairment, (b) there is evidence that the memory impairment is modifiable, (c) CT typically entails the activation of emotion, (d) emotion can impair or bias memory and (e) there is evidence that memory for the content of therapy sessions is poor.
Hence, the overall goal is to evaluate if integrating strategies designed to enhance memory for the content of CT sessions improves treatment outcome for MDD. Cognitive support involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory. It is hypothesized that CT+Memory Support, relative to CT-as-usual, will be associated with improved illness course and functional outcome at the end of treatment as well as 6 and 12 months post-treatment.
Тип исследования
Интервенционный
Регистрация (Действительный)
178
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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California
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Berkeley, California, Соединенные Штаты, 94720-1650
- University of California, Berkeley
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Age 18+ years
- Willing and able to give full consent
- English language fluency
- Diagnosis of major depressive disorder (MDD), first episode, recurrent or chronic, according to DSM-5
- Minimum score 26 or above on the Inventory of Depressive Symptomatology, Self-Report (IDS-SR). This cutoff denotes at least 'moderate' depression
- If taking medications for mood, medications must be stable for the past four weeks
Exclusion Criteria:
- History of Bipolar Disorder
- History of Psychosis or psychotic features
- Lifetime history of failure to respond to 4 or more sessions of CBT/CT for depression
- Current non-psychotic disorder if it constitutes the principal diagnosis and if it requires treatment other than that offered in the project. 'Principal' is defined as the disorder currently most distressing and disabling, using a widely accepted severity rating scale capturing distress and interference (0-8, 4+ indicates clinical severity)
- Moderate or severe substance use in the past 6 months where 'moderate' is defined as 4-5 symptoms and 'severe' is defined as 6+ listed in DSM-5 for each of the substance-related disorders
- Evidence of any medical disorder or condition that could cause depression, preclude participation in CT, or is associated with memory problems, that is not currently stabilized and/or managed under the care of a physician or the presence of an active and progressive physical illness or neurological degenerative disease,
- Current suicide risk sufficient to preclude treatment on an outpatient basis (assessed by the Columbia-Suicide Severity Rating Scale) or current homicide risk (assessed by our staff, a case manager or psychiatrist)
- Pregnancy or breastfeeding
- Not able/willing to participate in and/or complete the pre-treatment assessments
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Cognitive Therapy plus Memory Support
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The Memory Support Intervention will be delivered interwoven with CT.
The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory.
It is comprised of eight memory promoting strategies: attention recruitment, categorization, evaluation, application, repetition, practice remembering, cued-based reminder and praise recall.
These strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding.
Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
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Активный компаратор: Cognitive Therapy-as-usual
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There is evidence that CT for major depressive disorder (MDD) can be as effective as antidepressant medication for the initial treatment of moderate to severe MDD.
Moreover, following the withdrawal of treatment, patients treated with CT are significantly less likely to relapse than patients treated with antidepressant medication and CT is at least as effective as antidepressant medication in preventing subsequent relapse.
CT aims to alter the symptomatic expression of depression and reduce risk for subsequent episodes by correcting the negative beliefs and maladaptive information processing presumed to underlie the disorder and alter the systematic tendency to misperceive reality in a pessimistic fashion.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Remission
Временное ограничение: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
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% Remission is defined as signs and symptoms must be absent or close to it for >=3 weeks and operationalized as IDS-SR less than 14.
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Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
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Relapse at 6 Months
Временное ограничение: Calculated at 6-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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% Relapse is defined as 'return to an MDE following remission' and operationalized as greater than or equal to 14 on the IDS-SR at follow-up for those who had remitted.
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Calculated at 6-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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Relapse at 12 Months
Временное ограничение: Calculated at 12 months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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% Relapse is defined as 'return to an MDE following remission' and operationalized as greater than or equal to 14 on the IDS-SR at follow-up for those who had remitted.
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Calculated at 12 months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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Functional Impairment
Временное ограничение: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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WHODAS 2.0 total score
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Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Patient Memory for Treatment
Временное ограничение: Week 4, Week 8, Week 12, Week 16 of treatment as well as Post Treatment, defined as two post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Cumulative Recall on the Patient Treatment Recall Task
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Week 4, Week 8, Week 12, Week 16 of treatment as well as Post Treatment, defined as two post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Generalization Task
Временное ограничение: Week 4, Week 8, Week 12, and Week 16 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Week 4, Week 8, Week 12, and Week 16 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Declarative Memory
Временное ограничение: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Hit Rate minus False Alarm Rate minus Lure Rate on the Episodic Face-Name Learning Task
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Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Working Memory
Временное ограничение: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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No. of correct hits minus the no. of false positives on 3-Back of the N-Back
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Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Memory Support
Временное ограничение: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
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Total Amount on the Memory Support Rating Scale on randomly selected therapy tapes.
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20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Response to Treatment
Временное ограничение: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
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% Response is defined as a clinically significant degree of symptom reduction and operationalized as 50% reduction in pre-treatment symptom severity on the IDS-SR.
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Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
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Magnitude of symptom change is operationalized as change on IDS-SR
Временное ограничение: Change from Pretreatment to Post-Treatment
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Change from Pretreatment to Post-Treatment
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Recovery
Временное ограничение: Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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% Recovery is defined as 'remission sustained for >=4 months' and is operationalized via the LIFE.
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Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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Recurrence
Временное ограничение: Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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% Recurrence is defined as 'return to an MDE following recovery' and is established using the SCID.
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Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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Time to relapse or recurrence
Временное ограничение: Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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Time to relapse or recurrence following response or remission will be established using the SCID.
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Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
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Functional Impairment
Временное ограничение: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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4-question Healthy Days core module
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Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Patient Memory for Treatment
Временное ограничение: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Past Session Recall on the Patient Treatment Recall Task
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Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Working Memory
Временное ограничение: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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No. of correct hits minus the no. of false positives on 0-Back, 1-Back, 2-Back of the N-Back
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Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
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Memory Support
Временное ограничение: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
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Number of Types on the Memory Support Rating Scale
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20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
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Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)
Временное ограничение: Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
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Measure of patient competence at using cognitive therapy skills.
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Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Pre-Treatment Assessment Telephone Screen to determine Eligibility
Временное ограничение: Pre-Treatment
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Pre-Treatment
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Structure Clinical Interview for DSM-5 (SCID)
Временное ограничение: Pre-Treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
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Pre-Treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
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Quick Inventory for Depressive Symptomatology-Self-Report (QIDS)
Временное ограничение: At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
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At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
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IQ National Adult Reading Test (NART)
Временное ограничение: Pre-Treatment
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Pre-Treatment
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Treatment Provider Recall Task
Временное ограничение: Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
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Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
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Medication (medication type and dosage)
Временное ограничение: Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
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Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
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Other Treatment/Therapy Tracking Log (presence/absence)
Временное ограничение: Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
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Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
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Credibility/Expectancy Questionnaire (CEQ)
Временное ограничение: Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
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Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
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Patient usefulness and utilization of cognitive therapy skills scale (Exploratory)
Временное ограничение: 2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
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Measure completed by patients indicating how useful they found specific cognitive therapy skills, and how often they used each skill.
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2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
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Patient Conceptualization of Depression Task (Exploratory)
Временное ограничение: pre-treatment, post-treatment, 6-month follow-up
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pre-treatment, post-treatment, 6-month follow-up
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Treatment Adherence Rating Scale-Therapist Version
Временное ограничение: After each treatment session filled out by therapist (20-26 times)
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After each treatment session filled out by therapist (20-26 times)
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Memory Support Treatment Provider Checklist
Временное ограничение: After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
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After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
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Memory Support Rating Scale
Временное ограничение: Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
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Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 ноября 2016 г.
Первичное завершение (Действительный)
5 августа 2020 г.
Завершение исследования (Действительный)
5 августа 2020 г.
Даты регистрации исследования
Первый отправленный
6 октября 2016 г.
Впервые представлено, что соответствует критериям контроля качества
17 октября 2016 г.
Первый опубликованный (Оценивать)
19 октября 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
2 февраля 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 января 2021 г.
Последняя проверка
1 января 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- R01MH108657 (Грант/контракт NIH США)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Депрессивное расстройство, майор
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National Institute of Allergy and Infectious Diseases...ЗавершенныйVariola Major (оспа)Соединенные Штаты
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