DepressionELSANCT05109741
Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial
A study testing Internet-based Psychodynamic Therapy and Internet-based Behavioral Activation in people with Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
There are several treatment options for depression, including Internet-delivered psychotherapy. While a majority of this research is based on cognitive behavior therapy (ICBT), there are also several recent studies investigating Internet-delivered psychodynamic therapy (IPDT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Internet-based Psychodynamic Therapy and Internet-based Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2021to 15 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age over 18 years
- A total score ≥10 on the PHQ-9
Who cannot join
- A score of >1 on the PHQ-9 item 9
- A total score >20 on the PHQ-9
- A psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
- Alcohol or substance addiction
Trial locations and contacts
1 site in 1 country.
About this study
There are several treatment options for depression, including Internet-delivered psychotherapy. While a majority of this research is based on cognitive behavior therapy (ICBT), there are also several recent studies investigating Internet-delivered psychodynamic therapy (IPDT). Importantly though, these treatments have never been directly compared in a randomized controlled trial.
In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet.
Read more
Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined.
In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.
Read the detailed description
Depression is a widespread problem in Sweden and the world. The condition causes great suffering for the affected individual and his or her family, and involves major costs for society. There is promising support for psychological treatment of depression in the form of cognitive behavioural therapy and psychodynamic therapy, among others, also as self-help treatment in an internet-based format.
Internet psychodynamic therapy (IPDT) has shown significant effects in the treatment of both depression and anxiety disorders, but also in the treatment of somatic problems. The effects also appear to have improved from end of treatment to follow-up in most studies, with subjects largely completing the full treatment programme. In conclusion, the results for this form of treatment are very promising.
However, internet-based psychodynamic therapy for depression has never been compared with Internet-based CBT (ICBT) in a randomised controlled trial. This is not only an important issue from the perspective of comparing efficacy. Such a comparative study could also provide a basis for gathering information on predictors of treatment response. Based on the psychotherapy literature, there is reason to believe that different patients respond to different treatments. Thus, a comparative study between ICBT and IPDT may also provide a basis for answering the question "Which works for whom?".
In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet.
Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined.
In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.
- Conditions
- Depression
- Being tested
- Internet-based Psychodynamic Therapy, Internet-based Behavioral Activation
- Keywords
- Psychotherapy, Psychodynamic therapy, Behavioral activation, Internet
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Psychodynamic TherapyBehavioural
Internet-based Psychodynamic Therapy based on the SUBGAP model developed by Farrell Silverberg
Internet-based Behavioral ActivationBehavioural
Internet-based Behavioral Activation based on the BATD-R model developed by Carl Lejuez and others.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based Psychodynamic Therapy | Experimental | This is a 10-week treatment based on the psychodynamic SUBGAP model ("Seeing, Understanding, Breaking, and Guarding Against Patterns") by Farrell Silverberg (2005). The treatment has been evaluated in two previous randomized controlled trials.
Silverberg, F. (2005). Make the leap: A practical guide to breaking the patterns that hold you back. Da Capo Press.
Andersson, G., Paxling, B., Roch-Norlund, P., Östman, G., Norgren, A., Almlöv, J., ... \& Silverberg, F. (2012). Internet-based psychodynamic versus cognitive behavioral guided self-help for generalized anxiety disorder: a randomized controlled trial. Psychotherapy and psychosomatics, 81(6), 344-355.
Johansson, R., Ekbladh, S., Hebert, A., Lindström, M., Möller, S., Petitt, E., ... \& Andersson, G. (2012). Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PloS one, 7(5), e38021. Receives: Behavioral: Internet-based Psychodynamic Therapy |
| Internet-based Behavioral Activation | Active comparator | This 10-week treatment is based on the BATD-R ("Behavioral Activation Treatment for Depression - Revised") treatment by Lejuez and others (2011).
Lejuez, C. W., Hopko, D. R., Acierno, R., Daughters, S. B., \& Pagoto, S. L. (2011). Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behavior modification, 35(2), 111-161. Receives: Behavioral: Internet-based Behavioral Activation |
| Waiting-list | No intervention | Participants will be in a 10-week waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of symptoms of depression
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of symptoms of depression
Measured: Post-treatment (10 weeks)
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of symptoms of depression
Measured: 6-month follow-up
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of symptoms of depression
Measured: 12-month follow-up
Secondary outcomes (8)
General Anxiety Questionnaire-7 (GAD-7)
Self-report measure of symptoms of anxiety
Measured: Baseline
General Anxiety Questionnaire-7 (GAD-7)
Self-report measure of symptoms of anxiety
Measured: Post-treatment (10 weeks)
General Anxiety Questionnaire-7 (GAD-7)
Self-report measure of symptoms of anxiety
Measured: 6-month follow-up
General Anxiety Questionnaire-7 (GAD-7)
Self-report measure of symptoms of anxiety
Measured: 12-month follow-up
Brunnsviken Brief Quality of life scale (BBQ)
Self-report measure of quality of life
Measured: Baseline
Brunnsviken Brief Quality of life scale (BBQ)
Self-report measure of quality of life
Measured: Post-treatment (10 weeks)
Brunnsviken Brief Quality of life scale (BBQ)
Self-report measure of quality of life
Measured: 6-month follow-up
Brunnsviken Brief Quality of life scale (BBQ)
Self-report measure of quality of life
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start4 Oct 2021
- Primary completion15 Dec 2021
- Study completion15 May 2023
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 Karolinska InstitutetThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Principal investigator, Robert Johansson, Karolinska Institutet
- Investigators
- Robert Johansson, PhD, Principal investigator, Stockholm University and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109741
- Sponsor's protocol ID
- KIELSA1
- Acronym
- ELSA
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05109741
- Acronym / sponsor ID
- ELSA / KIELSA1
- Conditions
- Depression
- Keywords
- Psychotherapy, Psychodynamic therapy, Behavioral activation, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 5 Nov 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.
There are several treatment options for depression, including Internet-delivered psychotherapy. While a majority of this research is based on cognitive behavior therapy (ICBT), there are also several recent studies investigating Internet-delivered psychodynamic therapy (IPDT). Importantly though, these treatments have never been directly compared in a randomized controlled trial.
In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet.
Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined.
In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.
Detailed description
Depression is a widespread problem in Sweden and the world. The condition causes great suffering for the affected individual and his or her family, and involves major costs for society. There is promising support for psychological treatment of depression in the form of cognitive behavioural therapy and psychodynamic therapy, among others, also as self-help treatment in an internet-based format.
Internet psychodynamic therapy (IPDT) has shown significant effects in the treatment of both depression and anxiety disorders, but also in the treatment of somatic problems. The effects also appear to have improved from end of treatment to follow-up in most studies, with subjects largely completing the full treatment programme. In conclusion, the results for this form of treatment are very promising.
However, internet-based psychodynamic therapy for depression has never been compared with Internet-based CBT (ICBT) in a randomised controlled trial. This is not only an important issue from the perspective of comparing efficacy. Such a comparative study could also provide a basis for gathering information on predictors of treatment response. Based on the psychotherapy literature, there is reason to believe that different patients respond to different treatments. Thus, a comparative study between ICBT and IPDT may also provide a basis for answering the question "Which works for whom?".
In this project, we aim to include 350 patients with depression randomized to ten weeks of IPDT (N=150), ICBT in the form of behavioral activation (N=150) or waiting list (N=50). After the end of the treatment period, patients on the waiting list will also be offered treatment. A secure web platform (KI eHealth Core Facility) will be used to provide treatment via the Internet.
Symptoms of depression will be measured weekly and the effect will be evaluated by comparing the change in the treatment groups with each other and with the change in the waiting list group. Treatment effects and predictors of treatment response will be examined.
In summary, this project is an important step in the continued evaluation of internet-based psychological treatments for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-based Psychodynamic Therapy | Experimental | Behavioral: Internet-based Psychodynamic TherapyThis is a 10-week treatment based on the psychodynamic SUBGAP model ("Seeing, Understanding, Breaking, and Guarding Against Patterns") by Farrell Silverberg (2005). The treatment has been evaluated in two previous randomized controlled trials. Silverberg, F. (2005). Make the leap: A practical guide to breaking the patterns that hold you back. Da Capo Press. Andersson, G., Paxling, B., Roch-Norlund, P., Östman, G., Norgren, A., Almlöv, J., ... \& Silverberg, F. (2012). Internet-based psychodynamic versus cognitive behavioral guided self-help for generalized anxiety disorder: a randomized controlled trial. Psychotherapy and psychosomatics, 81(6), 344-355. Johansson, R., Ekbladh, S., Hebert, A., Lindström, M., Möller, S., Petitt, E., ... \& Andersson, G. (2012). Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PloS one, 7(5), e38021. |
| Internet-based Behavioral Activation | Active comparator | Behavioral: Internet-based Behavioral ActivationThis 10-week treatment is based on the BATD-R ("Behavioral Activation Treatment for Depression - Revised") treatment by Lejuez and others (2011). Lejuez, C. W., Hopko, D. R., Acierno, R., Daughters, S. B., \& Pagoto, S. L. (2011). Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behavior modification, 35(2), 111-161. |
| Waiting-list | No intervention | –Participants will be in a 10-week waiting period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years
- A total score ≥10 on the PHQ-9
Key exclusion criteria (4 listed)
- A score of >1 on the PHQ-9 item 9
- A total score >20 on the PHQ-9
- A psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
- Alcohol or substance addiction
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-based Psychodynamic TherapyInternet-based Psychodynamic Therapy based on the SUBGAP model developed by Farrell Silverberg | Behavioural | Internet-based Psychodynamic Therapy |
| Internet-based Behavioral ActivationInternet-based Behavioral Activation based on the BATD-R model developed by Carl Lejuez and others. | Behavioural | Internet-based Behavioral Activation |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Self-report measure of symptoms of depression
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Post-treatment (10 weeks)
Self-report measure of symptoms of depression
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6-month follow-up
Self-report measure of symptoms of depression
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12-month follow-up
Self-report measure of symptoms of depression
8 secondary outcomes
General Anxiety Questionnaire-7 (GAD-7)
Time frame: Baseline
General Anxiety Questionnaire-7 (GAD-7)
Time frame: Post-treatment (10 weeks)
General Anxiety Questionnaire-7 (GAD-7)
Time frame: 6-month follow-up
General Anxiety Questionnaire-7 (GAD-7)
Time frame: 12-month follow-up
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: Baseline
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: Post-treatment (10 weeks)
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: 6-month follow-up
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: 12-month follow-up
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 3 Oct 2023.
- 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.
Robert Johansson, PhD principal investigator
Stockholm University and Karolinska Institutet
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-based Psychodynamic Therapy and Internet-based Behavioral Activation in people with Depression, run by Karolinska Institutet 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 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 3 Oct 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?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline). 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 3 Oct 2023.