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Not yet recruiting NCT06665321

Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial

No phase Interventional Trait Neuroticism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internet-based psychodynamic therapy (IPDT).
Who it may be relevant to
Registry conditions: Trait Neuroticism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of the study is to investigate if internet delivered affect-focused psychodynamic therapy (IPDT) leads to lowered levels of trait neuroticism compared to a wait-list control condition. The target group is adults (18+) who experience mild to moderate symptoms of anxiety and/or depression. The IPDT treatment consists of 8 modules that the participants will work with for 9 weeks, with therapist support. Participants will be recruited in Sweden with nationwide recruitment.

Detailed description

This study is a randomized controlled trial with the aim to investigate if IPDT leads to lowered levels of trait neuroticism. Participants will either be randomized to the treatment which is based on Affect Phobia Therapy or to a wait-list control. Participants will have weekly contact with a therapist who will provide feedback and support.

Primary outcome measure is trait neuroticism (measured on the 24-Item Neuroticism scale of the IPIP-NEO-120). Secondary outcome measures will include measures of anxiety, depression, quality of life, emotion regulation, and defense mechanism adaptiveness. Emotion regulation and short measure of anxiety and depressive symptoms will be collected weekly throughout the treatment period. Pre-treatment measurement, post-treatment measurement, weekly measure, and one-year follow up is planned to be collected through an online survey.

Interventions

  • Behavioral Internet-based psychodynamic therapy (IPDT)
    The intervention is 9 week long with weekly modules that the participants work with while receiving weekly support from an assigned therapist.

Primary outcome measures

  • Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
Secondary outcome measures (7)
  • Eysenck Personality Questionnaire Revised - Shortform (EPQR-S) [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Patient Health Questionnaire-9 [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Generalized Anxiety Disorder-7 [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Brunnsviken Brief Quality of life scale [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Difficulties in Emotion Regulation Scale-16 [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination. Will be measured on a weekly basis during the 9 weeks of the intervention period.]
  • Defense Mechanism Rating Scale - Self Report 30 [Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.]
  • Patient Health Questionnaire - 4 [Time frame: Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.]

Eligibility criteria

Inclusion criteria

  • Score 5 points or more on either the PHQ-9 or GAD-7
  • 18 years or older
  • Ability to speak, read and write in Swedish
  • Have access to the internet and a smartphone, computer or other device

Exclusion criteria

  • Severe psychiatric or somatic illness that makes participation difficult or impossible
  • Ongoing addiction
  • Acute suicidality
  • Other ongoing psychological treatment
  • Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Department of Behavioral Sciences and Learning — Linköping

Identifiers

NCT: NCT06665321 · LINNEA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗