NCT06101810

Brief Summary

The goal of this study is to examine the effectivity of two self-esteem interventions (COMET (Korrelboom) and CBT (De Neef)) in a general psychiatric population. The main questions it aims to answer are:

  • is there a difference between the two interventions in effectiveness on increasing self-esteem?
  • is there a difference between the two interventions in effect on levels of anxiety, depression and general mental health?
  • are found effects on levels of anxiety, depression and general mental health associated with changes in self-esteem?
  • is the ability to use imagination a moderator for outcomes in both conditions? Participants are randomised over both conditions. At baseline (T0), end of treatment (T1) and follow-up at 6 months (T2) several outcome measures are conducted, such as RSES, DASS and MHC-SF.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress92%
Nov 2023Aug 2026

First Submitted

Initial submission to the registry

August 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

August 14, 2023

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rosenberg self-esteem scale (RSES)

    Rosenberg self-esteem scale assesses global selfesteem on a 10-item questionnaire, items to be answered on a 4-point Likert scale ranging from 0 (strongly agree) to 3 (strongly disagree). Total scores range from 0 up to 30, with higher scores indicating a higher global self-esteem.

    Baseline (T0), end of treatment (T1)(one week after the last intervention session), follow-up (T2 at 6 months)

Secondary Outcomes (3)

  • Depression Anxiety Stress Scale (DASS)

    Baseline (T0), end of treatment (T1)(one week after the last intervention session), follow-up (T2 at 6 months)

  • Mental Health Continuum - Short Form (MHC-SF)

    Baseline (T0), end of treatment (T1)(one week after the last intervention session), follow-up (T2 at 6 months)

  • Plymouth Sensory Imagery Questionnaire (PsiQ-NL-35)

    Baseline (T0)

Other Outcomes (5)

  • Demographics

    Baseline (T0)

  • DSM-5 classifications

    Baseline (T0)

  • Medication (type)

    Measured from start of treatment until end of treatment (T1)(one week after the last intervention session), and from end of treatment (T1)(one week after the last intervention session) until follow-up (T2 at 6 months)

  • +2 more other outcomes

Study Arms (2)

COMET (Korrelboom)

EXPERIMENTAL

Korrelbooms' Competitive Memory Training (2011) (abbreviated COMET) is a cognitive behavioral therapy based on counter-conditioning. It uses positive self-verbalizations, imagination, posture and facial expression and music in a protocolized intervention consisting of 8 weekly group sessions of 90 minutes. For this study the protocol is extended with 1 session, to 9 sessions, in concertation with the author.

Behavioral: COMET

CBT (De Neef)

EXPERIMENTAL

The cognitive behavioural protocol by De Neef (2010; 2018) has not been specifically named but is commonly referred to as 'the whitebook method' or 'cognitive behavioral therapy' (CBT). For convenience, this intervention will be addressed to as CBT in the current study. This intervention relies heavily on positive data logging to specifically focus on evidence that is contradictory to the negative core belief. Patients keep a positive data log (the 'whitebook') to write down positive events and positive qualities of themselves to achieve cognitive bias modification. They also receive psycho-education and practice on alternative behavior such as receiving compliments (which is also regarded as exposure), lowering perfectionist behavior and receiving criticism. In this protocolized intervention patients receive 9 to 11 weekly group sessions of 90 minutes. for this study a version of the protocol with 9 sessions is used.

Behavioral: CBT

Interventions

COMETBEHAVIORAL

information already included in arm/group descriptions.

COMET (Korrelboom)
CBTBEHAVIORAL

information already included in arm/group descriptions.

CBT (De Neef)

Eligibility Criteria

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

You may qualify if:

  • \- A self-perceived low self-esteem established by both patient and caregiver by means of (consent to) referral for self-esteem treatment.

You may not qualify if:

  • severe suicidality for which hospitalization or other forms of crisis care is necessary,
  • acute psychosis,
  • current manic episode,
  • current alcohol or drug abuse,
  • insufficient knowledge of the Dutch language,
  • illiteracy
  • being unable to identify at least one positive aspect of oneself, which does not need to be felt as convincing for the participant. The latter is an excluding criterium formulated by the COMET protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stichting GGZ Noord-Holland-Noord

Heerhugowaard, North Holland, 1703WC, Netherlands

RECRUITING

Study Officials

  • Eva Velthorst, PhD

    GGZ-NHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2023

First Posted

October 26, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations