Internet-delivered Intervention Targeting Residual Cognitive Symptoms After Major Depressive Disorder

Cognitive Impairment Clinical Trial

— RestDep  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864353
• Other study ID #: 204287
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: March 2021
• Source: Haukeland University Hospital
• Contact: Tine Nordgreen, PhD
• Phone: +47900 94 913
• Email: tine.nordgreen[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Objectives: The aim is to assess the clinical effects of an intervention targeting residual cognitive symptoms after major depressive disorder. More specifically, if residual cognitive symptoms would be significantly decreased from pre- to post-treatment and remain stable at the 6-month and 2 year follow-up. Methods: the study is a randomized, waitlist controlled trial including a total of 60 participants (30 in each arm). Primary measures are residual cognitive symptoms measured by the Behavioral Rating Inventory of Executive Functions Adults (BRIEF-A) and Perceived Deficit Questionnaire 5 (PDQ-5). Secondary outcome measures are Depression measured by Montgomery Aasberg Depression Rating Scale and Patient Health Questionnaire 9 and 2 (PHQ-9 and PHQ2), Satisfaction with life measured by Satisfaction with life scale (SWLS), Credibility measured by the Treatment Credibility and Expectation Scale, Rumination measured by the Rumination Response Scale (RRS), Depression screening assessed using the MINI International Psychiatric Interview, Usage data measured by number of log-ins, session length and days in treatment. Quantitative statistical methods will be used to analyze data. Discussion: The results from the study will contribute to field of internet interventions and provide former depressed adults with an easy access intervention in the treatment of residual cognitive symptoms.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cognitive Impairment
• Cognitive Remediation
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression in Remission
• Neurobehavioral Manifestations

Intervention

Behavioral:
• RestDep: Internet-delivered intervention targeting residual cognitive symptoms
The intervention is fully digital with weekly telephone guidance. Key intervention elements are 1) psychoeducation, 2) attention training, 3) strategy training. Cognitive domains as attention, memory and executive functions are covered and rumination.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

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