Cognitive Impairment Clinical Trial
— RestDepOfficial title:
A Guided Internet-delivered Intervention for Adults With Residual Cognitive Symptoms After Major Depressive Disorder: Study Protocol for a Randomized Controlled Trial Investigating Clinical Effects
NCT number | NCT04864353 |
Other study ID # | 204287 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 26, 2021 |
Est. completion date | January 15, 2024 |
Background: Cognitive impairment and difficulties are frequently observed in individuals suffering from major depressive disorder. These impairments and difficulties can persist into remission as residual cognitive symptoms. Consequently affecting daily life functioning and quality of life for those affected. Few scalable interventions have targeted these symptoms and measured long-term clinical effects such as depression relapse.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 15, 2024 |
Est. primary completion date | December 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Previously received treatment for major depressive disorder in primary or secondary healthcare services - Reporting a history of major depressive disorder symptoms assess using the MINI. few or minor depression symptomss (< 12 MADRS) - Not meeting criteria for major depressive disorder measured by the MINI) - Self-reporting residual cognitive symptoms that affects daily functioning (assessed by clinical psychologist) - No changes in anti-depressant medication under the study period - Age between 18 and 65 years - Read and write Norwegian - Internet and telephone access. Exclusion Criteria: - Self-reported substance abuse - Neurological conditions or damage (e.g. autism, cerebral haemorrhage, and brain tumour) - Bipolar disorder - Psychosis. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | University of Bergen |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behaviour Rating Inventory Of Executive Function-Adult | The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A; Roth, Isquith, & Gioia, 2005) is a 75-item self-report questionnaire designed to measure adults' behaviors associated with executive problems. | 2.5 years | |
Primary | Perceived Deficit Questionnaire 5 | Brief assessment of subjective cognitive difficulties and covers problems with concentration (e.g. "trouble concentrating on things like watching a television program or reading a book?"), memory (e.g. "forget what you talked about after a telephone conversation?"), and executive functioning (e.g. "have trouble getting things organized?"). Every item is rated on a scale of 0 (Never) to 4 (Almost always) to yield a sum score of 0 to 20, with higher scores indicating greater severity of cognitive symptoms. | 2.5 years | |
Secondary | Rumination Response Scale | The Rumination Response Scale (RRS; Treynor, Gonzalez, & Nolen-Hoeksema, 2003) is a questionnaire frequently used to assess rumination in depression. The 22-item RRS measures the current degree of ruminative responses to depressed mood. | 2.5 years | |
Secondary | Montgomery Aasberg Depression Rating Scale | The Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S; Svanborg & Åsberg, 2001) is a self-report questionnaire measuring depressive symptoms during the past three days. The MADRS-S consists of 9 items where the following symptoms are rated on a seven-point scale ranging from 0 to 6. | 2.5 years | |
Secondary | Patient Health Questionaire 9 and 2 | The Patient Health Questionnaire-9 (PHQ-9: Kroenke et al., 2001) is a self-report tool used to assess the presence and severity of depressive symptoms. Reliability and validity of the tool have indicated it has sound psychometric properties. Internal consistency of the PHQ-9 has been shown to be high. | 2.5 years | |
Secondary | The Satisfaction With Life Scale | The SWLS (Kobau et al., 2010) is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life. The scale usually requires only about one minute of a respondent's time. | 2.5 years | |
Secondary | The Credibility/Expectancy Questionnaire | The Credibility/Expectancy Questionnaire (Borkovec & Nau, 1972) measures treatment credibility and expectancy. Participants rated perceived treatment credibility and expectancy on a scale from 0 to 10 were higher scores indicated better treatment credibility or expectancy. | 8 months | |
Secondary | Log-ins | Number of sessions were participants have logged into the intervention during the intervention period. | 8 months | |
Secondary | Session length | Average length of each log-in during the intervention period. | 8 months. | |
Secondary | Days in treatment | Number of days in intervention from receiving intervention until completion. | 8 months |
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