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

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ClinicalTrials.gov Identifier: NCT02938559
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Allison Harvey, University of California, Berkeley

Tracking Information
First Submitted Date  ICMJE October 6, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date June 14, 2018
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Remission [ Time Frame: 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 or equal to 14.
  • Relapse at 6 Months [ Time Frame: 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.
  • Relapse at 12 Months [ Time Frame: 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.
  • Functional Impairment [ Time Frame: 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
  • Patient Memory for Treatment [ Time Frame: 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
  • Generalization Task [ Time Frame: 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 [ Time Frame: 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
  • Working Memory [ Time Frame: 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
  • Memory Support [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Remission [ Time Frame: 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 or equal to 14.
  • Relapse at 6 Months [ Time Frame: 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.
  • Functional Impairment [ Time Frame: 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
  • Patient Memory for Treatment [ Time Frame: 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 ]
    Cumulative Recall on the Patient Treatment Recall Task
  • Generalization Task [ Time Frame: 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 ]
  • Declarative Memory [ Time Frame: 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
  • Working Memory [ Time Frame: 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
  • Memory Support [ Time Frame: 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.
  • Relapse at 12 Months [ Time Frame: 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.
Change History Complete list of historical versions of study NCT02938559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • Response to Treatment [ Time Frame: 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.
  • Magnitude of symptom change is operationalized as change on IDS-SR [ Time Frame: Change from Pretreatment to Post-Treatment ]
  • Recovery [ Time Frame: 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 SCID and LIFE.
  • Recurrence [ Time Frame: 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 and LIFE.
  • Time to relapse or recurrence [ Time Frame: 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 and LIFE.
  • Functional Impairment [ Time Frame: 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
  • Patient Memory for Treatment [ Time Frame: 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
  • Working Memory [ Time Frame: 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
  • Memory Support [ Time Frame: 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
  • Competencies of Cognitive Therapy Scale (CCTS) (Exploratory) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Response to Treatment [ Time Frame: 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.
  • Magnitude of symptom change is operationalized as change on IDS-SR [ Time Frame: Change from Pretreatment to Post-Treatment ]
  • Recovery [ Time Frame: 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 SCID and LIFE.
  • Recurrence [ Time Frame: 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 and LIFE.
  • Time to relapse or recurrence [ Time Frame: 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 and LIFE.
  • Functional Impairment [ Time Frame: 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
  • Patient Memory for Treatment [ Time Frame: 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
  • Working Memory [ Time Frame: 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
  • Memory Support [ Time Frame: 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
Current Other Pre-specified Outcome Measures
 (submitted: August 17, 2017)
  • Pre-Treatment Assessment Telephone Screen to determine Eligibility [ Time Frame: Pre-Treatment ]
  • Structure Clinical Interview for DSM-5 (SCID) [ Time Frame: 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) [ Time Frame: At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview) ]
  • IQ National Adult Reading Test (NART) [ Time Frame: Pre-Treatment ]
  • Treatment Provider Recall Task [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
  • Patient Conceptualization of Depression Task (Exploratory) [ Time Frame: pre-treatment, post-treatment, 6-month follow-up ]
  • Treatment Adherence Rating Scale-Therapist Version [ Time Frame: After each treatment session filled out by therapist (20-26 times) ]
  • Memory Support Treatment Provider Checklist [ Time Frame: After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times) ]
  • Memory Support Rating Scale [ Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16 of treatment ]
Original Other Pre-specified Outcome Measures
 (submitted: October 17, 2016)
  • Pre-Treatment Assessment Telephone Screen to determine Eligibility [ Time Frame: Pre-Treatment ]
  • Structure Clinical Interview for DSM-5 (SCID) [ Time Frame: 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) [ Time Frame: At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview) ]
  • IQ National Adult Reading Test (NART) [ Time Frame: 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 ]
  • Treatment Provider Recall Task [ Time Frame: Week 4, Week 8, and Week 12 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), 6 month Follow-Up, 12 month Follow-Up ]
  • Medication (medication type and dosage) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Treatment Week 2 and 2 weeks Post-Treatment ]
 
Descriptive Information
Brief Title  ICMJE Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
Official Title  ICMJE Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
Brief Summary 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).
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Cognitive Therapy plus Memory Support
    Intervention: Behavioral: Cognitive Therapy (CT) for depression + Memory Support
  • Active Comparator: Cognitive Therapy-as-usual
    Intervention: Behavioral: Cognitive Therapy (CT) for depression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
178
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Allison G. Harvey, Ph.D. + 1-510-642-7138 aharvey@berkeley.edu
Contact: Alice Mullin (510) 643-3797 alicemullin@berkeley.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938559
Other Study ID Numbers  ICMJE R01MH108657( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allison Harvey, University of California, Berkeley
Study Sponsor  ICMJE University of California, Berkeley
Collaborators  ICMJE Vanderbilt University
Investigators  ICMJE Not Provided
PRS Account University of California, Berkeley
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP