Clinical trial NCT02938559: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2016-10-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Remission
timeFrame: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
measure: Relapse at 6 Months
timeFrame: 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
measure: Relapse at 12 Months
timeFrame: 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
measure: Functional Impairment
timeFrame: 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
measure: Patient Memory for Treatment
timeFrame: 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
measure: Generalization Task
timeFrame: 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
measure: Declarative Memory
timeFrame: 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
measure: Working Memory
timeFrame: 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
measure: Memory Support
timeFrame: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
Secondary outcomes:
measure: Response to Treatment
timeFrame: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
measure: Magnitude of symptom change is operationalized as change on IDS-SR
timeFrame: Change from Pretreatment to Post-Treatment
measure: Recovery
timeFrame: 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
measure: Recurrence
timeFrame: 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
measure: Time to relapse or recurrence
timeFrame: 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
measure: Functional Impairment
timeFrame: 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
measure: Patient Memory for Treatment
timeFrame: 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
measure: Working Memory
timeFrame: 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
measure: Memory Support
timeFrame: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
measure: Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)
timeFrame: 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 outcomes:
measure: Pre-Treatment Assessment Telephone Screen to determine Eligibility
timeFrame: Pre-Treatment
measure: Structure Clinical Interview for DSM-5 (SCID)
timeFrame: 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
measure: Quick Inventory for Depressive Symptomatology-Self-Report (QIDS)
timeFrame: At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
measure: IQ National Adult Reading Test (NART)
timeFrame: Pre-Treatment
measure: Treatment Provider Recall Task
timeFrame: Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
measure: Medication (medication type and dosage)
timeFrame: 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.
measure: Other Treatment/Therapy Tracking Log (presence/absence)
timeFrame: 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.
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
measure: Patient usefulness and utilization of cognitive therapy skills scale (Exploratory)
timeFrame: 2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
measure: Patient Conceptualization of Depression Task (Exploratory)
timeFrame: pre-treatment, post-treatment, 6-month follow-up
measure: Treatment Adherence Rating Scale-Therapist Version
timeFrame: After each treatment session filled out by therapist (20-26 times)
measure: Memory Support Treatment Provider Checklist
timeFrame: After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
measure: Memory Support Rating Scale
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
References:
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.