Psychological DisordersNCT06866639
Cognitive Behavioural Therapy/Metacognitive Therapy for Low Self Esteem
A study testing Cognitive behavioral therapy and Metacognitive therapy in people with Psychological Disorders, run by University of Oslo at 1 site in Norway.
Trial summary
The goal for this clinical trial is to explore the effect of CBT/MCT on the treatment of low self esteem. 20 patients with low self-esteem will be selected and distributed into two either MCT or a CBT We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Disorders
- What is being tested?
- Cognitive behavioral therapy and Metacognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed written informed consent obtained prior to entry in the study.
- Scores below 15 on the Rosenberg Self-esteem Scale (RSE)
- 18 years or older.
Who cannot join
- Psychosis
- Bipolar type 1
- Current suicide intent
- PTSD
- Cluster A or cluster B personality disorder
- Substance dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Department of Psychology, University of Oslo
Oslo, 0373
Roger Hagen, 48109789, roger.hagen@ntnu.no
Roger Hagen, Professor
About this study
The goal for this clinical trial is to explore the effect of CBT/MCT on the treatment of low self esteem. 20 patients with low self-esteem will be selected and distributed into two either MCT or a CBT
We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.
Read the detailed description
The association between low self-esteem and psychiatric disorders indicates that low self-esteem is an important transdiagnostic construct. People who report having a low self-esteem seem to experience more mental health problems and a reduction in quality of life.
There have been a few trials considering the effect of Cognitive Behavioural Therapy (CBT) for low self-esteem, however, there are few randomized controlled studies. Recently, Meta Cognitive Therapy (MCT) has been introduced as a new, specific treatment for MDD, showing promising and lasting results. This treatment approach also has proven more effective than CBT for GAD or worry disorder. So far, no study has examined MCT for low self-esteem in a randomized controlled trial.
For the present clinical trial, 20 patients with low self-esteem will be selected and distributed into two treatment conditions. The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT. The patients will be assessed with different outcome measures at pre-treatment, at the end of treatment, and at six months follow up. In addition, they will also be assessed weekly using various measures.
We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.
- Conditions
- Psychological Disorders
- Being tested
- Cognitive behavioral therapy, Metacognitive therapy
- Keywords
- low self esteem, cognitive behavioural therapy, metacognitive therapy, depressive symptoms, anxiety symptoms
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
The CBT is based on the treatment manual written by Fennell (1997). The patients receiving CBT will be treated for 8 sessions, with weekly session of 45-60 minutes duration.
Metacognitive therapyBehavioural
The meta-cognitive treatment program is based on Wells's metacognitive therapy (Wells, 2013). The patients receiving meta-cognitive therapy will be treated for 8 sessions, with weekly session of 45-60 minutes duration.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy Receives: Behavioral: Cognitive behavioral therapy |
| Metacognitive therapy | Experimental | Metacognitive therapy Receives: Behavioral: Metacognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosenberg Self Esteem Scale
The purpose of the 10 item RSE scale is to measure self-esteem.The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem
Measured: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks), and six months follow up
Secondary outcomes (2)
GAD-7
The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day". Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks, post-treatment (8 weeks) and six months follow up
PHQ-9
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively
Measured: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks) and six months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DisordersStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Roger Hagen, University of Oslo
- Investigators
- Roger Hagen, Professor, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866639
- Sponsor's protocol ID
- LSE06064685
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy/Metacognitive Therapy for Low Self Esteem
- ClinicalTrials.gov ID
- NCT06866639
- Acronym / sponsor ID
- LSE06064685
- Conditions
- Psychological Disorders
- Keywords
- low self esteem, cognitive behavioural therapy, metacognitive therapy, depressive symptoms, anxiety symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 10 Mar 2025 (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 goal for this clinical trial is to explore the effect of CBT/MCT on the treatment of low self esteem. 20 patients with low self-esteem will be selected and distributed into two either MCT or a CBT
We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.
Detailed description
The association between low self-esteem and psychiatric disorders indicates that low self-esteem is an important transdiagnostic construct. People who report having a low self-esteem seem to experience more mental health problems and a reduction in quality of life.
There have been a few trials considering the effect of Cognitive Behavioural Therapy (CBT) for low self-esteem, however, there are few randomized controlled studies. Recently, Meta Cognitive Therapy (MCT) has been introduced as a new, specific treatment for MDD, showing promising and lasting results. This treatment approach also has proven more effective than CBT for GAD or worry disorder. So far, no study has examined MCT for low self-esteem in a randomized controlled trial.
For the present clinical trial, 20 patients with low self-esteem will be selected and distributed into two treatment conditions. The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT. The patients will be assessed with different outcome measures at pre-treatment, at the end of treatment, and at six months follow up. In addition, they will also be assessed weekly using various measures.
We aim in this study to (1) evaluate the accessibility and effectiveness of MCT and CBT in treating low self-esteem, (2) investigate the patterns of change and the mechanisms of action involved during treatment, and (3) examine the impact of meta-cognitions and neuropsychologial processes in the treatment response and any relapse prevention of low self-esteem.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapyCognitive behavioral therapy |
| Metacognitive therapy | Experimental | Behavioral: Metacognitive therapyMetacognitive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed written informed consent obtained prior to entry in the study.
- Scores below 15 on the Rosenberg Self-esteem Scale (RSE)
- 18 years or older.
Key exclusion criteria (6 listed)
- Psychosis
- Bipolar type 1
- Current suicide intent
- PTSD
- Cluster A or cluster B personality disorder
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 |
|---|---|---|
| Cognitive behavioral therapyThe CBT is based on the treatment manual written by Fennell (1997). The patients receiving CBT will be treated for 8 sessions, with weekly session of 45-60 minutes duration. | Behavioural | Cognitive behavioral therapy |
| Metacognitive therapyThe meta-cognitive treatment program is based on Wells's metacognitive therapy (Wells, 2013). The patients receiving meta-cognitive therapy will be treated for 8 sessions, with weekly session of 45-60 minutes duration. | Behavioural | Metacognitive therapy |
Primary outcome
Rosenberg Self Esteem Scale
Time frame: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks), and six months follow up
The purpose of the 10 item RSE scale is to measure self-esteem.The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem
2 secondary outcomes
GAD-7
Time frame: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks, post-treatment (8 weeks) and six months follow up
PHQ-9
Time frame: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks) and six months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Roger Hagen, Professor principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy and Metacognitive therapy in people with Psychological Disorders, run by University of Oslo at 1 site in Norway.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Mar 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roger Hagen, Professor (+4748109789, roger.hagen@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rosenberg Self Esteem Scale (time frame: Baseline scores each week over two weeks before pre-treatment, pre-treatment, each session each week over 8 weeks , post-treatment (8 weeks), and six months follow up). 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 10 Mar 2025.