The Efficacy of Treatments to Improve Self-esteem

Self Esteem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101810
• Other study ID #: GGZNHN23EJ
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: GGZ Noord-Holland-Noord
• Contact: Ellen de Jonge, MSc
• Phone: (0031) 06 12526264
• Email: e.dejonge[@]ggz-nhn.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Self Esteem

Intervention

Behavioral:
• COMET
information already included in arm/group descriptions.
• CBT
information already included in arm/group descriptions.

Locations

Country	Name	City	State
Netherlands	Stichting GGZ Noord-Holland-Noord	Heerhugowaard	North Holland

Sponsors (1)

Lead Sponsor	Collaborator
GGZ Noord-Holland-Noord

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Demographics	Baseline (T0)
Other	DSM-5 classifications	Classifications according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)	Baseline (T0)
Other	Medication (type)	Type of medication	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)
Other	Medication (dose)	Dose of medication per type of medication	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)
Other	Other forms of treatment	Number of hours of other forms of treatment (Treatment As Usual/TAU) over the previous period.	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)
Primary	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	Depression Anxiety Stress Scale (DASS)	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.	Baseline (T0), end of treatment (T1)(one week after the last intervention session), follow-up (T2 at 6 months)
Secondary	Mental Health Continuum - Short Form (MHC-SF)	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.	Baseline (T0), end of treatment (T1)(one week after the last intervention session), follow-up (T2 at 6 months)
Secondary	Plymouth Sensory Imagery Questionnaire (PsiQ-NL-35)	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).	Baseline (T0)