Back to resultsCan the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy (CT) for depression
Cognitive Therapy (CT) for depression + Memory Support
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
Eligibility Criteria
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
Sites / Locations
- University of California, Berkeley
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Therapy plus Memory Support
Cognitive Therapy-as-usual
Arm Description
Outcomes
Primary Outcome Measures
Remission
% 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.
Relapse at 6 Months
% 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
% 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
WHODAS 2.0 total score
Patient Memory for Treatment
Cumulative Recall on the Patient Treatment Recall Task
Generalization Task
Declarative Memory
Hit Rate minus False Alarm Rate minus Lure Rate on the Episodic Face-Name Learning Task
Working Memory
No. of correct hits minus the no. of false positives on 3-Back of the N-Back
Memory Support
Total Amount on the Memory Support Rating Scale on randomly selected therapy tapes.
Secondary Outcome Measures
Response to Treatment
% 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
Recovery
% Recovery is defined as 'remission sustained for >=4 months' and is operationalized via the LIFE.
Recurrence
% Recurrence is defined as 'return to an MDE following recovery' and is established using the SCID.
Time to relapse or recurrence
Time to relapse or recurrence following response or remission will be established using the SCID.
Functional Impairment
4-question Healthy Days core module
Patient Memory for Treatment
Past Session Recall on the Patient Treatment Recall Task
Working Memory
No. of correct hits minus the no. of false positives on 0-Back, 1-Back, 2-Back of the N-Back
Memory Support
Number of Types on the Memory Support Rating Scale
Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)
Measure of patient competence at using cognitive therapy skills.
Full Information
NCT ID
NCT02938559
First Posted
October 6, 2016
Last Updated
January 28, 2021
Sponsor
University of California, Berkeley
Collaborators
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT02938559
Brief Title
Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
Official Title
Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
Collaborators
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Therapy plus Memory Support
Arm Type
Experimental
Arm Title
Cognitive Therapy-as-usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy (CT) for depression
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy (CT) for depression + Memory Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Remission
Description
% 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.
Time Frame
Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
Title
Relapse at 6 Months
Description
% 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.
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
Title
Relapse at 12 Months
Description
% 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.
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
Title
Functional Impairment
Description
WHODAS 2.0 total score
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
Title
Patient Memory for Treatment
Description
Cumulative Recall on the Patient Treatment Recall Task
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
Title
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
Title
Declarative Memory
Description
Hit Rate minus False Alarm Rate minus Lure Rate on the Episodic Face-Name Learning 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
Title
Working Memory
Description
No. of correct hits minus the no. of false positives on 3-Back of the N-Back
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
Title
Memory Support
Description
Total Amount on the Memory Support Rating Scale on randomly selected therapy tapes.
Time Frame
20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
Secondary Outcome Measure Information:
Title
Response to Treatment
Description
% 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.
Time Frame
Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
Title
Magnitude of symptom change is operationalized as change on IDS-SR
Time Frame
Change from Pretreatment to Post-Treatment
Title
Recovery
Description
% Recovery is defined as 'remission sustained for >=4 months' and is operationalized via the LIFE.
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
Title
Recurrence
Description
% Recurrence is defined as 'return to an MDE following recovery' and is established using the SCID.
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
Title
Time to relapse or recurrence
Description
Time to relapse or recurrence following response or remission will be established using the SCID.
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
Title
Functional Impairment
Description
4-question Healthy Days core module
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
Title
Patient Memory for Treatment
Description
Past Session Recall on the Patient Treatment Recall 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
Title
Working Memory
Description
No. of correct hits minus the no. of false positives on 0-Back, 1-Back, 2-Back of the N-Back
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
Title
Memory Support
Description
Number of Types on the Memory Support Rating Scale
Time Frame
20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
Title
Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)
Description
Measure of patient competence at using cognitive therapy skills.
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
Other Pre-specified Outcome Measures:
Title
Pre-Treatment Assessment Telephone Screen to determine Eligibility
Time Frame
Pre-Treatment
Title
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
Title
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)
Title
IQ National Adult Reading Test (NART)
Time Frame
Pre-Treatment
Title
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
Title
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.
Title
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.
Title
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
Title
Patient usefulness and utilization of cognitive therapy skills scale (Exploratory)
Description
Measure completed by patients indicating how useful they found specific cognitive therapy skills, and how often they used each skill.
Time Frame
2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
Title
Patient Conceptualization of Depression Task (Exploratory)
Time Frame
pre-treatment, post-treatment, 6-month follow-up
Title
Treatment Adherence Rating Scale-Therapist Version
Time Frame
After each treatment session filled out by therapist (20-26 times)
Title
Memory Support Treatment Provider Checklist
Time Frame
After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
Title
Memory Support Rating Scale
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34134832
Citation
Gumport NB, Zieve GG, Dong L, Harvey AG. The Development and Validation of the Memory Support Treatment Provider Checklist. Behav Ther. 2021 Jul;52(4):932-944. doi: 10.1016/j.beth.2020.11.005. Epub 2020 Dec 17.
Results Reference
derived
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Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
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