Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression

NCT ID: NCT04690946

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2025-03-30

Brief Summary

Depression is a common mental illness which is costly for both society and for those affected. There is a need for effective treatments of depression and there is a need to make sure that the treatments that are given are based on scientific findings. In this study the investigators want to examine and compare two common treatment models for depression - Cognitive Behavioral Therapy and Emotion-Focused Therapy. The investigators want to investigate what characterizes these treatments when they are successful, and seek to better understand what it is like for patients to receive these treatments. Also, the investigators will investigate the experience of patients who abruptly discontinue treatment. To investigate these questions, self-report measures, interviews and analysis of session recordings will be used.

Detailed Description

Depression is a widespread mental disorder which can result in severe impairment and reduced quality of life for those affected. Cognitive behavioral therapy (CBT) is the approach with strongest empirical support, and is often recommended as treatment for depression, as in the NICE Guidelines for Depression from 2009. However, research indicates that not all patients respond to CBT, indicating a need to expand the range of available evidence-based psychotherapies, and mapping the mechanisms of change in existing treatments.

Emotion focused therapy (EFT) is one promising treatment for depression with empirical support for its efficacy. A previous study found equal outcome in CBT and Process-Experiential treatment/EFT for depression, but more studies are needed to replicate these findings across cultural contexts. The main aim of this study is to investigate whether there are significant differences in the therapeutic effect of EFT compared to that of CBT for patients with moderate and major depressive disorder in a Norwegian outpatient setting.

Although several psychotherapeutic approaches have shown efficacy in the treatment of depression, no psychotherapeutic interventions is beneficial for all patients. There is a need for research that investigates what treatments works for whom, based on patient characteristics and preferences. The present study will investigate whether patient characteristics moderate treatment outcome, both within and between treatment conditions. In addition, qualitative interviews will be conducted to get a deeper understanding of what clients find helpful and challenging within the CBT and EFT condition, and to explore the experience of patients who drop-out of the treatment process.

In order to further develop psychotherapeutic treatments and increase their effectiveness, there is a need to identify processes that are related to good and poor outcome. Process-outcome studies are commonly used for this purpose. The present study will investigate and compare characteristics of psychotherapy processes in both the CBT and EFT conditions and how these are related to outcome.

Study design and Method

The study will be conducted as a randomized controlled trial (RCT) in order to compare the efficacy of EFT to CBT. RCT's are considered the gold standard for efficacy studies. Participants will be recruited from the Norwegian mental health program "Return to work", a publicly funded treatment program where patients with common mental health issues receives outpatient psychotherapeutic treatment to reduce and prevent sick leave.

The present study will address the following research hypothesis and questions:

1. EFT and CBT will not result in significantly different outcome in the treatment of patients with moderate and major depressive disorder.

2. Patient characteristics (severity of depression, adverse childhood experiences and clients' initial ability to make sense of their experience) will moderate treatment outcome for both conditions.

3. Will therapeutic processes (therapeutic alliance, therapist empathy, clients' ability to make sense of their experience and emotional processing) mediate treatment outcome equally for both conditions?

4. What do patients in both conditions describe as helpful and unhelpful aspects of treatment?

5. How do patients in both conditions describe their own change or lack or change after treatment?

6. How do patients that choose to drop out of treatment describe the processes leading to that decision?

Conditions

Depression

Study Design

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

Study Groups

Cognitive Behavioral Therapy

14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

14-18 sessions of CBT

Emotion-Focused Therapy

14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy

Group Type: ACTIVE_COMPARATOR

Emotion-Focused Therapy

Intervention Type: BEHAVIORAL

14-18 sessions of EFT

Interventions

Cognitive Behavioral Therapy

14-18 sessions of CBT

Intervention Type: BEHAVIORAL

Emotion-Focused Therapy

14-18 sessions of EFT

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; EFT

Eligibility Criteria

Inclusion Criteria

• Moderate or major depressive episode as primary diagnosis

Exclusion Criteria

• Serious mental illness (schizophrenia, severe bipolar disorder, recent or current psychotic episode) or intellectual disability.
• Severe alcohol or drug abuse, last 12 months.
• Suicidality last 6 months
• Severe medical issues
• If the participant is on antidepressive medication, the dosage must have been stable for more than 4 weeks, and the participant must consent to staying on the same dosage for the duration of the treatment.
• The participant is currently in another treatment for depression

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

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Institutt for Psykologisk Radgivning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Reidar Stiegler, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Psychological Counselling

Locations

Institutt for Psykologisk rådgivning

Bergen, , Norway

Countries

Norway

References

Dimidjian S, Hollon SD. How would we know if psychotherapy were harmful? Am Psychol. 2010 Jan;65(1):21-33. doi: 10.1037/a0017299.

Reference Type: BACKGROUND

PMID: 20063907 (View on PubMed)

Blatt SJ, Luyten P. A structural-developmental psychodynamic approach to psychopathology: two polarities of experience across the life span. Dev Psychopathol. 2009 Summer;21(3):793-814. doi: 10.1017/S0954579409000431.

Reference Type: BACKGROUND

PMID: 19583884 (View on PubMed)

Elliott R. Psychotherapy change process research: realizing the promise. Psychother Res. 2010 Mar;20(2):123-35. doi: 10.1080/10503300903470743.

Reference Type: BACKGROUND

PMID: 20099202 (View on PubMed)

Goldman, R. N., Greenberg, L. S., & Angus, L. (2006). The effects of adding emotion-focused interventions to the client-centered relationship conditions in the treatment of depression. Psychotherapy Research, 16(5), 537-549.

Reference Type: BACKGROUND

Watson JC, Gordon LB, Stermac L, Kalogerakos F, Steckley P. Comparing the effectiveness of process-experiential with cognitive-behavioral psychotherapy in the treatment of depression. J Consult Clin Psychol. 2003 Aug;71(4):773-81. doi: 10.1037/0022-006x.71.4.773.

Reference Type: BACKGROUND

PMID: 12924682 (View on PubMed)

Greenberg, L & Watson, J. (1998). Experiential Therapy of Depression: Differential Effects of ClientCentered Relationship Conditions and Process Experiential Interventions, Psychotherapy Research, 8:2, 210-224.

Reference Type: BACKGROUND

Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.

Reference Type: BACKGROUND

PMID: 19034715 (View on PubMed)

Kazdin AE. Evidence-based treatment research: Advances, limitations, and next steps. Am Psychol. 2011 Nov;66(8):685-698. doi: 10.1037/a0024975.

Reference Type: BACKGROUND

PMID: 22082384 (View on PubMed)

Kendall JM. Designing a research project: randomised controlled trials and their principles. Emerg Med J. 2003 Mar;20(2):164-8. doi: 10.1136/emj.20.2.164. No abstract available.

Reference Type: BACKGROUND

PMID: 12642531 (View on PubMed)

Lambert, M. J. (2011). What have we learned about treatment failure in empirically supported treatments? Some suggestions for practice. Cognitive and Behavioral Practice, 18(3), 413-420.

Reference Type: BACKGROUND

What have we learned about treatment failure in empirically supported treatments

Reference Type: BACKGROUND

NICE (2009a). Depression: Treatment and Management of Depression in Adults. Clinical Guideline 90. London: National Institute for Health and Clinical Excellence. Available at www.nice.org.uk

Reference Type: BACKGROUND

Nilsson, T., Svensson, M., Sandell, R. & Clinton, D. (2007). Patients' experiences of change in cognitive-behavioral therapy and psychodynamic therapy: a qualitative comparative study. Psychotherapy Research, 17:5, 553-566.

Reference Type: BACKGROUND

Rice, L. N., & Greenberg, L. S. (Eds.). (1984). Patterns of change: Intensive analysis of psychotherapy process. Guilford Press.

Reference Type: BACKGROUND

Roth, A & Fonagy, P (1996) What works for whom? New York: Guilford Press

Reference Type: BACKGROUND

Watson JC. Mapping patterns of change in emotion-focused psychotherapy: Implications for theory, research, practice, and training. Psychother Res. 2018 May;28(3):389-405. doi: 10.1080/10503307.2018.1435920. Epub 2018 Feb 21.

Reference Type: BACKGROUND

PMID: 29466928 (View on PubMed)

Aardal H, Schanche E, Hjeltnes A, Danielsen YS. Cognitive behavioral therapy and emotion-focused therapy for depression in a routine care setting: A randomized controlled pilot trial. Psychother Res. 2025 Oct 1:1-15. doi: 10.1080/10503307.2025.2560935. Online ahead of print.

Reference Type: DERIVED

PMID: 41031587 (View on PubMed)

Provided Documents

Document Type: Study Protocol

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Other Identifiers

IPR

Identifier Type: -

Identifier Source: org_study_id