DepressionISAKNCT01807988
Internetbased Relapse Prevention for Partially Remitted Depression
A study testing iCBT in people with Depression, run by Örebro County Council at 2 sites in Sweden.
Trial summary
The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- iCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2013to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild residual depressive symptoms (7-19 on the MADRS-S).
- A history of at least one episode of Major Depression.
- Currently in (at least) half-time employment, self-employment or education.
- Taking a stable (since one month) and therapeutic dosage of antidepressant medication
- Being able to read and write Swedish
- Having access to the internet
Who cannot join
- Fulfilling the criteria for Major depression
- Psychosis
- Substance abuse
- Suicidality
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Psychiatric Research Centre
Örebro, 70116
Fredrik Holländare, PhD, +46737600700, fredrik.hollandare@orebroll.se
Fredrik Holländare, PhD
- Recruiting
Psychiatric Clinic in Uppsala
Uppsala, 751 85
Lisa Ekselius, PhD, Lisa.Ekselius@neuro.uu.se
About this study
Official title: Regional Study of Internet-based Relapse Prevention as an Adjunct to Partially Successful Antidepressant Medication
The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. We hypothesise that during the two years following the intervention:
- The persons in the group receiving Internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group.
- Fewer persons in the group receiving Internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group.
- The persons in the group receiving Internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group.
- At follow-up, the persons in the group receiving Internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.
- Conditions
- Depression
- Being tested
- iCBT
- Keywords
- Relapse, Recurrence, Depression, Internet, Sick-leave
- Medical subject headings
- Depression, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBTBehavioural
Internetbased cognitive behavior therapy (iCBT) contains interventions that will help the participant to change her behavior to experience more positive reinforcement in daily life and also to challenge her negative patterns of thought. There are also information and exercices to improve sleep, increase physical activity, train mindfulness, handle anxiety and to learn about depression.
| Study group | Role | What they receive |
|---|---|---|
| iCBT | Experimental | Internetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression. Receives: Behavioral: iCBT |
| Control group | No intervention | The control group in the study will fill out questionnaires every month and will be interviewed every month to detect any relapses. They will also receive feedback on there self-reported symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days absent from work due to sick leave
The total number of days that a participant has been absent from work due to sick leave (any cause). Data will be collected from the National Insurance Agency at the end of the study.
Measured: 24 month follow up
Change in self-reported sick leave days
Self-reported number of sick leave days during the study will be collected cumulatively every month during the study time and summarised after 24 months.
Measured: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in diagnostic status
Change in diagnostic status (depressive relapse) will be assessed in a telephone interview every month during the study. The definition of a relapse is to fulfill the diagnostic criteria for major depression according to the DSM-IV at any time after the study start.
Measured: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in depressive symptoms
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. The patient will fill out the questionnaire every month.
Measured: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Secondary outcomes (2)
Change in health related quality of life
Health related quality of life will be measured by an internetbased version of the EQ-5D. The questionnaire will be filled out every month.
Measured: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in costs associated with illness
Change in costs will be measured by an internetbased version of the self-assessment scale Trimbos/iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P).
Measured: Pre- and post treatment, after 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Uppsala University, Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Fredrik Holländare, Örebro County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807988
- Sponsor's protocol ID
- 2012/488
- Acronym
- ISAK
- Status last verified
- Jan 2014
- First submitted
- 6 Mar 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Study of Internet-based Relapse Prevention as an Adjunct to Partially Successful Antidepressant Medication
- ClinicalTrials.gov ID
- NCT01807988
- Acronym / sponsor ID
- ISAK / 2012/488
- Conditions
- Depression
- Keywords
- Relapse, Recurrence, Depression, Internet, Sick-leave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Uppsala University, Uppsala County Council, Sweden
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Mar 2013 (estimated)
- 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.
The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. We hypothesise that during the two years following the intervention:
- The persons in the group receiving Internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group.
- Fewer persons in the group receiving Internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group.
- The persons in the group receiving Internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group.
- At follow-up, the persons in the group receiving Internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT | Experimental | Behavioral: iCBTInternetbased cognitive behavior therapy (iCBT) aimed att preventing relapse into major depression. |
| Control group | No intervention | –The control group in the study will fill out questionnaires every month and will be interviewed every month to detect any relapses. They will also receive feedback on there self-reported symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild residual depressive symptoms (7-19 on the MADRS-S).
- A history of at least one episode of Major Depression.
- Currently in (at least) half-time employment, self-employment or education.
- Taking a stable (since one month) and therapeutic dosage of antidepressant medication
- Being able to read and write Swedish
Key exclusion criteria (4 listed)
- Fulfilling the criteria for Major depression
- Psychosis
- Substance abuse
- Suicidality
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 |
|---|---|---|
| iCBTInternetbased cognitive behavior therapy (iCBT) contains interventions that will help the participant to change her behavior to experience more positive reinforcement in daily life and also to challenge her negative patterns of thought. There are also information and exercices to improve sleep, increase physical activity, train mindfulness, handle anxiety and to learn about depression. | Behavioural | iCBT |
Primary outcome
Days absent from work due to sick leave
Time frame: 24 month follow up
The total number of days that a participant has been absent from work due to sick leave (any cause). Data will be collected from the National Insurance Agency at the end of the study.
Change in self-reported sick leave days
Time frame: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Self-reported number of sick leave days during the study will be collected cumulatively every month during the study time and summarised after 24 months.
Change in diagnostic status
Time frame: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in diagnostic status (depressive relapse) will be assessed in a telephone interview every month during the study. The definition of a relapse is to fulfill the diagnostic criteria for major depression according to the DSM-IV at any time after the study start.
Change in depressive symptoms
Time frame: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in depressive symptoms will be measured by an internetbased version of the Montgomery-Asberg Depression Rating Scale - Self rated. The patient will fill out the questionnaire every month.
2 secondary outcomes
Change in health related quality of life
Time frame: After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 months
Change in costs associated with illness
Time frame: Pre- and post treatment, after 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT in people with Depression, run by Örebro County Council at 2 sites in Sweden.
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 6 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: status not confirmed, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Holländare, PhD (+46737600700, fredrik.hollandare@orebroll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days absent from work due to sick leave (time frame: 24 month follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2014; AzTrials last refreshed its copy on 28 Oct 2026.