NCT06866639

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

February 13, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 10, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 13, 2025

Last Update Submit

March 5, 2025

Conditions

Keywords

low self esteemcognitive behavioural therapymetacognitive therapydepressive symptomsanxiety symptoms

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    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 (9)

  • Penn State Worry Questionnaire

    Pre-, post-treatment (8 weeks) and six months follow up

  • Inventory of Interpersonal Problems (IIP-64)

    Pre-, post-treatment (8 weeks) and six months follow up after treatment

  • Ruminative Response Scale

    Pre-, post-treatment (8 weeks) and six months follow up after treatment

  • +6 more other outcomes

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

Cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy

Metacognitive therapy

EXPERIMENTAL

Metacognitive therapy

Behavioral: Metacognitive therapy

Interventions

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.

Cognitive behavioral therapy

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.

Metacognitive therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychosis
  • Bipolar type 1
  • Current suicide intent
  • PTSD
  • Cluster A or cluster B personality disorder
  • Substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Oslo

Oslo, 0373, Norway

Location

MeSH Terms

Conditions

Mental DisordersDepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Roger Hagen, Professor

    University of Oslo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger Hagen, Professor

CONTACT

Leif Edward Ottesen Kennair, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The first group (n=10) will be treated with MCT, whereas the second group (n = 10) will be treated with CBT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2025

First Posted

March 10, 2025

Study Start

March 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

March 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations