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

Primary Purpose

Unipolar Depression, Anxiety Disorder, Adjustment Disorder

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)
Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAU - EFT

TAU - SR

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in symptom impairment measured by the Brief Symptom Inventory (BSI; Franke, 2000)
Change from baseline in depressive symptoms measured by the Beck Depression Inventory (BDI-II; Hautzinger et al., 2006)
Change from baseline in anxiety symptoms measured by the Beck Anxiety Inventory (BAI; Ehlers & Margraf, 2007)

Secondary Outcome Measures

Severity of panic disorder and agoraphobia with the Panic and Agoraphobia Scale (PAS; Bandelow, 1997)
Severity of social phobia measured by the Social Phobia Scale SPS; Stangier et al., 1999)
Severity of social interaction anxiety measured by the Social Interaction Anxiety Scale (SIAS; Stangier et al., 1999)
Severity of anxiety symptoms measured by the Questionnaire for General Anxiety Disorder (GAD-7; Spitzer et al., 2006)
Psychological well-being measured with the WHO Well-Being Index (WHO-5; Henkel et al., 2004)
Health-related quality of life measured with the Short Form Healthy Survey (SF-12; Gandek et al., 1998)
Motivational schemata measured by the Questionnaire for Analysis of Motivational Schemata (FAMOS; grosse Holtforth & Grawe, 2000)
Motivational incongruence measured by the Incongruence Questionnaire (K-INK; grosse Holtforth et al., 2003)
Interpersonal problems measured by the Inventory of Interpersonal Problems (IIP-32; Thomas et al., 2011)
Personality structure measured by the Operationalized Psychodynamic Diagnosis Structure Questionnaire (OPD-SFK; Ehrenthal et al., 2012)
Personality traits measured by the Inventory of Personality Organization (IPO-16; Zimmermann et al., 2013)
Ambivalence over emotional expressiveness measured by the Ambivalence over the Expression of Emotion Scale (AVEX; Trachsel et al., 2010)
Emotional competency measured by the Questionnaire for the self-assessment of emotional competencies (SEK-27; Berking & Znoj, 2008)
Generalized expectancies for negative mood regulation measured by the Negative Mood Regulation Scale (NMR-SF; Pfeiffer et al., 2013)
Psychological flexibility measured by the Acceptance and Action Questionnaire (Fragebogen zu Akzeptanz und Handeln; FAH-II; Gloster et al., 2013)
General self-efficacy measured by the General Self-Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999)
Therapy evaluation and outcome expectancies measured by the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005)
Social desirability measured by the Balanced Inventory of Desirable Responding (BIDR-K; Winkler et al., 2006)
Client satisfaction measured by the Brief Global Measure of Client Satisfaction (ZUF-8; Schmidt & Wittmann, 2002)
External assessment of interpersonal personality measured by the Impact Message Inventory (IMI-R; Caspar et al. 2002)
External assessment of resources measured by the Bernese Inventory of Resources (REF-F and REF-T; Tröske, 2000)
External assessment of positive interpersonal qualities measured by the Inventory of Interpersonal Strengths (IIS; Hatcher & Rogers, 2012)
Goal attainment measured by the Goal Attainment Scaling (GAS; Kirusek, 1994)
Regular quality monitoring with the Bern Post Session Report, Patient and Therapist Version (BPSR-P/T; Flückiger et al. 2010)
Symptom impairment measured by the Symptom Checklist (SCL-9; Bogerts et al., 2001)
Implicit motives measured by the Picture-Story-Exercise - Online Version (PSE-O: Bernecker & Jobst, 2013)

Full Information

First Posted
June 22, 2016
Last Updated
September 9, 2019
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02822443
Brief Title
Improve: Integrating Emotion Focused Components Into Psychological Therapy
Acronym
Improve
Official Title
The Impact of Integrating Emotion Focused Components Into Psychological Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression, Anxiety Disorder, Adjustment Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU - EFT
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU - SR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)
Intervention Description
25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions.
Intervention Type
Behavioral
Intervention Name(s)
Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)
Intervention Description
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 Outcome Measure Information:
Title
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
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Personality traits measured by the Inventory of Personality Organization (IPO-16; Zimmermann et al., 2013)
Time Frame
Baseline
Title
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
Title
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
Title
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
Title
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
Title
General self-efficacy measured by the General Self-Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999)
Time Frame
Baseline, end of therapy after 25 weeks
Title
Therapy evaluation and outcome expectancies measured by the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV; Schulte, 2005)
Time Frame
Baseline
Title
Social desirability measured by the Balanced Inventory of Desirable Responding (BIDR-K; Winkler et al., 2006)
Time Frame
Baseline
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Symptom impairment measured by the Symptom Checklist (SCL-9; Bogerts et al., 2001)
Time Frame
Weekly until 25 weeks
Title
Implicit motives measured by the Picture-Story-Exercise - Online Version (PSE-O: Bernecker & Jobst, 2013)
Time Frame
Baseline, end of therapy after 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franz Caspar, Prof. PhD
Organizational Affiliation
University of Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27881113
Citation
Babl A, Grosse Holtforth M, Heer S, Lin M, Stahli A, Holstein D, Belz M, Egenolf Y, Frischknecht E, Ramseyer F, Regli D, Schmied E, Fluckiger C, Brodbeck J, Berger T, Caspar F. Psychotherapy integration under scrutiny: investigating the impact of integrating emotion-focused components into a CBT-based approach: a study protocol of a randomized controlled trial. BMC Psychiatry. 2016 Nov 24;16(1):423. doi: 10.1186/s12888-016-1136-7.
Results Reference
derived

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Improve: Integrating Emotion Focused Components Into Psychological Therapy

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