Randomized Controlled Study Comparing the Therapeutic Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
Phase: NA
Conditions: Depression
Sponsor: Institutt for Psykologisk Radgivning

TITLE PAGE 
 
Official Title of the study: 
Randomized controlled trial comparing the therapeutic effect and change 
processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for 
depression. 
NCT number: N/A 
Date of document: 09.02.21 
 
 

 
Randomized controlled trial comparing the therapeutic effect and change 
processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for 
depression.  
A collaboration between the Norwegian Institute of Emotion Focused Therapy (NIEFT), Institute for 
Psychological counselling (IPR) and Department of Clinical Psychology, University of Bergen).  
  
Director of Research/ chair of the project committee: Dr. Jan Reidar Stiegler (Academic Director, NIEFT).  
Researchers:  Hanna Aardal (PhD candidate) Yngvild Danielsen (associate professor, UiB), Aslak Hjeltnes 
(associate professor, UiB), Elisabeth Schanche (associate professor, UiB), Dr. Jan Reidar Stiegler (Academic 
Director, NIEFT).  
Project period: 1.1.2021 – 12.31.2030  
  
Introduction and background  
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 (National Institute for Health and Care excellence, 2009). However, research indicates 
that not all patients respond to CBT (Lambert, 2011), indicating a need to expand the range of 
available evidence-based psychotherapies, and mapping the mechanisms of change in existing 
treatments (Dimidjian & Hollon, 2010; Kazdin, 2009).   
Emotion focused therapy (EFT) is one promising treatment for depression with empirical support for 
its efficacy (Elliot et al. 1990; Goldman, Greenberg & Angus, 2006; Greenberg & Watson, 1998; 
Watson et al. 2003). A previous study found equal outcome in CBT and Process-Experiential 
treatment/EFT for depression (Watson et al; 2003), 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 (Lambert, 2011). There is a need for 
research that investigates what treatments works for whom, based on patient characteristics and 
preferences (Blatt, 2008; Nilsson et al., 2007; Roth & Fonagy, 1996). 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 (Kazdin, 2011). 
Processoutcome studies are commonly used for this purpose (Rice & Greenberg, 1984; Watson, 
2018). 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 (Kendall, 2018). 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, emotional coping, rumination/worry, 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?   
  
Enrollment  
A) Number of participants   
B) Source of recruitment  
C) Description of participants   

N = 112 (56 in each condition).   
  
If the publicly funded program 
“Return to work” is continued 
within the organization 
Institutt for Psykologisk 
rådgivning in 2022, and the 
local ethics committee (REK) 
approves, the number of 
participants will be increased in 
order to increase the statistical 
power of the study.   
  
Based on previous studies  
(Watson et al, 2003; Stiegler, 
Molde & Schanche, 2017), 
estimated sample size is 
sufficient to investigate 
significant differences between 
conditions .   
An effect size (Cohen's d) on 
the primary outcome measure 
is approximately 0.50 
(moderate). Power analysis 
show that there is a 32 % 
probability of detecting 
significant results given that 
there is an actual large 
difference between the 
conditions. The calculations  
The government funded mental 
health program «Return to 
work».   
  
Based on the current number 
of referrals to this program, we 
expect to recruit at least 112 
participants during the 
recruitment phase. If, for 
unknown reasons, we are 
faced with difficulties in the 
recruitment of participants, the 
backup solution will be to 
supply participants from the 
ordinary intake of self-referred 
patients to Institutt for  
Psykologisk rådgivning.   
Adults 18 years and older with 
symptoms of moderate or 
major depression referred by 
their general practitioner for 
participation in the program 
“Return to work”.  
  
are taken from Howell (2013). 
An estimated drop out rate of 
20 % implies that we will need  
to recruit 112 patients for this 
study. Fifty-six randomized to 
the EFT condition and fifty-six 
to the CBT condition. We will 
use both frequentist and 
Bayesian to analyze the data. 
We will use Linear Mixed 
Models to estimate the effect 
of the interventions, and 
structural equation modelling 
to analyze moderating and 
mediating factors. As we expect 
that there will be no significant 
difference between the 
conditions, we will utilize 
Bayesian statistical procedures 
to get a more nuanced picture 
 
 

of the data, which might help 
us to draw some more 
conclusions out of the data.  
  
Patients eligible for the program who based on the referral from their general practitioner present 
with depression as an issue will be contacted by phone and given verbal information about the study. 
Patients who are interested in participating, will also receive written information, and will be given 
one week to consider participating. For patients who consent to be evaluated for participation, a 
meeting will be scheduled to evaluate their eligibility for the study. Screening will be conducted by 
members of the research team who are not participating as therapist in the project.   
  
Screening/selection of participants  
A) Pre-screening  
B) Clinical screening   
C) Criteria for participation   
By phone:   
  
Inclusion:  
1) Eligible for the Return to 
work program based on 
referral from GP.  
2) Symptoms of depression as 
described in the referral.   
3) Interest in participating in 
the study.  
  
Exclusion:  
1) Not interested in taking part 
in the research study.   
- 
Mini – International 
neuropsychiatric interview 
(M.I.N.I., version 6.0.0). - 
Structured Clinical Interview 
for DSM-IV (SCID-II).  
- 
Hamilton  
  
1) INCLUSION:  
i) Moderate or major 
depressive episode as primary 
diagnosis  
  
2) EXCLUSION  
i) 
Serious mental illness 
(schizophrenia, severe bipolar 
disorder, recent or current 
psychotic episode) or 
intellectual disability.   
ii) 
Severe alcohol or drug 
abuse, last 12 months.  iii) 
Suicidality last 6 months iv) 
Severe medical issues v) 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.  vi) The 
participant is currently in 
another treatment for 
depression   
 
 
vii) Severe Borderline or 
narcissistic personality  
disorder  
  
  
  
Patients not eligible for the study will be referred back to standard treatment within the Return to 
Work program. Patients included in the study will be randomly allocated to one of the two treatment 

conditions. An independent researcher will carry out the randomization procedure. In both 
conditions, the patients will receive 14-18 session of individual therapy, the same number of sessions 
as standard treatment in the program.   
  
Patients are blinded to the study conditions. No information about study design or the type of 
intervention is given to the patients, except that they will be told that both treatments focus on 
learning to cope with negative thoughts and feelings.   
  
Rando mization  
EFT  
CBT  
14-18 sessions individual therapy  
EFT intervention  
N=56   
  
14-18 sessions individual therapy  
CBT intervention   
N=56  
  
  
  
Pre-treatment self-report measures  
Primary symptoms:  
1. 
Beck Depression Inventory, BDI-II Secondary symptoms:  
2. 
Beck Anxiety Inventory, BAI  
3. 
Repetitive Eating Questionnaire, REP(EAT)-Q 
Interpersonal functioning:  
4. 
Inventory of Interpersonal problems, IIP Cognitive and 
emotional and cognitive functioning:  
5. 
The Acceptance and Action Questionnaire, AAQ-2 
6. 
Emotion Approach Coping Scale 
7. 
Penn State Worry Questionaire 
 Relationship to self:  
8. 
Self-Compassion Scale, SCS Other measures:  
9. 
Adverse Childhood experiences, ACEs   
10. 
Quality of life questionnaire  
  
  
  
Mid-, post-treatment and follow up (3, 6 and 12 months)  
A) Self report measures   
B) Post-treatment qualitative interviews  
Measures of primary symptoms:  
Primary symptoms:  
1. Beck Depression Inventory, BDI-II Secondary 
symptoms:  
2. Beck Anxiety Inventory, BAI  
3. Repetitive Eating Questionnaire, REP(EAT)-Q  
15 participants from each condition (N=30).  
  
Up to 12 participants who drop out of 
treatment will be selected to undergo a 
qualitative interview.  

Interpersonal functioning:  
4. Inventory of Interpersonal problems, IIP  
Cognitive and emotional functioning:  
5. The Acceptance and Action  
Questionnaire, AAQ-2  
emotional and cognitive 
functioning:  
11. 
The 
Acceptance and Action 
Questionnaire, AAQ-2 
12. 
Emotion 
Approach Coping Scale 
13. 
Penn 
State Worry 
Questionaire 
 
Relationship to self:  
6. Self-Compassion Scale, SCS Other measures:  
7. Quality of life questionnaire  
  
 
  
Process measure for each session  
Self-report measures:   
1. Beck Depression Inventory, BDI-II  
2. Working Alliance Inventory - short version, WAI  
3. The Acceptance and Action Questionnaire, AAQ-2  
  
Video-observed process measures:   
1. Measure of Expressed Empathy (MEE), Watson, 1999.  
2. The Experiencing Scale, Klein et al., 1969.  
3. Classification of Affective-Meaning States (CAMS)  
  
  
To study changes in psychotherapeutic processes we need access to the patient’s verbal and 
nonverbal expression. All therapy sessions will be video-recorded. Observation and rating of video 
recorded therapy sessions are the most reliable method to control for therapist adherence to the 
method.   
  
Competence and adherence measures  
EFT  
CBT  
1. Working alliance Inventory, WAI  2. 
Person-Centered & Experiential  
Psychotherapy Scale—EFT supplement  
  
1. Working alliance Inventory, WAI  
2. Cognitive Therapy Adherence and  
Competence Scale   
  
  
 

References   
Blatt, S. J. (2008). Polarities of experience: Relatedness and self-definition in personality development, 
psychopathology, and the therapeutic process. Washington DC: American Psychological Association.    
  
Dimidjian, S., & Hollon, S. D. (2010). How would we know if psychotherapy were harmful? American 
Psychologist, 65(1), 21-33.   
  
Elliott, Robert (2010) Psychotherapy change process research: Realizing the promise, Psychotherapy 
Research, 20:2, 123-135.   
  
Goldman, R; Greenberg, L. & Angus, L. (2006). The effects of adding emotion-focused interventions to 
the client-centered relationship conditions in the treatment of depression. Psychoterapy Research. 
Vol. 16.  
  
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.   
  
Kazdin, Alan (2009) Understanding how and why psychotherapy leads to change, Psychotherapy 
Research, 19:4-5, 418-428.   
  
Kazdin, A. E. (2011). Evidence-based treatment research: Advances, limitations, and next steps. 
American Psychologist, 66(8), 685.  
  
Kendall, J. M. (2018). Designing a research project: randomized controlled trials and their principles. 
Med. Journal, V. 20, 164-168.  
  
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.  
  
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  
  
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.  
  
Rice, L & Greenberg, L (1984) Intensive Analysis of Psychotherapy Process. New York: Guilford Press  
  
Roth, A & Fonagy, P (1996) What works for whom? New York: Guilford Press  
  
Watson, J. C., Gordon, L. B., Stermac, L., Kalogerakos, F., & Steckley, P. (2003). Comparing the 
effectiveness of process-experiential with cognitive-behavioral psychotherapy in the treatment of 
depression. Journal of Consulting and Clinical Psychology, 71(4), 773-781.    
  
Watson, J. C. (2018). Mapping patterns of change in emotion-focused psychotherapy: Implications for 
theory, research, practice, and training. Psychotherapy Research, 28(3), 389-405.