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

Haukeland University Hospital

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04864353

204287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Experimental: Intervention

Experimental group

Description:

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

Treatment:

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

Control: Waitlist

No Intervention group

Description:

Participants will not receive intervention until 7 weeks after baseline.