Major DepressionKONRADNCT01788657
iCBT for Depression - Standard Versus Condensed Treatment Material
A study testing Standard internet-based cognitive behavior therapy and Condensed internet-based cognitive behavior therapy in people with Major Depression, run by Örebro County Council at 1 site in Sweden.
Trial summary
Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Standard internet-based cognitive behavior therapy and Condensed internet-based cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteSweden
- Study dates
- 29 Oct 2013to 3 Dec 2017
- 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
- Fullfill criteria for diagnosis of major depression
- Being able to read and write Swedish
- Have access to the internet
- Being a resident in Örebro county
Who cannot join
- Severe depressive symptoms (>34 on the MADRS-S)
- High risk for suicide
- Attending cognitive behavior therapy
- Psychosis
- Bipolar disorder
- Addiction to alcohol or illegal drugs
- A somatic or psychiatric condition that is a contraindication for iCBT or in some way debars iCBT, or have to be treated before depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version
Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. The investigators are not aware of any research that has investigated if slow readers, or persons with difficulty concentrating, can use the standard material or if they would benefit more from using an adapted version.
In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.
Patients will be recruited within Örebro County by referrals and self-referrals. The goal is to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks and all patients will be assessed for depression at an interview with a psychologist. There will also be interviews after treatment and one year after treatment. The most important outcome will be depressive symptoms.
- Conditions
- Major Depression
- Being tested
- Standard internet-based cognitive behavior therapy, Condensed internet-based cognitive behavior therapy
- Keywords
- Depression, Internet, Cognitive Behavior Therapy
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard internet-based cognitive behavior therapyBehavioural
Also called Standard iCBT
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Condensed internet-based cognitive behavior therapyBehavioural
Also called Condensed iCBT
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
| Study group | Role | What they receive |
|---|---|---|
| Standard internet-based cognitive behavior therapy | Experimental | Standard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only). Receives: Behavioral: Standard internet-based cognitive behavior therapy |
| Condensed internet-based cognitive behavior therapy | Experimental | Condensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio). Receives: Behavioral: Condensed internet-based cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms at post-treatment and after 12 months
Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated.
Measured: At baseline, after 12 weeks, after 12 months
Secondary outcomes (7)
Change from baseline in diagnostic status for Major depression
The diagnostic status (depression) will be assessed in a face-to-face interview using the structured material Mini-International Neuropsychiatric Interview (M.I.N.I.).
Measured: Pre-treatment, after 12 weeks and after 1 year
Change from baseline in symptoms of anxiety
Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)
Measured: Pre-treatment, after 12 weeks and after 1 year
Post-treatment treatment satisfaction
Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Measured: After 12 weeks
Therapist time
Therapist time will be measured automatically by the IT-platform and assesses the time spent on each patient by each therapist. A mean time will be calculated to report an estimated time needed to treat one patient with the two interventions.
Measured: Post treatment
Alcohol use
To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.
Measured: Pre treatment
Drug use
To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.
Measured: Pre treatment
Treatment satisfaction at follow up
Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study start29 Oct 2013
- Primary completion3 Dec 2017
- Study completion3 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro County Council
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Fredrik Holländare, Örebro County Council
- Investigators
- Fredrik Holländare, PhD, Principal investigator, Örebro County Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788657
- Sponsor's protocol ID
- Dnr 63:2012
- Acronym
- KONRAD
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2013
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Please contact us with suggestions for collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version
- ClinicalTrials.gov ID
- NCT01788657
- Acronym / sponsor ID
- KONRAD / Dnr 63:2012
- Conditions
- Major Depression
- Keywords
- Depression, Internet, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Örebro County CouncilOther government
- Collaborators
- Karolinska Institutet
- Study start
- 29 Oct 2013 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 3 Dec 2017 (actual)
- First posted
- 11 Feb 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.
Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. The investigators are not aware of any research that has investigated if slow readers, or persons with difficulty concentrating, can use the standard material or if they would benefit more from using an adapted version.
In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.
Patients will be recruited within Örebro County by referrals and self-referrals. The goal is to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks and all patients will be assessed for depression at an interview with a psychologist. There will also be interviews after treatment and one year after treatment. The most important outcome will be depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard internet-based cognitive behavior therapy | Experimental | Behavioral: Standard internet-based cognitive behavior therapyStandard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only). |
| Condensed internet-based cognitive behavior therapy | Experimental | Behavioral: Condensed internet-based cognitive behavior therapyCondensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fullfill criteria for diagnosis of major depression
- Being able to read and write Swedish
- Have access to the internet
- Being a resident in Örebro county
Key exclusion criteria (7 listed)
- Severe depressive symptoms (>34 on the MADRS-S)
- High risk for suicide
- Attending cognitive behavior therapy
- Psychosis
- Bipolar disorder
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 |
|---|---|---|
| Standard internet-based cognitive behavior therapyAlso: Standard iCBTIntroduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention | Behavioural | Standard internet-based cognitive behavior therapy |
| Condensed internet-based cognitive behavior therapyAlso: Condensed iCBTIntroduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention | Behavioural | Condensed internet-based cognitive behavior therapy |
Primary outcome
Change from baseline in depressive symptoms at post-treatment and after 12 months
Time frame: At baseline, after 12 weeks, after 12 months
Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated.
7 secondary outcomes
Change from baseline in diagnostic status for Major depression
Time frame: Pre-treatment, after 12 weeks and after 1 year
Change from baseline in symptoms of anxiety
Time frame: Pre-treatment, after 12 weeks and after 1 year
Post-treatment treatment satisfaction
Time frame: After 12 weeks
Therapist time
Time frame: Post treatment
Alcohol use
Time frame: Pre treatment
Drug use
Time frame: Pre treatment
Treatment satisfaction at follow up
Time frame: After 1 year
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 5 Apr 2023.
- Individual participant dataSharing planned: Yes. Please contact us with suggestions for collaboration.
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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.
Fredrik Holländare, PhD principal investigator
Örebro County Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard internet-based cognitive behavior therapy and Condensed internet-based cognitive behavior therapy in people with Major Depression, run by Örebro County Council at 1 site 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 4 inclusion and 7 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 5 Apr 2023. 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 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?
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?
Change from baseline in depressive symptoms at post-treatment and after 12 months (time frame: At baseline, after 12 weeks, after 12 months). 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 5 Apr 2023.