Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)
NCT03691402, Not applicable, Completed, Universitätsklinikum Hamburg-Eppendorf
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver) | ClinicalTrials.gov |
| NCT number | NCT03691402 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universitätsklinikum Hamburg-Eppendorf | ClinicalTrials.gov |
| Conditions | Depression | ClinicalTrials.gov |
| Interventions | MCT-Silver, Cognitive Remediation | ClinicalTrials.gov |
| First posted | 2018-10-01 | ClinicalTrials.gov |
| Last updated | 2021-10-19 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HRSD-24) | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | The 24-item version of the Hamilton Depression Rating Scale is an established clinician-rated assessment of depressive symptom severity and assesses psychological as well as somatic symptoms (scores range from 0-2 or 0-4) of depression. The clinician rates the severity of these symptoms based on the patient's report and his or her own observation. Scores range from 0-54. Based on the first 17 items, a score of 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression and scores greater than 23 indicate very severe depression. The scale has demonstrated good sensitivity and specificity among older adults (Mottram, Wilson \& Copeland, 2001). The reliability and validity among older adult samples has also been confirmed (Korner et al., 2006). In terms of assessing change for the current trial, a greater reduction in depressive symptoms (i.e., change score) indicates better outcome. | ClinicalTrials.gov |
| Secondary | 16-item Quick Inventory for Depression (QIDS-C16) | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in rater-assessed depression as measured by the 16-item Quick Inventory for Depression (QIDS-C16) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Total scores range from 0-27 with higher scores indicating more severe levels of depression. | ClinicalTrials.gov |
| Secondary | Beck Depression Inventory (BDI) | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in self-assessed depression as measured by the Beck Depression Inventory (BDI) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The BDI is a 21-item self-report measure of depression symptoms. Total scores range from 0-63 with higher scores indicating more severe levels of depression. | ClinicalTrials.gov |
| Secondary | Dysfunctional Attitudes Scale Form 18B (DAS-18B) | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in dysfunctional attitudes as measured by change in the Dysfunctional Attitudes Scale Form 18B (DAS-18B) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Each item is endorsed on a 7-point scale (Range: 0-7) such that a total score of 126 is possible with higher scores indicating dysfunctional beliefs which are held more strongly. The total score is comprised of two subscales (perfectionism (Range 0-56); need for social approval (Range 0-21)), which are summed along with 7 other items to calculate the total scale score. | ClinicalTrials.gov |
| Secondary | Metacognitions Questionnaire (MCQ-30) | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in metacognitive beliefs as measured by change in the Metacognitions Questionnaire (MCQ-30) total score and subscale scores from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The 30-item scale has a range of 30-120. The scale is comprised of five subscales (range for each = 6-24): (1) Positive Beliefs (PB) about worry (6 items); (2) Negative Beliefs (NB) about thoughts concerning uncontrollability and danger (6 items), and (3) beliefs about the need to control thoughts (Need for Control \[NFC\],6 items); (4) Cognitive Confidence (6 items) and Cognitive Self-Consciousness (6 items). Higher scores indicate more strongly held metacognitive beliefs. | ClinicalTrials.gov |
| Secondary | Rosenberg Self-Esteem Scale | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in self-esteem as measured by change in the Rosenberg Self-Esteem scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem. | ClinicalTrials.gov |
| Secondary | Ruminative Responses Scale | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in rumination as measured by the Ruminative Responses Scale total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). The scale is comprised of 10 items and scores range from 10-40 with higher scores indicating higher self-esteem. | ClinicalTrials.gov |
| Secondary | World Health Organization Quality of Life-BREF - Item 1 | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in global quality of life as measured by change on item 1 on the World Health Organization Quality of Life-BREF from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Responses on the item range from 1 (very bad quality of life) to 5 (very good quality of life). | ClinicalTrials.gov |
| Secondary | Remission rate | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Remission rate at post-assesment (8 weeks) and follow-up (5 months) as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8) | ClinicalTrials.gov |
| Secondary | EurQoL Group 5Q 5D 5L | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in health status as assessed by change in percentage of participants experiencing health-related difficulties in 5 domains and change in overall health quality as assessed by change on the Visual Analogue rating Scale (VAS; range 0-100; higher scores indicate better quality of life) from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). | ClinicalTrials.gov |
| Secondary | Trail-Making Test, Part B | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in executive functioning as measured by change in the Trail-Making Test, Part B (TMT-B) time to completion from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). A maximum of 300 seconds is allowed and shorter time indicating better performance. | ClinicalTrials.gov |
| Secondary | Trail-Making Test, Part A | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in Information processing speed as measured by change in the the Trail-Making Test A (TMT-A) time to completion from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). A maximum of 300 seconds is allowed and shorter time indicating better performance. | ClinicalTrials.gov |
| Secondary | Rivermead Behavioral Memory Test | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in memory functioning as measured by change in Rivermead Behavioral Memory Test (RBMT) total score from baseline to post-assessment (8 weeks) and baseline to follow-up (5 months). Total scores range from 0-24 with higher scores indicating better memory performance. | ClinicalTrials.gov |
| Secondary | Stroop Color-Word Task | Total Time Frame is 5 months. Outcome is assessed at two points: baseline to post-assessment (8 weeks) and baseline to follow-up (5 months) | Change in executive functions as measured by the Stroop Color-Word test from baseline to post-assessment (8 weeks) and follow-up (5 months). The Stroop Color-Word test is comprised of three trials: Word Reading, Color Naming and Color-Word (CW) Naming. Per the Golden administration guidelines, total score for each subscale is the number of items completed within 45 seconds. For each condition, a raw score of 100 is possible (with a higher score indicating a better performance). For the current study, the Interference score will also be calculated, which is the difference between the expected CW Naming score and the predicted CW Naming score (which is predicted based on age and education; range is -29 to 30 such that larger scores indicate better performance). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 39054326 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)