Objective: The current study will explore the interaction between these two client characteristics, treatment response and treatment outcome in CBT and EFT, to determine whether patients* pre-treatment affect regulation capacity and level of…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
depressieve stemmingsstoornissen en afwijkingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Beck Depression Inventory (BDI). This self-report inventory assesses symptoms
of depression (Beck et al., 1996; Brouwer et al., 2013; Cole et al., 2003;
Kjærgaard et al., 2014; Wang & Gorenstein, 2013; Dutch version: Van der Does,
A. J. W., 2002).
State-Trait Anxiety Inventory (STAI). This is a self-report measure assessing
how respondents feel in general (Spielberger, 1983; Spielberger et al., 1989;
Barnes et al., 2002; Dutch version: van der Ploeg, H. M., 1980).
Difficulties in Emotion Regulation Scale (DERS). This scale provides an
assessment of emotion dysregulation Gratz & Roemer, 2004; Dutch version:
Neumann, A., van Lier, Pol A. C., Gratz, K. L., & Koot, H. M., 2010).
Attachment Style Questionnaire (ASQ). The ASQ is a 40-item self-report
questionnaire assessing five styles of adult attachment: one securely attached
style, confidence (in self and others), and four insecurely attached styles,
discomfort with closeness, need for approval, preoccupation with relationships,
and relationships as secondary (to achievement) (Feeney, Noller, & Hanranhan,
1994; Dutch Version: van Oudenhoven, J. P., Hofstra, J., & Bakker, W., 2003).
Secondary outcome
General Outcome Measures
Outcome Quiestionnaire-45.2 (OQ-45.2). This self-report measure provides an
index of mental health functioning and most items, the subscales, and the Total
Score are sensitive to the effects of interventions while remaining stable in
untreated individuals (Lambert et al, 2013; Dutch version: Amble, I., Gude, T.,
Stubdal, S., Oktedalen, T., Skjorten, A. M., Andersen, B. J., . . . Wampold, B.
E., 2014).
Rosenberg Self-esteem Inventory (RSE). The RSE is a 10-item self-report
questionnaire, rated 1-5, used to measure self-esteem (Rosenberg, 1965; Dutch
version: Franck, E., de Raedt, R., Barbez, C., & Rosseel, Y., 2008).
Secondary Outome Measure for MDD
Dysfunctional Attitudes Scale (DAS). The DAS is a 17-item, self-report
inventory, rated 1 to 7, developed to identify pervasive negative attitudes
toward self, outside world, and future that may relate to or cause depression
(Weissman & Beck, 1978; Dutch version: Raes, F., Hermans, D., Van den Broeck,
K., & Eelen, P., 2005).
Secondary Outome Measure for GAD
Penn State Worry Questionnaire (PSWQ). This is a self-report measure designed
to measure the trait of worry (Meyer et al., 1990; Dutch version: van der
Heiden, C., Muris, P., Bos, A. E., & van der Molen, H. T., 2010).
Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report inventory
assessing severity of anxiety in adults focusing on somatic symptoms (Beck,
Epstein, Brown, & Steer, 1988; Dutch version: Muntingh, A.D.T., van der
Feltz-Cornelis, C.M., van Marwijk, H.W.J., Spinhoven, P., Penninx, B.W.J.H.,
van Balkom, A.J.L.M., 2011).
Post-Session Measures
Client Task Specific Change Measure * Revised (CTSC-R). The CTSC-R is a 12-item
client self-report measure of client change (Greenberg, Rice, & Watson, 1996;
Watson, Greenberg, Rice & Gordon, 1999).
Working Alliance Inventory-Short Form (WAI-S). The WAI-S (Tracey & Kokotovic,
1989; Dutch version: Stinckens, N., Ulburghs, A., & Claes, L., 2009) is a
12-item self-report questionnaire, rated 1 to 7, derived from Bordin*s (1979)
conceptualization of the working alliance consisting of agreement on tasks and
goals, as well as the therapeutic bond.
Barrett-Lennard Relationship Inventory (BLRI). This is a self-report measure
used to rate Rogers* relationship conditions (Barrett-Lennard, 1962, 1978;
Dutch version: Leitaer, 1976).
Background summary
Rationale: MDD and GAD are major health problems that seriously compromise
functioning with high social and economic costs (Chisholm et al., 2016;
Greenberg et al., 2015; Revicki et al., 2012; Wittchen et al., 2011). Effective
treatment of these disorders has a direct potential benefit of reducing health
care expenses (Chisholm et al., 2016). While a number of treatments are
effective in the treatment of these disorders, some patients, up to 5% to 10%,
deteriorate in treatment in both clinical trials and routine care (Hansen et
al., 2002; Lambert & Ogles, 2004). Researchers have suggested the need to
identify specific moderators of patients* treatment response. Two client
characterisitics that have been shown to be important in treatment outcomes are
affect regulation and attachment insecurity (McBride, Atkinson, Quilty & Bagby,
2006; Mennin et al, 2009).
Study objective
Objective: The current study will explore the interaction between these two
client characteristics, treatment response and treatment outcome in CBT and
EFT, to determine whether patients* pre-treatment affect regulation capacity
and level of attachment insecurity interact with treatment type to influence
outcome.
Study design
This study will investigate the aptitude by treatment interaction using HLM and
a parallel study design.
To assess the role of patients* affect regulation capacity and attachment
insecurity as moderators of treatment response in CBT and EFT for MDD & GAD,
hierarchical linear mixed models (HLM) will be conducted using patients BDI and
STAI-T scores respectively. It is expected that there will be no differences in
outcome overall between CBT & EFT for MDD or GAD, but it is expected that
patients with higher DERS scores indicating greater problems regulating affect
and or higher attachment insecurity on the ASQ will do better in EFT than CBT.
Intervention
Intervention
Emotion Focused Psychotherapy (EFT; Elliott, Watson, Goldman & Greenberg, 2004;
Greenberg & Watson, 2006;, Watson & Greenberg; 2017) and Cognitive Behavioral
Therapy (CBT; Beck & Emery, 1985) are the two treatment interventions based on
the relevant treatment manuals for each approach.
Study burden and risks
There are no additional psychological or physical risks associated with
participating in the study beyond those that would be expected from engaging in
treatment as usual. Some participants may experience some distress and fatigue
answering questions about their psychological functioning. Patients will have
the support of their therapist to address these issues as well as the option to
withdraw from the research at any time and remain in treatment or request an
alternative treatment. Overall, it is expected that participants will benefit
from treatment and that the study will provide valuable information to guide
treatment delivery for those suffering from GAD and MDD to enhance treatment
effectiveness.
Bloor Street West Toronto 252
Toronto M5S 1V6
CA
Bloor Street West Toronto 252
Toronto M5S 1V6
CA
Listed location countries
Age
Inclusion criteria
Patients diagnosed with MDD or GAD between the ages of 18-65.
Exclusion criteria
Patients diagnosed with psychosis, addictions, at risk of suicide, metally retarded, or diagnosed with cluster A and severe Cluster B personality disorders.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59481.015.16 |