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NCT Number: NCT06101810

The Efficacy of Treatments to Improve Self-esteem

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.

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Key information

Conditions

Self Esteem

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting GGZ Noord-Holland-Noord

Heerhugowaard, North Holland, 1703WC, Netherlands

Location status: Recruiting

Location contact

Ellen de Jonge

CONTACT

[email protected]

About this study

In this study, the investigators will examine the effectivity of self-esteem interventions.

To achieve this goal, the primary aim of this study is to examine if there is a difference in effectiveness between two interventions that have shown to be effective in ameliorating levels of low self-esteem in previous studies (ie. COMET (Korrelboom) and CBT (De Neef)).

Secondly, the investigators would like to find out if self-esteem interventions have an effect on levels of depression, anxiety and general mental health. This would give us a better understanding of the role of self-esteem as a trans-diagnostic factor.

The final aim of this study is to find out if some patients might profit more from one intervention over the other. One of the main differences between both interventions is that COMET heavily relies on imagination techniques and CBT does not. It could be possible that the extend to which patients are able to profit from an intervention which relies on imagination, depends on the ability or vividness in which they are able to use imagery. In this study the investigators will investigate if the ability to use mental imagery has an effect on treatment effects.

Design - In this study, research questions will be answered using a randomized clinical trial. After inclusion, patients are randomly assigned to one of the two conditions: 9 weeks of COMET + (ongoing) TAU versus 9 weeks of CBT + (ongoing) TAU. After baseline assessment participants will be randomized.

Population - All participants are adult (aged 18-65) outpatients of the regional community mental health teams of GGZ Noord-Holland Noord, a large secondary mental health care centre in the Netherlands with several locations. These teams treat patients with serious and complex psychiatric problems with any DSM-5 diagnosis (except those with a primary diagnosis of drug or alcohol related disorders and those with severe learning disabilities).

Including criterium is a self-perceived low self-esteem established by both patient and caregiver by means of (consent to) referral for self-esteem treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Comet

Behavioral

information already included in arm/group descriptions.

CBT

Behavioral

information already included in arm/group descriptions.

Primary outcomes

  1. Rosenberg self-esteem scale (RSES)

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

    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.

Secondary outcomes

  1. Depression Anxiety Stress Scale (DASS)

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

    Depression Anxiety Stress Scale is a 42-item questionnaire with items rated on a 4-point Likert scale, ranging from 0 (never) to 3 (definitely or most of the time). The DASS consists of three subscales of 14 items: Depression, Anxiety and Stress. Total scores on the subscales range from 0 up to 42, with higher scores indicating a higher levels of distress.

  2. Mental Health Continuum - Short Form (MHC-SF)

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

    Mental Health Continuum - Short Form is a 14 item questionnaire with items to be rated on a 6-point Likert scale, ranging from 0 (never) to 5 (every day). Higher scores mean a better outcome. Total score intends to measure positive mental health as a distinct indicator of mental well-being. Three subscales are Emotional well-being (presence of positive feelings), Psychological well-being (positive functioning in individual life) and Social well-being (positive functioning in community life).

    Higher scores indicate more well-being.

  3. Plymouth Sensory Imagery Questionnaire (PsiQ-NL-35)

    Time frame: Baseline (T0)

    Plymouth Sensory Imagery Questionnaire is a 35 item questionnaire. It assesses mental imagery vividness on 5 items for 7 modalities (i.e., vision, sound, smell, taste, touch, bodily sensation and emotion). Each of the 7 modalities have a heading such as 'imagine the smell of…', followed by 5 items such as 'a rose' or 'burning wood'. Items are to be rated on a 11-point scale (0-10), ranging from 0 (no image at all) to 10 (as vivid as real life).

Other outcomes

  1. Demographics

    Time frame: Baseline (T0)

    Demographics

  2. DSM-5 classifications

    Time frame: Baseline (T0)

    Classifications according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)

  3. Medication (type)

    Time frame: 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)

    Type of medication

  4. Medication (dose)

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

    Dose of medication per type of medication

  5. Other forms of treatment

    Time frame: 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)

    Number of hours of other forms of treatment (Treatment As Usual/TAU) over the previous period.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen de Jonge, MSc

CONTACT

[email protected]

(0031) 06 12526264

Eva Velthorst, PhD

CONTACT

[email protected]

(0031) 06 18644345

Sponsors and collaborators

Lead sponsor

GGZ Noord-Holland-Noord

Other

Registry information

Official study title

Self-esteem in a General Psychiatric Population: Comparing Competitive Memory Training (COMET) and Cognitive Behavioral Therapy (CBT)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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