NCT04690946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

December 16, 2020

Last Update Submit

March 25, 2026

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Change in Beck Depression Inventory from session to session

    Self-report measure of depressive symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.

    1 week before treatment startup, 1 day after each therapy session, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up

Secondary Outcomes (9)

  • Change in Beck Anxiety Inventory

    1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up

  • Change in Repetitive Eating Questionnaire

    1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up

  • Change in Inventory of Interpersonal problems

    1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up

  • Change in The Acceptance and Action Questionnaire from session to session

    1 week before treatment startup, 1 day after each therapy session, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up

  • Change in Emotion Approach Coping Scale

    1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up

  • +4 more secondary outcomes

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy

Emotion-Focused Therapy

ACTIVE COMPARATOR

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

Behavioral: Emotion-Focused Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

14-18 sessions of CBT

Also known as: CBT
Cognitive Behavioral Therapy
Emotion-Focused TherapyBEHAVIORAL

14-18 sessions of EFT

Also known as: EFT
Emotion-Focused Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Moderate or major depressive episode as primary diagnosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutt for Psykologisk rådgivning

Bergen, Bergen, 5012, Norway

Location

Related Publications (17)

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

    PMID: 20063907BACKGROUND

  • 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.

    PMID: 19583884BACKGROUND

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

    PMID: 20099202BACKGROUND

  • 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.

    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.

    PMID: 12924682BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 19034715BACKGROUND

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

    PMID: 22082384BACKGROUND

  • 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.

    PMID: 12642531BACKGROUND

  • 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.

    BACKGROUND

  • What have we learned about treatment failure in empirically supported treatments

    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

    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.

    BACKGROUND

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

    BACKGROUND

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

    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.

    PMID: 29466928BACKGROUND

  • Aardal H, Schanche E, Hjeltnes A, Danielsen YS, Bjerregaard Bertelsen T, Zahl-Olsen R, Stiegler JR. 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.

    PMID: 41031587DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral TherapyEmotion-Focused Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan Reidar Stiegler, PhD

    Institute for Psychological Counselling

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 31, 2020

Study Start

January 20, 2021

Primary Completion

July 30, 2024

Study Completion

January 30, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)