Clinical trial NCT06866639: Cognitive Behavioural Therapy/Metacognitive Therapy for Low Self Esteem
Official title: Cognitive Behavioural Therapy/Metacognitive Therapy for Low Self Esteem
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Disorders
Keywords: low self esteem
cognitive behavioural therapy
metacognitive therapy
depressive symptoms
anxiety symptoms
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2025-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT
Primary purpose: TREATMENT

Brief 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, (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.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent obtained prior to entry in the study.
2. Scores below 15 on the Rosenberg Self-esteem Scale (RSE)
3. 18 years or older.

Exclusion Criteria:

1. Psychosis
2. Bipolar type 1
3. Current suicide intent
4. PTSD
5. Cluster A or cluster B personality disorder
6. Substance dependence

Primary outcomes:
measure: Rosenberg Self Esteem Scale
timeFrame: 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:
measure: GAD-7
timeFrame: 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
measure: PHQ-9
timeFrame: 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
Other outcomes:
measure: Penn State Worry Questionnaire
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up
measure: Inventory of Interpersonal Problems (IIP-64)
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: Ruminative Response Scale
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: Robson Self Concept Questionnaire
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: Metacognitive Questionnaire-30
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: BRIEF-A
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: CANTAB Intra-Extra Dimensional Set Shift
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: CANTAB Spatial Working Memory
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
measure: CANTAB Stop Signal Task
timeFrame: Pre-, post-treatment (8 weeks) and six months follow up after treatment
Locations:
city: Oslo
country: Norway
facility: Department of Psychology, University of Oslo
Study officials:
affiliation: University of Oslo
name: Roger Hagen, Professor
role: PRINCIPAL_INVESTIGATOR
References: