Department of Behavioral Sciences and Learning
Linköping, Östergörland, 58183, Sweden
Not Yet Recruiting
NCT Number: NCT06665321
Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Internet-based psychodynamic therapy (IPDT)
BehavioralThe intervention is 9 week long with weekly modules that the participants work with while receiving weekly support from an assigned therapist.
Primary outcomes
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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.
Measure of trait neuroticism. Consists of 24 items. Each item is scored from 0-4 with a total range of 0-96. A higher score reflects a higher level of trait neuroticism.
Secondary outcomes
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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.
12-item measure of trait neuroticism. Each item is score yes or no. Range 0-12 with a higher score indicating higher levels of neuroticism.
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Patient Health Questionnaire-9
Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Measure depressive symptoms. Consist of nine items, scored from 0-3. A higher score indicates more depressive symptoms.
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Generalized Anxiety Disorder-7
Time frame: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptoms.
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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.
Measures quality of life. 12 items scored from 0-4. A higher score indicates higher quality of life.
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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.
Measure of emotion regulation. Consists of 16 items scored from 1-5. A higher score indicates less adaptive emotion regulation.
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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.
Measures adaptiveness of defense mechanisms. Consists of 30 items scored from 0-4. A higher overall defense score (ODF) indicates more more adaptive defense mechanisms.
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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.
Brief measurer of depressive and anxiety symptoms. Consists of 4 items, scored from 0-3. A higher score indicates more symptoms.
Study contacts
Contact information is provided by the study sponsor or research team.
Gerhard Andersson, PhD
CONTACT
Tomas Lindegaard, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Linkoeping University
Other Gov
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Oct 30, 2024
- Registry last updated
- Nov 12, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.