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Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?

28. ledna 2021 aktualizováno: 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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

178

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • Berkeley, California, Spojené státy, 94720-1650
        • University of California, Berkeley

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Cognitive Therapy plus Memory Support
Behaviorální: Cognitive Therapy (CT) for depression + Memory Support
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.
Aktivní komparátor: Cognitive Therapy-as-usual
Behaviorální: Cognitive Therapy (CT) for depression
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Remission
Časové okno: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
% 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.
Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
Relapse at 6 Months
Časové okno: 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
% 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.
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
Relapse at 12 Months
Časové okno: 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
% 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.
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
Functional Impairment
Časové okno: 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
WHODAS 2.0 total score
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
Patient Memory for Treatment
Časové okno: 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
Cumulative Recall on the Patient Treatment Recall Task
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
Generalization Task
Časové okno: 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
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
Declarative Memory
Časové okno: 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
Hit Rate minus False Alarm Rate minus Lure Rate on the Episodic Face-Name Learning Task
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
Working Memory
Časové okno: 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
No. of correct hits minus the no. of false positives on 3-Back of the N-Back
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
Memory Support
Časové okno: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
Total Amount on the Memory Support Rating Scale on randomly selected therapy tapes.
20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Response to Treatment
Časové okno: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
% 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.
Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
Magnitude of symptom change is operationalized as change on IDS-SR
Časové okno: Change from Pretreatment to Post-Treatment
Change from Pretreatment to Post-Treatment
Recovery
Časové okno: 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
% Recovery is defined as 'remission sustained for >=4 months' and is operationalized via the LIFE.
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
Recurrence
Časové okno: 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
% Recurrence is defined as 'return to an MDE following recovery' and is established using the SCID.
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
Time to relapse or recurrence
Časové okno: 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
Time to relapse or recurrence following response or remission will be established using the SCID.
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
Functional Impairment
Časové okno: 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
4-question Healthy Days core module
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
Patient Memory for Treatment
Časové okno: 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
Past Session Recall on the Patient Treatment Recall Task
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
Working Memory
Časové okno: 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
No. of correct hits minus the no. of false positives on 0-Back, 1-Back, 2-Back of the N-Back
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
Memory Support
Časové okno: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
Number of Types on the Memory Support Rating Scale
20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)
Časové okno: 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
Measure of patient competence at using cognitive therapy skills.
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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pre-Treatment Assessment Telephone Screen to determine Eligibility
Časové okno: Pre-Treatment
Pre-Treatment
Structure Clinical Interview for DSM-5 (SCID)
Časové okno: 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
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
Quick Inventory for Depressive Symptomatology-Self-Report (QIDS)
Časové okno: At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
IQ National Adult Reading Test (NART)
Časové okno: Pre-Treatment
Pre-Treatment
Treatment Provider Recall Task
Časové okno: Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
Medication (medication type and dosage)
Časové okno: 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.
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.
Other Treatment/Therapy Tracking Log (presence/absence)
Časové okno: 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.
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.
Credibility/Expectancy Questionnaire (CEQ)
Časové okno: Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
Patient usefulness and utilization of cognitive therapy skills scale (Exploratory)
Časové okno: 2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
Measure completed by patients indicating how useful they found specific cognitive therapy skills, and how often they used each skill.
2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
Patient Conceptualization of Depression Task (Exploratory)
Časové okno: pre-treatment, post-treatment, 6-month follow-up
pre-treatment, post-treatment, 6-month follow-up
Treatment Adherence Rating Scale-Therapist Version
Časové okno: After each treatment session filled out by therapist (20-26 times)
After each treatment session filled out by therapist (20-26 times)
Memory Support Treatment Provider Checklist
Časové okno: After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
Memory Support Rating Scale
Časové okno: Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
Week 1, Week 4, Week 8, Week 12, Week 16 of treatment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of California, Berkeley

Spolupracovníci

Vanderbilt University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2016

Primární dokončení (Aktuální)

5. srpna 2020

Dokončení studie (Aktuální)

5. srpna 2020

Termíny zápisu do studia

První předloženo

6. října 2016

První předloženo, které splnilo kritéria kontroly kvality

17. října 2016

První zveřejněno (Odhad)

19. října 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. února 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. ledna 2021

Naposledy ověřeno

1. ledna 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • R01MH108657 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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