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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Sequential Assignment|
|Masking Description:||The assessor do not allocate the participant to the intervention or waitlist group.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Log-ins [ Time Frame: 8 months ]Number of sessions were participants have logged into the intervention during the intervention period.
- Session length [ Time Frame: 8 months. ]Average length of each log-in during the intervention period.
- Days in treatment [ Time Frame: 8 months ]Number of days in intervention from receiving intervention until completion.
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
|Contact: Tine Nordgreen, PhD||+47900 94 firstname.lastname@example.org|
|Contact: Sunniva Myklebost, Mscemail@example.com|
|Principal Investigator:||Tine Nordgreen, PhD||Projectleader|