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

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ClinicalTrials.gov Identifier: NCT04864353
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cognitive Remediation Cognitive Impairment Major Depression in Remission Behavioral: RestDep: Internet-delivered intervention targeting residual cognitive symptoms Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Masking Description: The assessor do not allocate the participant to the intervention or waitlist group.
Primary Purpose: Treatment
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
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : December 22, 2023
Estimated Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: Intervention
Participants will after baseline receive a guided intervention with weekly therapist support.
Behavioral: 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.

No Intervention: Control: Waitlist
Participants will not receive intervention until 7 weeks after baseline.



Primary Outcome Measures :
  1. Behaviour Rating Inventory Of Executive Function-Adult [ Time Frame: 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.

  2. Perceived Deficit Questionnaire 5 [ Time Frame: 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 :
  1. Rumination Response Scale [ Time Frame: 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.

  2. Montgomery Aasberg Depression Rating Scale [ Time Frame: 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.

  3. Patient Health Questionaire 9 and 2 [ Time Frame: 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.

  4. The Satisfaction With Life Scale [ Time Frame: 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.

  5. The Credibility/Expectancy Questionnaire [ Time Frame: 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.

  6. Log-ins [ Time Frame: 8 months ]
    Number of sessions were participants have logged into the intervention during the intervention period.

  7. Session length [ Time Frame: 8 months. ]
    Average length of each log-in during the intervention period.

  8. Days in treatment [ Time Frame: 8 months ]
    Number of days in intervention from receiving intervention until completion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864353


Contacts
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Contact: Tine Nordgreen, PhD +47900 94 913 tine.nordgreen@helse-bergen.no
Contact: Sunniva Myklebost, Msc +4798437717 sunniva.myklebost@uib.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Tine Nordgreen, PhD       tine.nordgreen@helse-bergen.no   
Contact: Sunniva Myklebost, Msc       sunniva.myklebost@uib.no   
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
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Principal Investigator: Tine Nordgreen, PhD Projectleader
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04864353    
Other Study ID Numbers: 204287
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases