Clinical Trial: Improve: Integrating Emotion Focused Components Into Psychological Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Impact of Integrating Emotion Focused Components Into Psychological Therapy

Brief Summary: The primary purpose of this study is to compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of emotion focused components (EFT) and TAU with focus on self-regulation (SR). Especially the long-term efficacy is evaluated with a focus on differential effects. Moreover, the mechanisms of change of both conditions are investigated.

Detailed Summary:

Background:

"General Psychotherapy" postulates an ongoing process of including all interventions and concepts relevant for a domain, be they from other approaches to psychotherapy or concepts from basic science. "Psychological Therapy" (PT) is a therapeutic approach largely corresponding to the ideas of General Psychotherapy. It draws mainly on empirically validated interventions from Cognitive Behavior Therapy (CBT) and is based on concepts with a strong basis in academic psychology and neighboring fields. PT is based on explicit individual case conceptualization, reference to general therapeutic factors, and an explicit prescriptive concept for building and maintaining the therapeutic relationship. However the range of emotion-related interventions commonly used in PT is limited when compared with an approach like Emotion Focused Therapy (EFT). EFT appears thus as a suitable complement and enrichment to PT as commonly practiced. However, effects of integrating EFT-based interventions in a way that is close to common integrative practice have not yet been studied.

Objective:

To compare the efficacy of two treatment-as-usual (TAU) conditions: TAU with integration of EFT components and TAU with focus on self-regulation (SR).

Methods:

In Switzerland, a randomized-controlled trail will be carried out in secondary care, comparing the efficacy of TAU - EFT and TAU - SR for adults with major depressive disorder, anxiety disorder or adjustment disorder. Respondents will be followed until 36 months after end of therapy (measures will be taken at baseline, after 8 and after 16 weeks, at the end of therapy after 25 weeks, 6 months, 12 months and 36 months follow-up)
Sponsor: University of Bern

Current Primary Outcome:

  • Change from baseline in symptom impairment measured by the Brief Symptom Inventory (BSI; Franke, 2000) [ Time Frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Change from baseline in depressive symptoms measured by the Beck Depression Inventory (BDI-II; Hautzinger et al., 2006) [ Time Frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Change from baseline in anxiety symptoms measured by the Beck Anxiety Inventory (BAI; Ehlers & Margraf, 2007) [ Time Frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Severity of panic disorder and agoraphobia with the Panic and Agoraphobia Scale (PAS; Bandelow, 1997) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Severity of social phobia measured by the Social Phobia Scale SPS; Stangier et al., 1999) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Severity of social interaction anxiety measured by the Social Interaction Anxiety Scale (SIAS; Stangier et al., 1999) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Severity of anxiety symptoms measured by the Questionnaire for General Anxiety Disorder (GAD-7; Spitzer et al., 2006) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Psychological well-being measured with the WHO Well-Being Index (WHO-5; Henkel et al., 2004) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Health-related quality of life measured with the Short Form Healthy Survey (SF-12; Gandek et al., 1998) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Motivational schemata measured by the Questionnaire for Analysis of Motivational Schemata (FAMOS; grosse Holtforth & Grawe, 2000) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Motivational incongruence measured by the Incongruence Questionnaire (K-INK; grosse Holtforth et al., 2003) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Interpersonal problems measured by the Inventory of Interpersonal Problems (IIP-32; Thomas et al., 2011) [ Time Frame: Baseline, after 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Personality structure measured by the Operationalized Psychodynamic Diagnosis Structure Questionnaire (OPD-SFK; Ehrenthal et al., 2012) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Personality traits measured by the Inventory of Personality Organization (IPO-16; Zimmermann et al., 2013) [ Time Frame: Baseline ]
  • Ambivalence over emotional expressiveness measured by the Ambivalence over the Expression of Emotion Scale (AVEX; Trachsel et al., 2010) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Emotional competency measured by the Questionnaire for the self-assessment of emotional competencies (SEK-27; Berking & Znoj, 2008) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Generalized expectancies for negative mood regulation measured by the Negative Mood Regulation Scale (NMR-SF; Pfeiffer et al., 2013) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Psychological flexibility measured by the Acceptance and Action Questionnaire (Fragebogen zu Akzeptanz und Handeln; FAH-II; Gloster et al., 2013) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • General self-efficacy measured by the General Self-Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Therapy evaluation and outcome expectancies measured by the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005) [ Time Frame: Baseline ]
  • Social desirability measured by the Balanced Inventory of Desirable Responding (BIDR-K; Winkler et al., 2006) [ Time Frame: Baseline ]
  • Client satisfaction measured by the Brief Global Measure of Client Satisfaction (ZUF-8; Schmidt & Wittmann, 2002) [ Time Frame: After 8 weeks, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • External assessment of interpersonal personality measured by the Impact Message Inventory (IMI-R; Caspar et al. 2002) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • External assessment of resources measured by the Bernese Inventory of Resources (REF-F and REF-T; Tröske, 2000) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • External assessment of positive interpersonal qualities measured by the Inventory of Interpersonal Strengths (IIS; Hatcher & Rogers, 2012) [ Time Frame: Baseline, end of therapy after 25 weeks ]
  • Goal attainment measured by the Goal Attainment Scaling (GAS; Kirusek, 1994) [ Time Frame: After 8 weeks, af

    Original Secondary Outcome: Same as current

    Information By: University of Bern

    Dates:
    Date Received: June 22, 2016
    Date Started: April 2015
    Date Completion: March 2018
    Last Updated: July 1, 2016
    Last Verified: June 2016