Cognitive RemediationRestDepNCT04864353
Internet-delivered Intervention Targeting Residual Cognitive Symptoms After Major Depressive Disorder
A study testing RestDep: Internet-delivered intervention targeting residual cognitive symptoms in people with Cognitive Remediation and Cognitive Impairment, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Remediation, Cognitive Impairment, Major Depression in Remission
- What is being tested?
- RestDep: Internet-delivered intervention targeting residual cognitive symptoms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNorway
- Study dates
- 26 Apr 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Self-reported substance abuse
- Neurological conditions or damage (e.g. autism, cerebral haemorrhage, and brain tumour)
- Bipolar disorder
- Psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- RestDep: Internet-delivered intervention targeting residual cognitive symptoms
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestDep: Internet-delivered intervention targeting residual cognitive symptomsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention | Experimental | Participants will after baseline receive a guided intervention with weekly therapist support. Receives: Behavioral: RestDep: Internet-delivered intervention targeting residual cognitive symptoms |
| Control: Waitlist | No intervention | Participants will not receive intervention until 7 weeks after baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2.5 years
Secondary outcomes (8)
Rumination Response Scale
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.
Measured: 2.5 years
Montgomery Aasberg Depression Rating Scale
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.
Measured: 2.5 years
Patient Health Questionaire 9 and 2
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.
Measured: 2.5 years
The Satisfaction With Life Scale
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.
Measured: 2.5 years
The Credibility/Expectancy Questionnaire
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.
Measured: 8 months
Log-ins
Number of sessions were participants have logged into the intervention during the intervention period.
Measured: 8 months
Session length
Average length of each log-in during the intervention period.
Measured: 8 months.
Days in treatment
Number of days in intervention from receiving intervention until completion.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Apr 2021
- Primary completion31 Oct 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive RemediationStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Tine Nordgreen, PhD, Principal investigator, Projectleader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864353
- Sponsor's protocol ID
- 204287
- Acronym
- RestDep
- Status last verified
- Mar 2025
- First submitted
- 21 Apr 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39142571
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04864353
- Acronym / sponsor ID
- RestDep / 204287
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention | Experimental | Behavioral: RestDep: Internet-delivered intervention targeting residual cognitive symptomsParticipants will after baseline receive a guided intervention with weekly therapist support. |
| Control: Waitlist | No intervention | –Participants will not receive intervention until 7 weeks after baseline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Self-reported substance abuse
- Neurological conditions or damage (e.g. autism, cerebral haemorrhage, and brain tumour)
- Bipolar disorder
- Psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RestDep: Internet-delivered intervention targeting residual cognitive symptomsThe 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. | Behavioural | Experimental: Intervention |
Primary outcome
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.
8 secondary outcomes
Rumination Response Scale
Time frame: 2.5 years
Montgomery Aasberg Depression Rating Scale
Time frame: 2.5 years
Patient Health Questionaire 9 and 2
Time frame: 2.5 years
The Satisfaction With Life Scale
Time frame: 2.5 years
The Credibility/Expectancy Questionnaire
Time frame: 8 months
Log-ins
Time frame: 8 months
Session length
Time frame: 8 months.
Days in treatment
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 39142571Myklebost 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine Nordgreen, PhD principal investigator
Projectleader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RestDep: Internet-delivered intervention targeting residual cognitive symptoms in people with Cognitive Remediation and Cognitive Impairment, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviour Rating Inventory Of Executive Function-Adult (time frame: 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.