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

NCT02938559 | Completed DMC

• 1 other identifier: R01MH108657
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (10)

• Response to Treatment

  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

  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

  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

  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

Other Outcomes (13)

• Pre-Treatment Assessment Telephone Screen to determine Eligibility

  Pre-Treatment

• Structure Clinical Interview for DSM-5 (SCID)

  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)

  At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)

Study Arms (2)

Cognitive Therapy plus Memory Support

EXPERIMENTAL

Behavioral: Cognitive Therapy (CT) for depression + Memory Support

Cognitive Therapy-as-usual

ACTIVE COMPARATOR

Behavioral: Cognitive Therapy (CT) for depression

Interventions

Cognitive Therapy (CT) for depression BEHAVIORAL

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.

Cognitive Therapy-as-usual

Cognitive Therapy (CT) for depression + Memory Support BEHAVIORAL

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.

Cognitive Therapy plus Memory Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• Vanderbilt University: collaborator

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720-1650, United States

Location

Related Publications (2)

• Sarfan LD, Zieve G, Gumport NB, Xiong M, Harvey AG. Optimizing outcomes, mechanisms, and recall of Cognitive Therapy for depression: Dose of constructive memory support strategies. Behav Res Ther. 2023 Jul;166:104325. doi: 10.1016/j.brat.2023.104325. Epub 2023 May 13.

  PMID: 37210887 DERIVED

• 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.

  PMID: 34134832 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology,

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 19, 2016
• Study Start: November 1, 2016
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

US (1)