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Completed

NCT Number: NCT02822443

Improve: Integrating Emotion Focused Components Into Psychological Therapy

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.

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Key information

Conditions

Unipolar Depression Adjustment Disorder Adjustment Disorders Anxiety Disorder Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Bern

Bern, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)

Behavioral

25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions.

Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Personality traits measured by the Inventory of Personality Organization (IPO-16; Zimmermann et al., 2013)

    Time frame: Baseline

  12. 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

  13. 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

  14. 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

  15. 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

  16. General self-efficacy measured by the General Self-Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999)

    Time frame: Baseline, end of therapy after 25 weeks

  17. Therapy evaluation and outcome expectancies measured by the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005)

    Time frame: Baseline

  18. Social desirability measured by the Balanced Inventory of Desirable Responding (BIDR-K; Winkler et al., 2006)

    Time frame: Baseline

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. Symptom impairment measured by the Symptom Checklist (SCL-9; Bogerts et al., 2001)

    Time frame: Weekly until 25 weeks

  26. Implicit motives measured by the Picture-Story-Exercise - Online Version (PSE-O: Bernecker & Jobst, 2013)

    Time frame: Baseline, end of therapy after 25 weeks

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

The Impact of Integrating Emotion Focused Components Into Psychological Therapy

Acronym: Improve

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jul 4, 2016
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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