DepressionNCT04690946
Comparing Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
A study testing Cognitive Behavioral Therapy and Emotion-Focused Therapy in people with Depression, run by Institutt for Psykologisk Radgivning at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavioral Therapy and Emotion-Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNorway
- Study dates
- 20 Jan 2021to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate or major depressive episode as primary diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study Comparing the Therapeutic Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
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.
Read the 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:
- EFT and CBT will not result in significantly different outcome in the treatment of patients with moderate and major depressive disorder.
- 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.
- 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?
- What do patients in both conditions describe as helpful and unhelpful aspects of treatment?
- How do patients in both conditions describe their own change or lack or change after treatment?
- How do patients that choose to drop out of treatment describe the processes leading to that decision?
- Conditions
- Depression
- Being tested
- Cognitive Behavioral Therapy, Emotion-Focused Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
14-18 sessions of CBT
Emotion-Focused TherapyBehavioural
Also called EFT
14-18 sessions of EFT
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | 14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Emotion-Focused Therapy | Active comparator | 14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy Receives: Behavioral: Emotion-Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Self-report measure of anxiety symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.
Measured: 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
Self-report measure of symptoms related to eating disorders, average scores, minimum 0, maximum 6, higher score indicates worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day after 1st through 14th therapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start20 Jan 2021
- Primary completion30 Jul 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutt for Psykologisk Radgivning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Jan Reidar Stiegler, PhD, Principal investigator, Institute for Psychological Counselling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690946
- Sponsor's protocol ID
- IPR
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dimidjian S, Hollon SD. How would we know if psychotherapy were harmful? Am Psychol. 2010 Jan;65(1):21-33. doi: 10.1037/a0017299.
PubMed 20063907Blatt 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.
PubMed 19583884Elliott R. Psychotherapy change process research: realizing the promise. Psychother Res. 2010 Mar;20(2):123-35. doi: 10.1080/10503300903470743.
PubMed 20099202Goldman, 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.
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.
PubMed 12924682Greenberg, 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 AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
PubMed 19034715Kazdin AE. Evidence-based treatment research: Advances, limitations, and next steps. Am Psychol. 2011 Nov;66(8):685-698. doi: 10.1037/a0024975.
PubMed 22082384Kendall 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.
PubMed 12642531Lambert, 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.
What have we learned about treatment failure in empirically supported treatments
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. N., & Greenberg, L. S. (Eds.). (1984). Patterns of change: Intensive analysis of psychotherapy process. Guilford Press.
Roth, A & Fonagy, P (1996) What works for whom? New York: Guilford Press
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing the Therapeutic Effect and Change Processes in Cognitive Behavioral Therapy and Emotion-Focused Therapy for Depression
- ClinicalTrials.gov ID
- NCT04690946
- Acronym / sponsor ID
- IPR
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Institutt for Psykologisk RadgivningUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- EFT and CBT will not result in significantly different outcome in the treatment of patients with moderate and major depressive disorder.
- 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.
- 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?
- What do patients in both conditions describe as helpful and unhelpful aspects of treatment?
- How do patients in both conditions describe their own change or lack or change after treatment?
- How do patients that choose to drop out of treatment describe the processes leading to that decision?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral Therapy14-18 sessions of psychotherapy according to principles of Cognitive Behavioral Therapy |
| Emotion-Focused Therapy | Active comparator | Behavioral: Emotion-Focused Therapy14-18 sessions of psychotherapy according to principles of Emotion Focused Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate or major depressive episode as primary diagnosis
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT14-18 sessions of CBT | Behavioural | Cognitive Behavioral Therapy |
| Emotion-Focused TherapyAlso: EFT14-18 sessions of EFT | Behavioural | Emotion-Focused Therapy |
Primary outcome
Change in Beck Depression Inventory from session to session
Time frame: 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
Self-report measure of depressive symptoms, ranging from minimum 0 and maximum 63. Higher scores suggests worse outcome.
9 secondary outcomes
Change in Beck Anxiety Inventory
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 day after 1st through 14th therapy session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 20063907Dimidjian S, Hollon SD. How would we know if psychotherapy were harmful? Am Psychol. 2010 Jan;65(1):21-33. doi: 10.1037/a0017299.
- Background: PubMed 19583884Blatt 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.
- Background: PubMed 20099202Elliott R. Psychotherapy change process research: realizing the promise. Psychother Res. 2010 Mar;20(2):123-35. doi: 10.1080/10503300903470743.
- BackgroundGoldman, 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: PubMed 12924682Watson 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.
- BackgroundGreenberg, 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: PubMed 19034715Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
- Background: PubMed 22082384Kazdin AE. Evidence-based treatment research: Advances, limitations, and next steps. Am Psychol. 2011 Nov;66(8):685-698. doi: 10.1037/a0024975.
- Background: PubMed 12642531Kendall 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.
- BackgroundLambert, 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.
- BackgroundWhat have we learned about treatment failure in empirically supported treatments
- BackgroundNICE (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
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Reidar Stiegler, PhD principal investigator
Institute for Psychological Counselling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Emotion-Focused Therapy in people with Depression, run by Institutt for Psykologisk Radgivning at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Depression Inventory from session to session (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690946, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.