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Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial

Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05109741
Acronym
ELSA
Enrollment
189
Registered
2021-11-05
Start date
2021-10-04
Completion date
2023-05-15
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Psychotherapy, Psychodynamic therapy, Behavioral activation, Internet

Brief 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). 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.

Interventions

BEHAVIORALInternet-based Psychodynamic Therapy

Internet-based Psychodynamic Therapy based on the SUBGAP model developed by Farrell Silverberg

BEHAVIORALInternet-based Behavioral Activation

Internet-based Behavioral Activation based on the BATD-R model developed by Carl Lejuez and others.

Sponsors

Stockholm University
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age over 18 years * A total score ≥10 on the PHQ-9

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)BaselineSelf-report measure of symptoms of depression

Secondary

MeasureTime frameDescription
General Anxiety Questionnaire-7 (GAD-7)BaselineSelf-report measure of symptoms of anxiety
Brunnsviken Brief Quality of life scale (BBQ)BaselineSelf-report measure of quality of life

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026