Trait NeuroticismNCT06665321
Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial
A study testing Internet-based psychodynamic therapy (IPDT) in people with Trait Neuroticism, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trait Neuroticism
- What is being tested?
- Internet-based psychodynamic therapy (IPDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tomas Lindegaard, PhD contact
Sweden1 site
Department of Behavioral Sciences and Learning
Linköping, Östergörland, 58183
Gerhard Andersson, PhD, +46-13285840, gerhard.andersson@liu.se
About this study
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.
Read the 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.
- Conditions
- Trait Neuroticism
- Being tested
- Internet-based psychodynamic therapy (IPDT)
- Keywords
- Trait neuroticism, Internet-delivered psychodynamic therapy, Internet Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based psychodynamic therapy (IPDT)Behavioural
The intervention is 9 week long with weekly modules that the participants work with while receiving weekly support from an assigned therapist.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based psychodynamic therapy | Experimental | The treatment consist of a 9 week long IPDT intervention based on Affect Phobia Therapy with weekly therapist support. Receives: Behavioral: Internet-based psychodynamic therapy (IPDT) |
| Wait-list control condition | No intervention | Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation
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.
Measured: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Secondary outcomes (7)
Eysenck Personality Questionnaire Revised - Shortform (EPQR-S)
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.
Measured: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Patient Health Questionnaire-9
Measure depressive symptoms. Consist of nine items, scored from 0-3. A higher score indicates more depressive symptoms.
Measured: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Generalized Anxiety Disorder-7
Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptoms.
Measured: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Brunnsviken Brief Quality of life scale
Measures quality of life. 12 items scored from 0-4. A higher score indicates higher quality of life.
Measured: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Difficulties in Emotion Regulation Scale-16
Measure of emotion regulation. Consists of 16 items scored from 1-5. A higher score indicates less adaptive emotion regulation.
Measured: 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
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.
Measured: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Patient Health Questionnaire - 4
Brief measurer of depressive and anxiety symptoms. Consists of 4 items, scored from 0-3. A higher score indicates more symptoms.
Measured: Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trait NeuroticismStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After recruitment finished, participants will be randomized to either IPDT treatment or wait-list control condition.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665321
- Sponsor's protocol ID
- LINNEA
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06665321
- Acronym / sponsor ID
- LINNEA
- Conditions
- Trait Neuroticism
- Keywords
- Trait neuroticism, Internet-delivered psychodynamic therapy, Internet Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Jan 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After recruitment finished, participants will be randomized to either IPDT treatment or wait-list control condition.
| Arm | Type | Receives |
|---|---|---|
| Internet-based psychodynamic therapy | Experimental | Behavioral: Internet-based psychodynamic therapy (IPDT)The treatment consist of a 9 week long IPDT intervention based on Affect Phobia Therapy with weekly therapist support. |
| Wait-list control condition | No intervention | –Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Internet-based psychodynamic therapy |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Lindegaard, PhD contact
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based psychodynamic therapy (IPDT) in people with Trait Neuroticism, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Andersson, PhD (+46-13285840, gerhard.andersson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.