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

28 gennaio 2021 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

178

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Berkeley, California, Stati Uniti, 94720-1650
        • University of California, Berkeley

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cognitive Therapy plus Memory Support
Comportamentale: 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.
Comparatore attivo: Cognitive Therapy-as-usual
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Remission
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response to Treatment
Lasso di tempo: 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
Lasso di tempo: Change from Pretreatment to Post-Treatment
Change from Pretreatment to Post-Treatment
Recovery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pre-Treatment Assessment Telephone Screen to determine Eligibility
Lasso di tempo: Pre-Treatment
Pre-Treatment
Structure Clinical Interview for DSM-5 (SCID)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Pre-Treatment
Pre-Treatment
Treatment Provider Recall Task
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: pre-treatment, post-treatment, 6-month follow-up
pre-treatment, post-treatment, 6-month follow-up
Treatment Adherence Rating Scale-Therapist Version
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
Week 1, Week 4, Week 8, Week 12, Week 16 of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, Berkeley

Collaboratori

Vanderbilt University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2016

Completamento primario (Effettivo)

5 agosto 2020

Completamento dello studio (Effettivo)

5 agosto 2020

Date di iscrizione allo studio

Primo inviato

6 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

17 ottobre 2016

Primo Inserito (Stima)

19 ottobre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 febbraio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R01MH108657 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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