Clinical trial NCT06665321: Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial
Official title: Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trait Neuroticism
Keywords: Trait neuroticism
Internet-delivered psychodynamic therapy
Internet Intervention
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2024-10-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After recruitment finished, participants will be randomized to either IPDT treatment or wait-list control condition.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation
timeFrame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Secondary outcomes:
measure: Eysenck Personality Questionnaire Revised - Shortform (EPQR-S)
timeFrame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
measure: Patient Health Questionnaire-9
timeFrame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
measure: Generalized Anxiety Disorder-7
timeFrame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
measure: Brunnsviken Brief Quality of life scale
timeFrame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
measure: Difficulties in Emotion Regulation Scale-16
timeFrame: 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.
measure: Defense Mechanism Rating Scale - Self Report 30
timeFrame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
measure: Patient Health Questionnaire - 4
timeFrame: Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning
state: Östergörland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: