Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 178
- Locations
- 2
- Primary Endpoint
- Remission
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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 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: 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
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
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.
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
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.
Secondary Outcomes
- Time to relapse or recurrence(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)
- Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)(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)
- Response to Treatment(Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview))
- Patient Memory for Treatment(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)
- Recurrence(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(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(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(20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview)
- Magnitude of symptom change is operationalized as change on IDS-SR(Change from Pretreatment to Post-Treatment)
- Working Memory(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)
Investigators
Allison Harvey
Professor of Clinical Psychology,
University of California, Berkeley