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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938559
• Other study ID #: R01MH108657
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 5, 2020

Study information

• Verified date: January 2021
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-Treatment Assessment Telephone Screen to determine Eligibility		Pre-Treatment
Other	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
Other	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)
Other	IQ National Adult Reading Test (NART)		Pre-Treatment
Other	Treatment Provider Recall Task		Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
Other	Medication (medication type and dosage)		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.
Other	Other Treatment/Therapy Tracking Log (presence/absence)		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.
Other	Credibility/Expectancy Questionnaire (CEQ)		Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
Other	Patient usefulness and utilization of cognitive therapy skills scale (Exploratory)	Measure completed by patients indicating how useful they found specific cognitive therapy skills, and how often they used each skill.	2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
Other	Patient Conceptualization of Depression Task (Exploratory)		pre-treatment, post-treatment, 6-month follow-up
Other	Treatment Adherence Rating Scale-Therapist Version		After each treatment session filled out by therapist (20-26 times)
Other	Memory Support Treatment Provider Checklist		After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
Other	Memory Support Rating Scale		Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	Magnitude of symptom change is operationalized as change on IDS-SR		Change from Pretreatment to Post-Treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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