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

Not Applicable

Completed

• Conditions: Cognitive Impairment; Cognitive Remediation; Major Depression in Remission

• Registration Number: NCT04864353
• Lead Sponsor: Haukeland University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study Start: 2021-04-26
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-28
• Primary Completion: 2023-10-31
• Study Completion: 2024-04-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Behaviour Rating Inventory Of Executive Function-Adult	2.5 years	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.
Perceived Deficit Questionnaire 5	2.5 years	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.

Secondary Outcome Measures

Name	Time	Method
The Satisfaction With Life Scale	2.5 years	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.
Log-ins	8 months	Number of sessions were participants have logged into the intervention during the intervention period.
Days in treatment	8 months	Number of days in intervention from receiving intervention until completion.
Rumination Response Scale	2.5 years	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.
Patient Health Questionaire 9 and 2	2.5 years	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.
The Credibility/Expectancy Questionnaire	8 months	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.
Session length	8 months.	Average length of each log-in during the intervention period.
Montgomery Aasberg Depression Rating Scale	2.5 years	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.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway