DepressionATLASNCT01532219
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders
A study testing Internet-delivered Psychodynamic Treatment and Internet-delivered structured support in people with Depression and Anxiety, run by Linkoeping University at 1 site in Sweden.
Trial summary
The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with major depression and/or anxiety disorders 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, Anxiety
- What is being tested?
- Internet-delivered Psychodynamic Treatment and Internet-delivered structured support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Dec 2012
- 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, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety disorder, Depressive Disorder NOS or Anxiety Disorder NOS
- 10 or higher on the PHQ-9 or on the GAD-7 at pre-treatment
Who cannot join
- Primary diagnosis of Obsessive Compulsive Disorder or Post-traumatic Stress Disorder
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Alcohol abuse (more than 16 on the AUDIT)
- Suicidal (measured in diagnostic interview)
- Changed medication during the last three months
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Linköping University, Department of Behavioral Sciences and Learning
Linköping, 58183
About this study
Official title: Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders: A Randomized Controlled Trial
The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with major depression and/or anxiety disorders and compare its efficacy to an active control group.
- Conditions
- Depression, Anxiety
- Being tested
- Internet-delivered Psychodynamic Treatment, Internet-delivered structured support
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Psychodynamic TreatmentBehavioural
Ten weeks of guided self-help + therapist contact, via the Internet.
Internet-delivered structured supportBehavioural
Ten weeks of therapist contact, via the Internet.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered Psychodynamic Treatment | Experimental | Participants in the experimental condition will receive 8 text-modules delivered as guided self-help, via the Internet. The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail. The treatment is a short-term psychodynamic treatment psychodynamic treatment. Receives: Behavioral: Internet-delivered Psychodynamic Treatment |
| Internet-delivered structured support | Active comparator | Participants in the active control condition will receive a structured support treatment via the Internet. The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail. Receives: Behavioral: Internet-delivered structured support |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Measured: Two weeks before the treatment starts
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Measured: Two weeks before the treatment starts
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Measured: At treatment start (0 weeks)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Measured: At treatment start (0 weeks)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Measured: At treatment termination (10 weeks)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Measured: At treatment termination (10 weeks)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Measured: At treatment follow-up (7 months)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Measured: At treatment follow-up (7 months)
Secondary outcomes (8)
Emotional Processing Scale (EPS-25)
Measured: Two weeks before the treatment starts
Emotional Processing Scale (EPS-25)
Measured: At treatment start (0 weeks)
Emotional Processing Scale (EPS-25)
Measured: At treatment termination (10 weeks)
Five Facets of Mindfulness Questionnaire (FFMQ)
Measured: Two weeks before the treatment starts
Five Facets of Mindfulness Questionnaire (FFMQ)
Measured: At treatment start (0 weeks)
Five Facets of Mindfulness Questionnaire (FFMQ)
Measured: At treatment termination (10 weeks)
Emotional Processing Scale (EPS-25)
Measured: At treatment follow-up (7 months)
Five Facets of Mindfulness Questionnaire (FFMQ)
Measured: At treatment follow-up (7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by Linkoeping UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532219
- Sponsor's protocol ID
- GA-DEPANX2012-APT
- Acronym
- ATLAS
- Status last verified
- Apr 2013
- First submitted
- 9 Feb 2012
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01532219
- Acronym / sponsor ID
- ATLAS / GA-DEPANX2012-APT
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Feb 2012 (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 major depression and/or anxiety disorders 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-delivered Psychodynamic Treatment | Experimental | Behavioral: Internet-delivered Psychodynamic TreatmentParticipants in the experimental condition will receive 8 text-modules delivered as guided self-help, via the Internet. The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail. The treatment is a short-term psychodynamic treatment psychodynamic treatment. |
| Internet-delivered structured support | Active comparator | Behavioral: Internet-delivered structured supportParticipants in the active control condition will receive a structured support treatment via the Internet. The intervention lasts for 10 weeks and includes weekly contacts with a therapist via a secure online environment similar to e-mail. |
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, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety disorder, Depressive Disorder NOS or Anxiety Disorder NOS
- 10 or higher on the PHQ-9 or on the GAD-7 at pre-treatment
Key exclusion criteria (5 listed)
- Primary diagnosis of Obsessive Compulsive Disorder or Post-traumatic Stress Disorder
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Alcohol abuse (more than 16 on the AUDIT)
- 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 TreatmentTen weeks of guided self-help + therapist contact, via the Internet. | Behavioural | Internet-delivered Psychodynamic Treatment |
| Internet-delivered structured supportTen weeks of therapist contact, via the Internet. | Behavioural | Internet-delivered structured support |
Primary outcome
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: Two weeks before the treatment starts
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Two weeks before the treatment starts
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: At treatment start (0 weeks)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time frame: At treatment start (0 weeks)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: At treatment termination (10 weeks)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time frame: At treatment termination (10 weeks)
9-item Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: At treatment follow-up (7 months)
7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7)
Time frame: At treatment follow-up (7 months)
8 secondary outcomes
Emotional Processing Scale (EPS-25)
Time frame: Two weeks before the treatment starts
Emotional Processing Scale (EPS-25)
Time frame: At treatment start (0 weeks)
Emotional Processing Scale (EPS-25)
Time frame: At treatment termination (10 weeks)
Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: Two weeks before the treatment starts
Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: At treatment start (0 weeks)
Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: At treatment termination (10 weeks)
Emotional Processing Scale (EPS-25)
Time frame: At treatment follow-up (7 months)
Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: At treatment follow-up (7 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 24 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Treatment and Internet-delivered structured support in people with Depression and Anxiety, run by Linkoeping University 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 2 inclusion and 5 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 24 Apr 2013. 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?
9-item Patient Health Questionnaire Depression Scale (PHQ-9) (time frame: Two weeks before the treatment starts). The study lists 8 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 24 Apr 2013.