Clinical trial NCT05109741: Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial
Official title: Internet-based Psychodynamic Therapy Compared to Behavioral Activation - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Psychotherapy
Psychodynamic therapy
Behavioral activation
Internet
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2021-11-05
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Post-treatment (10 weeks)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6-month follow-up
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12-month follow-up
Secondary outcomes:
measure: General Anxiety Questionnaire-7 (GAD-7)
timeFrame: Baseline
measure: General Anxiety Questionnaire-7 (GAD-7)
timeFrame: Post-treatment (10 weeks)
measure: General Anxiety Questionnaire-7 (GAD-7)
timeFrame: 6-month follow-up
measure: General Anxiety Questionnaire-7 (GAD-7)
timeFrame: 12-month follow-up
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Baseline
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Post-treatment (10 weeks)
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: 6-month follow-up
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Stockholm University and Karolinska Institutet
name: Robert Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References: