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SETA trial

Self-Esteem Treatment in Anxiety - positive versus negative memory representations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26034
Enrollment
60
Registered
2014-02-19
Start date
2014-05-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety disorders Self-esteem Angststoornissen Zelfbeeld Zelfwaardering

Interventions

The two study allocations will receive this order of treatment modules: 1. First EMDR second method (6 sessions in 6-8 weeks) and then COMET (6 sessions in 6-8 weeks) 2. First COMET ((6 sessions in
Engelhard 2012
van den Hout, Rijkeboer, Engelhard et al., 2012). EMDR desensitizes vivid mental representations with negative emotionality (Shapiro n.d.). By using EMDR, these representations get reduced in their vi
Korrelboom, Maarsingh, & Huijbrechts, 2012
Korrelboom, Marissen, & van Assendelft, 2011
van der Gaag, van Oosterhout, Daalman, Sommer, & Korrelboom, 2012). COMET uses positive memories that encompass ‘counter-themes’ of the current negative self-imag

Sponsors

University of Utrecht, The Netherlands. Prof. Dr. I Engelhard.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: People with a primary anxiety disorder according to the DSM-IV, possibly more than one anxiety disorder, co-morbid depression and/or other co-morbid symptoms. So co-morbidity is not an exclusion criterion. Further inclusion criteria are: – An anxiety disorder, based on a structured DSM-IV interview – Low self-esteem (< 26 on the Rosenberg Self-esteem scale) – For one month or more: no changes in psychopharmacological medications – Mastery of the Dutch language, in order to be able to fill out the questionnaires – Able to mention at least one positive aspect within his/her self-image, which does not need to be felt or be completely convincing At Altrecht psychiatric institute, there is an extra inclusion criterion: the anxiety disorder has been treated for at least 12 sessions with regular evidence-based therapy. Despite this, anxiety symptoms are still present in the psychopathological level, as shows by scoring 39 or higher on the state part of the STAI instrument (Julian, 2011). Thus, the disorder has not responded well enough to regular treatment. At the other participating institution, PsyQ, this criterion is not applied. There, patients may participate in the study right after intake procedure. This difference is a consequence of available patients groups and the vision of therapists and researchers of both institutions. However, despite the fact that the selected patient groups will not be completely comparable, a broader population will enter the study this way, which has benefits. And it is not the goal to compare the two institutions.

Exclusion criteria

Exclusion criteria: – Drug abuse or dependance according to DSM-IV criteria

Design outcomes

Primary

MeasureTime frame
Self-esteem. This will first of all be measured using the Rosenberg Self-esteem Scale. This is a frequently used scale within self-esteem studies all over the world (Schmitt & Allik, 2005), and the revised version has a somewhat better construct validity than the original version, although both are equally reliable (Wongpakaran, Tinakon, Wongpakaran, & Nahathai, 2012). In the Netherlands, an average score of 31.6 has been found (SD=4.5) within a healthy population, and we will apply the cut-off of 26 for inclusion in our study (one standard deviation below average) (Schmitt & Allik, 2005). Also, we will use the Self-Esteem Rating Scale - Short Form (SERS-SF), as this instrument measures negative as well as positive subdomains of self-esteem in a valid way (Lecomte, Corbière, & Laisné, 2006). Anxiety symptoms. For this we will use the Dutch version of the Spielberger State-Trait Anxiety Inventory (STAI). It consists of two subscales with each twenty 4-option items. It measures anxiety as a condition as well as anxiety as a trait of personality. The STAI has been validated, for example in the light of DSM-IV anxiety disorder symptoms (Okun, Stein, Bauman, & Silver, 1996). A cut-off score of 39 can be used for the state part of the scale, indicating psychopathology (Julian, 2011).

Secondary

MeasureTime frame
Depressed mood. We will use the Beck Depression Inventory II (BDI 2) (Beck, Steer, & Brown, 1996; Beck, Steer, & Garbin, 1988). This self administered scale consists of 21 items that are each scored from 0 to 3. The total score ranges from 0 to 63, with higher scores indicating more depressed mood. General psychopathology. For this, the Brief Symptom Inventory (BSI) will be used. This is a short version of the SCL-90. It is a self-administered scale that measures somatic and psychological symptoms for screening general psychopathology. The questionnaire consists of 53 symptom descriptions for which the patient rates the burden in the past week. The BSI has nine subscales. The total score indicates the general level over psychological/physical burden. A five-point scale is used for each item, ranging from ‘not at all’ to ‘very much’. The scale with its subdomains is valid and reliable (Morlan ea, 1998). Finally, we will measure treatment preference within the therapists, and use this as a covariatein the analysis. Possible, preference makes a difference, and it is useful to account for this effect.

Contacts

Public ContactA.B.P. Staring

Altrecht Psychiatric Institute Mimosastraat 2

t.staring@altrecht.nl+31(0)30-3103100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)