DepressionNCT01324050
Internet-delivered Psychodynamic Therapy for Depression
A study testing Internet-delivered psychodynamic therapy for depression and Internet-delivered therapist support in people with Depression, run by Linkoeping University at 2 sites in Sweden.
Trial summary
The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Internet-delivered psychodynamic therapy for depression and Internet-delivered therapist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesSweden
- Study dates
- Feb 2011to May 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Major Depressive Disorder
- 15 or more on MADRS-S
Who cannot join
- Severe depression (more than 35 on MADRS-S or based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Suicidal (measured in diagnostic interview)
- Changed medication during the last three months
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Linköping University, Department of Behavioral Sciences and Learning
Linköping
Linköping University
Linköping
About this study
Official title: Internet-delivered Psychodynamic Therapy for Depression: a Randomized Controlled Trial
The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.
- Conditions
- Depression
- Being tested
- Internet-delivered psychodynamic therapy for depression, Internet-delivered therapist support
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered psychodynamic therapy for depressionBehavioural
This intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks.
Internet-delivered therapist supportBehavioural
This intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based Psychodynamic Therapy | Experimental | Not described Receives: Behavioral: Internet-delivered psychodynamic therapy for depression |
| Internet-delivered therapist support | Active comparator | Not described Receives: Behavioral: Internet-delivered therapist support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI)
Measured: Two weeks before the treatment starts
Beck Depression Inventory (BDI)
Measured: At treatment start (0 weeks)
Beck Depression Inventory (BDI)
Measured: At treatment termination (10 weeks)
Secondary outcomes (10)
Beck Anxiety Inventory (BAI)
Measured: Two weeks before the treatment starts
Beck Anxiety Inventory (BAI)
Measured: At treatment termination (10 weeks)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: Two weeks before treatment starts
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: At treatment termination (10 weeks)
Quality of Life Inventory (QOLI)
Measured: Two weeks before treatment starts
Quality of Life Inventory (QOLI)
Measured: At treatment termination (10 weeks)
Patient Health Questionnaire 9 (PHQ-9)
Measured: Two weeks before treatment starts
Patient Health Questionnaire 9 (PHQ-9)
Measured: At treatment termination (10 weeks)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Measured: Two weeks before treatment starts
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Measured: At treatment termination (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Department of Behavioral Sciences and Learning, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324050
- Sponsor's protocol ID
- GA-DEP2011-PDT
- Status last verified
- Jan 2011
- First submitted
- 25 Mar 2011
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansson R, Nyblom A, Carlbring P, Cuijpers P, Andersson G. Choosing between Internet-based psychodynamic versus cognitive behavioral therapy for depression: a pilot preference study. BMC Psychiatry. 2013 Oct 18;13:268. doi: 10.1186/1471-244X-13-268.
PubMed 24139066Johansson R, Ekbladh S, Hebert A, Lindstrom M, Moller S, Petitt E, Poysti S, Larsson MH, Rousseau A, Carlbring P, Cuijpers P, Andersson G. Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PLoS One. 2012;7(5):e38021. doi: 10.1371/journal.pone.0038021. Epub 2012 May 29.
PubMed 22741027
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Psychodynamic Therapy for Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01324050
- Acronym / sponsor ID
- GA-DEP2011-PDT
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Mar 2011 (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 overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based Psychodynamic Therapy | Experimental | Behavioral: Internet-delivered psychodynamic therapy for depression |
| Internet-delivered therapist support | Active comparator | Behavioral: Internet-delivered therapist support |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Major Depressive Disorder
- 15 or more on MADRS-S
Key exclusion criteria (4 listed)
- Severe depression (more than 35 on MADRS-S or based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Suicidal (measured in diagnostic interview)
- Changed medication during the last three months
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 |
|---|---|---|
| Internet-delivered psychodynamic therapy for depressionThis intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks. | Behavioural | Internet-based Psychodynamic Therapy |
| Internet-delivered therapist supportThis intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks. | Behavioural | Internet-delivered therapist support |
Primary outcome
Beck Depression Inventory (BDI)
Time frame: Two weeks before the treatment starts
Beck Depression Inventory (BDI)
Time frame: At treatment start (0 weeks)
Beck Depression Inventory (BDI)
Time frame: At treatment termination (10 weeks)
10 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: Two weeks before the treatment starts
Beck Anxiety Inventory (BAI)
Time frame: At treatment termination (10 weeks)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: Two weeks before treatment starts
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: At treatment termination (10 weeks)
Quality of Life Inventory (QOLI)
Time frame: Two weeks before treatment starts
Quality of Life Inventory (QOLI)
Time frame: At treatment termination (10 weeks)
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Two weeks before treatment starts
Patient Health Questionnaire 9 (PHQ-9)
Time frame: At treatment termination (10 weeks)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time frame: Two weeks before treatment starts
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time frame: At treatment termination (10 weeks)
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 2 Aug 2011.
- Derived from this study: PubMed 24139066Johansson R, Nyblom A, Carlbring P, Cuijpers P, Andersson G. Choosing between Internet-based psychodynamic versus cognitive behavioral therapy for depression: a pilot preference study. BMC Psychiatry. 2013 Oct 18;13:268. doi: 10.1186/1471-244X-13-268.
- Derived from this study: PubMed 22741027Johansson R, Ekbladh S, Hebert A, Lindstrom M, Moller S, Petitt E, Poysti S, Larsson MH, Rousseau A, Carlbring P, Cuijpers P, Andersson G. Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PLoS One. 2012;7(5):e38021. doi: 10.1371/journal.pone.0038021. Epub 2012 May 29.
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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.
Gerhard Andersson, PhD principal investigator
Department of Behavioral Sciences and Learning, Linköping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered psychodynamic therapy for depression and Internet-delivered therapist support in people with Depression, run by Linkoeping University 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 2 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 2 Aug 2011. 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?
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?
Beck Depression Inventory (BDI) (time frame: Two weeks before the treatment starts). The study lists 3 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 NCT01324050, which also lists 2 linked publications.
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 2 Aug 2011.