|- candidate number||17961|
|- NTR Number||NTR4611|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mei-2014|
|- Secondary IDs||NL49421.044.14 |
|- Public Title||The effect of EMDR and CBT on low self-esteem, a randomized controlled trial|
|- Scientific Title||The effect of EMDR and CBT on low self-esteem, a randomized controlled trial|
|- hypothesis||The aim of the present study is to investigate whether EMDR is an effective method to treat low self-esteem and if this is more effective than CBT.
1. Participants will improve on measures of self-esteem, psychological symptoms and social interaction after treatment with EMDR
2. Participants will improve on measures of self-esteem, psychological symptoms and social interaction after treatment with CBT
3. Participants will show a larger improvement on measures of self-esteem, psychological symptoms and social interaction in the EMDR condition compared to the CBT condition
4. Participants will show a more rapid improvement on measures of self-esteem, psychological symptoms and social interaction in the EMDR condition compared to the CBT condition
5. Participants will show a larger improvement on measures of self-esteem, psychological symptoms and social interaction at 3 month follow-up in the EMDR condition compared to the CBT condition
|- Healt Condition(s) or Problem(s) studied||Self concept, EMDR, Cognitive behavior therapy|
|- Inclusion criteria||- Subjects are diagnosed with an axis I and/or an axis II disorder according to the
- Subjects are referred by their therapist to follow a self-esteem treatment group
- Subjects score beneath the cut-off point on the Rosenberg Self Esteem Scale
|- Exclusion criteria||- Subjects who score above the cut-off on the RSES |
- Subjects who are diagnosed with Post traumatic Stress Disorder
- Subjects who do not speak or can read the Dutch language
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2014|
|- planned closingdate||31-dec-2016|
|- Target number of participants||30|
|- Interventions||Subjects are randomly assigned to either the EMDR or the CBT condition.
Subjects receive 10 weekly sessions of 60 minutes each. Using the ‘Second method’ of case conceptualization described by De Jongh et al. (2010), 5 memories are identified that have led to the formation and perpetuation of the selected core belief. These memories so to speak subjectively “prove” that the belief is true. Subjects are asked to write down these memories in a few sentences. The memory that gives the most proof for the belief according to the subject will be selected first. The basic EMDR protocol will be started using this memory (De Jongh & Ten Broeke, 2003). When efficiently treated the next memory that gives the most prove will be selected and treated with the EMDR protocol. The duration of effectively treating one memory differs between individuals which means that it is possible not all of the 5 memories will be effectively treated or that all 5 memories are treated before ending the 10th session. All sessions are videotaped and evaluated by an independent EMDR supervisor.
Subjects receive cognitive behavioral group therapy based on a method described by De Neef (2010). The group consists of 10 participants maximum. They receive 10 weekly sessions of 120 minutes each including a 15 minute break. They receive information about low self-esteem and keep a diary where they write down positive events and positive qualities of themselves. Cognitive interventions are used to help subjects recognize positive events and to recognize and change negative and disfunctional thoughts. They further receive information and training about receiving critism, investigate pro’s and cons of negative thoughts and discuss how to prevent relapse. All sessions are videotaped and evaluated by an independent CBT supervisor.
|- Primary outcome||Score on the Rosenberg Self Esteem Scale (RSES).|
|- Secondary outcome||Score on the Brief Symptom Inventory (BSI)
Score on the ‘Inventarisatielijst Omgaan met Anderen’ (IOA)
Score on the VAS-score core beliefs measuring the credibility of the selected negative and positive core belief (0% credible- 100% credible)
|- Timepoints||Subjects are measured pre treatment, post treatment (after 10 weekly sessions) and at 3 month follow up|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| B.T. Griffioen|
|- CONTACT for SCIENTIFIC QUERIES|| B.T. Griffioen|
|- Sponsor/Initiator ||Dimence|
(Source(s) of Monetary or Material Support)
|Dimence, Vereniging EMDR Nederland (VEN)|
|- Brief summary||Rationale: Low self-esteem has a negative influence on psychological symptoms like depression and anxiety and can cause patients to relapse after treatment. Research indicates that low self-esteem can even be a causal factor in developing psychiatric disorders like depression and anxiety. For this reason treatment should be focused more on changing low self-esteem instead of only treating the DSM-IV disorder. Cognitive interventions that focus on learning patients to formulate more positive and realistic thoughts, seem to be effective, however a much heard complaint is that patients after treatment do ‘know’ that their negative thoughts about themselves are not true but that they don’t ‘feel’ better about themselves. It could be argued that Eye Movement and Desensitization and Reprocessing (EMDR) could lead to a better treatment result by treating the damaging events that are at the core of the low self-esteem. The fact that EMDR can lead to results in just a few sessions could even mean that EMDR is a more efficient and cost effective treatment for low self-esteem compared to cognitive behavioural therapy (CBT).|
Objective: Research indicates that EMDR is an effective treatment method for post traumatic stress disorder (PTSD) and several other disorders like depression and anxiety. So far little is known about the effects on low self-esteem. Several case studies indicate that EMDR could have a significant effect on changing low self esteem. Wanders et al (2008) performed a randomized controlled trial with adolescents and found evidence that EMDR was effective in treating low self-esteem. The current study focuses on treating adults with low self- esteem and will compare two therapeutic methods, namely EMDR and CBT, on their effectiveness and efficiency.
Study design: Randomized controlled trial, parallel groups
Study population: Patients between 18-65 years old diagnosed with an axis I and/or an axis II disorder according to the DSM-IV-TR who are indicated by their therapist to follow ‘Self esteem group therapy’, are approached to participate in the current study. Patients diagnosed with PTSD are excluded. Patients with a score beneath the cut-off on the Rosenberg Self Esteem Scale are included in the study.
Intervention (if applicable): Participants are randomly assigned to either the EMDR intervention or the CBT intervention. Participants in the EMDR condition receive 10 individual EMDR sessions weekly. Participants in the CBT condition receive 10 group sessions weekly.
Main study parameters/endpoints: The main study parameters are the changes in scores from baseline to endpoint on questionnaires measuring self-esteem, psychological symptoms and social interaction.
|- Main changes (audit trail)|
|- RECORD||26-mei-2014 - 22-jun-2014|