Improve: Integrating Emotion Focused Components Into Psychological Therapy

NCT ID: NCT02822443

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-08-31

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).

Conditions

Unipolar Depression; Anxiety Disorder; Adjustment Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 - 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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franz Caspar, Prof. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bern, Switzerland

Locations

University of Bern

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 27881113 (View on PubMed)

Other Identifiers

SNF100019_159425 /1

Identifier Type: -

Identifier Source: org_study_id