Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Therapy plus Memory Support | Experimental |
| |
| Cognitive Therapy-as-usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Berkeley | Berkeley | California | 94720-1650 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41955881 | Derived | Callaway CA, Milner AE, Zieve GG, Ashlock L, Harvey AG. Therapist memory for treatment contents: Implications for patient outcomes. Behav Res Ther. 2026 Jun;201:105037. doi: 10.1016/j.brat.2026.105037. Epub 2026 Apr 6. | |
| 37210887 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| 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 |
| 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) |
| IQ National Adult Reading Test (NART) | Pre-Treatment |
| 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 |
| 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 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. |
| 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 |
| 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 |
| Patient Conceptualization of Depression Task (Exploratory) | pre-treatment, post-treatment, 6-month follow-up |
| Treatment Adherence Rating Scale-Therapist Version | After each treatment session filled out by therapist (20-26 times) |
| Memory Support Treatment Provider Checklist | After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times) |
| Memory Support Rating Scale | Week 1, Week 4, Week 8, Week 12, Week 16 of treatment |
| 34134832 | 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. |