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

NCT ID: NCT04864353

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2024-04-30

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.

Conditions

Cognitive Remediation; Cognitive Impairment; Major Depression in Remission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Intervention

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

Group Type: EXPERIMENTAL

RestDep: Internet-delivered intervention targeting residual cognitive symptoms

Intervention Type: 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.

Control: Waitlist

Participants will not receive intervention until 7 weeks after baseline.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tine Nordgreen, PhD

Role: PRINCIPAL_INVESTIGATOR

Projectleader

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 39142571 (View on PubMed)

Other Identifiers

204287

Identifier Type: -

Identifier Source: org_study_id