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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Cognitive Therapy (CT) for depression
* Behavioral: Cognitive Therapy (CT) for depression + Memory Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Therapy plus Memory Support<br> | Behavioral: Cognitive Therapy (CT) for depression + Memory Support<br>* 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.<br>|
| Active Comparator: Cognitive Therapy-as-usual<br> | Behavioral: Cognitive Therapy (CT) for depression<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview) | 
| 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. | 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 | % 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 | 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 | 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 |  | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 |  | Change from Pretreatment to Post-Treatment | 
| Recovery | % 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 | % 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 | 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 | 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 | 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 | 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 | 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) | 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 |