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Improve: Integrating Emotion Focused Components Into Psychological Therapy (Improve)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Bern
Sponsor:
Information provided by (Responsible Party):
University of Bern
ClinicalTrials.gov Identifier:
NCT02822443
First received: June 22, 2016
Last updated: July 1, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Unipolar Depression
Anxiety Disorder
Adjustment Disorder
Behavioral: Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)
Behavioral: Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Integrating Emotion Focused Components Into Psychological Therapy

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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, after 16 weeks, end of therapy after 25 weeks, 6 months follow-up, 12 months follow-up and 36 months follow-up ]
  • Regular quality monitoring with the Bern Post Session Report, Patient and Therapist Version (BPSR-P/T; Flückiger et al. 2010) [ Time Frame: Weekly until 25 weeks ]
  • Symptom impairment measured by the Symptom Checklist (SCL-9; Bogerts et al., 2001) [ Time Frame: Weekly until 25 weeks ]
  • Implicit motives measured by the Picture-Story-Exercise - Online Version (PSE-O: Bernecker & Jobst, 2013) [ Time Frame: Baseline, end of therapy after 25 weeks ]

Estimated Enrollment: 130
Study Start Date: April 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAU - EFT
This arm integrates emotion focused components (EFT; Greenberg, 2010) into psychological therapy (PT) as treatment-as-usual (TAU), aiming at clarifying and transforming maladaptive emotions. 25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions.
Behavioral: Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)
25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions.
Experimental: TAU - SR
This arm focuses on the training of self-regulation strategies (SR; Carver & Scheier, 2000) in the context of psychological therapy (PT) as treatment-as-usual (TAU). 25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions.
Behavioral: Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)
25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major Depressive Disorder, Anxiety Disorder or Adjustment Disorder according to DSM-IV as main diagnosis
  • Minimum age of 18 years
  • Mastery of the German language for being able to undergo a psychotherapy in German
  • Written informed consent to participate voluntary in the study

Exclusion Criteria:

  • Acute suicidality or immediate threats of self-harm
  • Diagnosis or history of a psychotic disorder
  • Mood incongruent psychotic symptoms
  • Bipolar disorder
  • Comorbid chronic organic disorder
  • Substance use disorder as a main diagnosis
  • Indication for a residential treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02822443

Contacts
Contact: Franz Caspar, Prof. PhD +41 31 631 47 31 franz.caspar@psy.unibe.ch

Locations
Switzerland
University of Bern Recruiting
Bern, Switzerland
Contact: Franz Caspar, Prof. PhD    +41 31 631 47 31    franz.caspar@psy.unibe.ch   
Principal Investigator: Franz Caspar, Prof. PhD         
Sub-Investigator: Thomas Berger, Prof. PhD         
Sub-Investigator: Martin grosse Holtforth, Prof. PhD         
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Franz Caspar, Prof. PhD University of Bern, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02822443     History of Changes
Other Study ID Numbers: SNF100019_159425 /1
Study First Received: June 22, 2016
Last Updated: July 1, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Adjustment Disorders
Depressive Disorder
Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Mood Disorders

ClinicalTrials.gov processed this record on May 24, 2017