Improve: Integrating Emotion Focused Components Into Psychological Therapy

NCT02822443 | Completed Phase 2 DMC

• 1 other identifier: SNF100019_159425 /1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Unipolar Depression; Anxiety Disorder; Adjustment Disorder

Outcome Measures

Primary Outcomes (3)

• Change from baseline in symptom impairment measured by the Brief Symptom Inventory (BSI; Franke, 2000)

  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)

  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)

  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 (26)

• Severity of panic disorder and agoraphobia with the Panic and Agoraphobia Scale (PAS; Bandelow, 1997)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

TAU - EFT

EXPERIMENTAL

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)

TAU - SR

EXPERIMENTAL

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)

Interventions

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.

TAU - EFT

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

TAU - SR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern

Bern, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27881113 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Adjustment Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Trauma and Stressor Related Disorders

Study Officials

• Franz Caspar, Prof. PhD

  University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 4, 2016
• Study Start: April 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)