Clinical trial NCT04864353: Internet-delivered Intervention Targeting Residual Cognitive Symptoms After Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Remediation
Cognitive Impairment
Major Depression in Remission
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2021-04-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Behaviour Rating Inventory Of Executive Function-Adult
timeFrame: 2.5 years
measure: Perceived Deficit Questionnaire 5
timeFrame: 2.5 years
Secondary outcomes:
measure: Rumination Response Scale
timeFrame: 2.5 years
measure: Montgomery Aasberg Depression Rating Scale
timeFrame: 2.5 years
measure: Patient Health Questionaire 9 and 2
timeFrame: 2.5 years
measure: The Satisfaction With Life Scale
timeFrame: 2.5 years
measure: The Credibility/Expectancy Questionnaire
timeFrame: 8 months
measure: Log-ins
timeFrame: 8 months
measure: Session length
timeFrame: 8 months.
measure: Days in treatment
timeFrame: 8 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Projectleader
name: Tine Nordgreen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myklebost SB, Heltne A, Hammar A, Nordgreen T. Efficacy of an internet-delivered cognitive enhancement intervention for subjective residual cognitive deficits in remitted major depressive disorder: A randomized crossover trial. J Affect Disord. 2024 Nov 1;364:87-95. doi: 10.1016/j.jad.2024.08.035. Epub 2024 Aug 12.