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

NCT04864353 | Completed

• 1 other identifier: 204287
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Remediation; Cognitive Impairment; Major Depression in Remission

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Rumination Response Scale

  2.5 years

• Montgomery Aasberg Depression Rating Scale

  2.5 years

• Patient Health Questionaire 9 and 2

  2.5 years

• The Satisfaction With Life Scale

  2.5 years

• The Credibility/Expectancy Questionnaire

  8 months

Study Arms (2)

Experimental: Intervention

EXPERIMENTAL

Participants will after baseline receive a guided intervention with weekly therapist support.

Behavioral: RestDep: Internet-delivered intervention targeting residual cognitive symptoms

Control: Waitlist

NO INTERVENTION

Participants will not receive intervention until 7 weeks after baseline.

Interventions

RestDep: Internet-delivered intervention targeting residual cognitive symptoms BEHAVIORAL

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.

Experimental: Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Self-reported substance abuse
• Neurological conditions or damage (e.g. autism, cerebral haemorrhage, and brain tumour)
• Bipolar disorder
• Psychosis.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (1)

• 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.

  PMID: 39142571 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tine Nordgreen, PhD

  Projectleader

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The assessor do not allocate the participant to the intervention or waitlist group.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 28, 2021
• Study Start: April 26, 2021
• Primary Completion: October 31, 2023
• Study Completion: April 30, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)