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| Name | Class |
|---|---|
| University of Bergen | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Active Comparator | 14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy |
|
| Emotion-Focused Therapy | Active Comparator | 14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 14-18 sessions of CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Anxiety Inventory | Self-report measure of anxiety symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome. | 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 |
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Inclusion Criteria:
- Moderate or major depressive episode as primary diagnosis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Reidar Stiegler, PhD | Institute for Psychological Counselling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institutt for Psykologisk rådgivning | Bergen | Bergen | 5012 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20063907 | Background | Dimidjian S, Hollon SD. How would we know if psychotherapy were harmful? Am Psychol. 2010 Jan;65(1):21-33. doi: 10.1037/a0017299. | |
| 19583884 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2021 | Feb 12, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000071441 | Emotion-Focused Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized Clinical Trial
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| Emotion-Focused Therapy | Behavioral | 14-18 sessions of EFT |
|
|
Self-report measure of symptoms related to eating disorders, average scores, minimum 0, maximum 6, higher score indicates worse outcome. |
| 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 | Self-report measure of interpersonal difficulties, average scores minimum 0, maximum 4. Higher score suggests worse outcome. | 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 | Self-report measure of psychological flexibility, average scores minimum 1, maximum 7. Higher score 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 |
| Change in Emotion Approach Coping Scale | Self-report measure of emotional processing ability, average scores minimum 1, maximum 4. Higher score suggests better outcome. | 1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up |
| Change in Penn State Worry Questionaire | Self-report measure of rumination and cognitive processing, total scores minimum 16, maximum 80. Higher score suggests worse outcome. | 1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up |
| Change in Self-Compassion Scale | Self-report measure of self-relating, average scores, minimum 1, maximum 5, higher scores suggests better outcome. | 1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up |
| Change in Quality of life questionnaire | Self-report measure of quality of life, average scores, minimum 1, maximum 5, higher scores indicate better outcome. | 1 week before treatment startup, within 1 week after treatment, 3 month follow up, 6 month follow up, 12 months follow up |
| Change in Working Alliance Inventory - short version | Self report measure on experience of therapeutic alliance, average scores, minimum 1, maximum 7, higher scores suggests better outcome. | 1 day after 1st through 14th therapy session. |
| 20099202 | Background | Elliott R. Psychotherapy change process research: realizing the promise. Psychother Res. 2010 Mar;20(2):123-35. doi: 10.1080/10503300903470743. |
| Background | 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. |
| 12924682 | 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. |
| Background | 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. |
| 19034715 | Background | Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899. |
| 22082384 | Background | Kazdin AE. Evidence-based treatment research: Advances, limitations, and next steps. Am Psychol. 2011 Nov;66(8):685-698. doi: 10.1037/a0024975. |
| 12642531 | Background | 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. |
| Background | 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 |
| 29466928 | 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. |
| 41031587 | Derived | 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. |