Mental HealthCROPNCT05630560
Common Factors, Responsiveness and Outcome in Psychotherapy
An observational study of Mental Health and Psychological Distress, run by The Common Factors, Responsiveness and Outcome of Psychotherapy Study at 1 site in Denmark.
Trial summary
The "Common Factors, Responsiveness and Outcome of Psychotherapy" (CROP) study is a naturalistic observational study at the University of Copenhagen (UCPH) carried out in cooperation with psychologists in the Danish practice sector or in private practice. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Psychological Distress, General Psychotherapy
- What is being tested?
- Psychotherapy treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2019to 1 Jul 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All clients in individual psychotherapy aged 18 or older are eligible for the study, meaning that in principle all client diagnoses and referral reasons may be represented in the sample. However, in Denmark, reimbursement for psychological treatment in the practice sector is only provided for clients referred by their general practitioner for one of the 11 referral reasons and diagnoses presented below. Thus, clients meeting these characteristics are likely to be overrepresented within the sample.
Who may be able to join
- Above 18 of age and in individual psychotherapy
Who cannot join
- severe psychoticism or other severe mental health issues.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen
Copenhagen, 1353
Stig Poulsen, Professor, +45 28 59 35 43, stig.poulsen@psy.ku.dk
Rikke Agner, Coordinator, + 45 35 32 48 88, rikke.agner@psy.ku.dk
About this study
Official title: Common Factors, Responsiveness and Outcome in Psychotherapy (CROP): Study Protocol for an Observational Study of Psychotherapy in Private Practice
The "Common Factors, Responsiveness and Outcome of Psychotherapy" (CROP) study is a naturalistic observational study at the University of Copenhagen (UCPH) carried out in cooperation with psychologists in the Danish practice sector or in private practice. The study aims to examine the contribution of client, therapist and treatment characteristics, as well as the role of therapists' responsiveness, on the process and outcome of psychotherapy. Participating psychologists and clients fill out background questionnaires prior to initiating therapy, and process data for each course of treatment is collected weekly and after each session while outcome data is collected at end of treatment and at three months follow-up. The psychologists are reimbursed DKK 1,000 per client that contributes to the study with at least three session questionnaires, which corresponds to the hourly salary of a psychologist in Danish private practice. All data is collected through an automated, online database to ensure appropriate anonymization and data management, and all participants give informed consent prior to participation. The CROP study has been approved by the UCPH's Department of Psychology's ethical review board and the Danish Data Protection Agency.
Read the detailed description
The aim of the Common factors, Responsiveness and Outcome in Psychotherapy study (CROP) is to determine client and psychologist characteristics and therapeutic processes associated with the outcome of psychotherapy delivered by psychologists in the Danish practice sector or in private practice. The study addresses two main questions. First, how are specific characteristics of clients and psychologists related to the outcome of therapy and do these characteristics moderate the outcome of different psychotherapeutic approaches? Second, to what extent do therapists adapt their approach to client characteristics and preferences and how does such responsiveness impact the process and outcome of therapy? The results from the study are directly relevant to psychologists and will be disseminated nationwide during and after the end of the study.
The study is a naturalistic, observational study carried out in collaboration with psychologists in the Danish practice sector or in private practice. Self-report data is collected on the participating psychologists and their participating clients before psychotherapy, during psychotherapy (weekly and post-session) and after psychotherapy (at end of treatment and three months follow-up). The data is analyzed using multilevel modeling and structural equation modeling approaches.
The study design and data management procedure have been approved by the Research Ethics Board of the Department of Psychology, University of Copenhagen, and the Danish Data Protection Agency. All data are fully anonymized and stored in agreement with the Danish Act on Processing of Personal Data. All parts of the study are based on the principles of informed consent and clients are informed that they can terminate their participation in the study at any time without consequences to their treatment. The findings of the study will be presented in articles in international, peer-reviewed journals as well as to psychotherapy practitioners across Denmark.
- Conditions
- Mental Health, Psychological Distress, General Psychotherapy
- Being tested
- Psychotherapy treatment
- Keywords
- psychotherapy research, psychotherapy effect, psychotherapy process and outcome, therapist effects, therapy predictors and moderators, therapist responsiveness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy treatmentOther
The psychotherapist will conduct psychotherapy as normally done by them in their practice. The treatment will thus be un-manualized and consist of a broad range of therapeutic orientations and treatment lengths.
| Study group | Role | What they receive |
|---|---|---|
| Psychologists in Danish private practice | All psychologists with a Danish university degree in psychology who have registered themselves as seeing clients in private practice (app. 1,750) have been invited to participate in the study. Thus, the sample of psychologists consists of psychologists employed in the Danish practice sector, where clients obtain a refund of 60% of the psychologist's salary, as well as psychologists working privately without any reimbursement of their salaries. Each psychologist enrolled in the study has agreed to aim to recruit no less than 10 clients each for the study. We aim to include 100 psychologists, which will yield a sample of 1,000 clients beginning therapy. Receives: Other: Psychotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological symptoms measured by the BSI
The Brief Symptom Inventory (BSI) is a self-report scale consisting of 53 items covering nine symptom dimensions: Somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.
Measured: Change in psychological symptoms from baseline until end-of-treatment (an average of 7 months).
Secondary outcomes (1)
Change in symptoms measured by the Symptom Checklist-11
Symptom Checklist-11 (SCL-11) is a short, multidimensional outcome measure for the evaluation of therapeutic progress in psychotherapy, consisting of 11 items selected from the BSI using a stepwise item selection procedure
Measured: Every week while the client is in therapy, up until 25 weeks of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jan 2019
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Common Factors, Responsiveness and Outcome of Psychotherapy Study
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, The Health Foundation, TRYG Foundation, the Danish Psychological Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630560
- Sponsor's protocol ID
- 16-B-0269
- Acronym
- CROP
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data is planned to be shared with other researchers besides the CROP research team members.
Publications
Igra L, Mayo O, Kivity Y, Jacobsen CF, Lunn S, Poulsen S. Early alliance growth and changes in attachment styles in psychotherapy. Psychotherapy (Chic). 2026 Jun 8. doi: 10.1037/pst0000622. Online ahead of print.
PubMed 42258283Jacobsen CF, Igra L, Lunn S, Karstoft KI, Nielsen J, Lauritzen L, Falkenstrom F, Poulsen S. The association between therapist internal relational models, professional self-doubt, and coping strategies and the process and outcome of psychotherapy. Psychother Res. 2026 Mar;36(3):484-499. doi: 10.1080/10503307.2025.2506650. Epub 2025 May 27.
PubMed 40424535Jacobsen CF, Falkenstrom F, Karstoft KI, Igra L, Lunn S, Nielsen J, Lauritzen L, Poulsen S. Exploring the matching effect: The association between preference accommodation, the working alliance, and outcome in psychotherapy. J Consult Clin Psychol. 2025 Jun;93(6):443-456. doi: 10.1037/ccp0000955.
PubMed 40388150Jacobsen CF, Falkenstrom F, Castonguay L, Nielsen J, Lunn S, Lauritzen L, Poulsen S. The relationship between attachment needs, earned secure therapeutic attachment and outcome in adult psychotherapy. J Consult Clin Psychol. 2024 Jul;92(7):410-421. doi: 10.1037/ccp0000900.
PubMed 39190445Faye Jacobsen C, Karstoft KI, Falkenstrom F, Nielsen J, Lunn S, Poulsen S. Client preferences, therapy activities and preference-activity match as predictors of therapy outcome. Psychother Res. 2025 Jun;35(5):777-792. doi: 10.1080/10503307.2024.2353358. Epub 2024 May 21.
PubMed 38771973Lauritzen LR, Faye Jacobsen C, Nielsen J, Lunn S, Mathiesen BB, Falkenstrom F, Poulsen S. Common factors, Responsiveness and Outcome in Psychotherapy (CROP): study protocol for a naturalistic prospective cohort study of psychotherapy in Denmark. BMJ Open. 2023 Jun 2;13(6):e072277. doi: 10.1136/bmjopen-2023-072277.
PubMed 37270190
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Factors, Responsiveness and Outcome in Psychotherapy (CROP): Study Protocol for an Observational Study of Psychotherapy in Private Practice
- ClinicalTrials.gov ID
- NCT05630560
- Acronym / sponsor ID
- CROP / 16-B-0269
- Conditions
- Mental Health, Psychological Distress, General Psychotherapy
- Keywords
- psychotherapy research, psychotherapy effect, psychotherapy process and outcome, therapist effects, therapy predictors and moderators, therapist responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Common Factors, Responsiveness and Outcome of Psychotherapy StudyUniversity, hospital or other
- Collaborators
- University of Copenhagen, The Health Foundation, TRYG Foundation, the Danish Psychological Association
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 29 Nov 2022 (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.
The "Common Factors, Responsiveness and Outcome of Psychotherapy" (CROP) study is a naturalistic observational study at the University of Copenhagen (UCPH) carried out in cooperation with psychologists in the Danish practice sector or in private practice. The study aims to examine the contribution of client, therapist and treatment characteristics, as well as the role of therapists' responsiveness, on the process and outcome of psychotherapy. Participating psychologists and clients fill out background questionnaires prior to initiating therapy, and process data for each course of treatment is collected weekly and after each session while outcome data is collected at end of treatment and at three months follow-up. The psychologists are reimbursed DKK 1,000 per client that contributes to the study with at least three session questionnaires, which corresponds to the hourly salary of a psychologist in Danish private practice. All data is collected through an automated, online database to ensure appropriate anonymization and data management, and all participants give informed consent prior to participation. The CROP study has been approved by the UCPH's Department of Psychology's ethical review board and the Danish Data Protection Agency.
Detailed description
The aim of the Common factors, Responsiveness and Outcome in Psychotherapy study (CROP) is to determine client and psychologist characteristics and therapeutic processes associated with the outcome of psychotherapy delivered by psychologists in the Danish practice sector or in private practice. The study addresses two main questions. First, how are specific characteristics of clients and psychologists related to the outcome of therapy and do these characteristics moderate the outcome of different psychotherapeutic approaches? Second, to what extent do therapists adapt their approach to client characteristics and preferences and how does such responsiveness impact the process and outcome of therapy? The results from the study are directly relevant to psychologists and will be disseminated nationwide during and after the end of the study.
The study is a naturalistic, observational study carried out in collaboration with psychologists in the Danish practice sector or in private practice. Self-report data is collected on the participating psychologists and their participating clients before psychotherapy, during psychotherapy (weekly and post-session) and after psychotherapy (at end of treatment and three months follow-up). The data is analyzed using multilevel modeling and structural equation modeling approaches.
The study design and data management procedure have been approved by the Research Ethics Board of the Department of Psychology, University of Copenhagen, and the Danish Data Protection Agency. All data are fully anonymized and stored in agreement with the Danish Act on Processing of Personal Data. All parts of the study are based on the principles of informed consent and clients are informed that they can terminate their participation in the study at any time without consequences to their treatment. The findings of the study will be presented in articles in international, peer-reviewed journals as well as to psychotherapy practitioners across Denmark.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychologists in Danish private practice | – | Other: Psychotherapy treatmentAll psychologists with a Danish university degree in psychology who have registered themselves as seeing clients in private practice (app. 1,750) have been invited to participate in the study. Thus, the sample of psychologists consists of psychologists employed in the Danish practice sector, where clients obtain a refund of 60% of the psychologist's salary, as well as psychologists working privately without any reimbursement of their salaries. Each psychologist enrolled in the study has agreed to aim to recruit no less than 10 clients each for the study. We aim to include 100 psychologists, which will yield a sample of 1,000 clients beginning therapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All clients in individual psychotherapy aged 18 or older are eligible for the study, meaning that in principle all client diagnoses and referral reasons may be represented in the sample. However, in Denmark, reimbursement for psychological treatment in the practice sector is only provided for clients referred by their general practitioner for one of the 11 referral reasons and diagnoses presented below. Thus, clients meeting these characteristics are likely to be overrepresented within the sample.
Key inclusion criteria (1 listed)
- Above 18 of age and in individual psychotherapy
Key exclusion criteria (1 listed)
- severe psychoticism or other severe mental health issues.
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 |
|---|---|---|
| Psychotherapy treatmentThe psychotherapist will conduct psychotherapy as normally done by them in their practice. The treatment will thus be un-manualized and consist of a broad range of therapeutic orientations and treatment lengths. | Other | Psychologists in Danish private practice |
Primary outcome
Change in psychological symptoms measured by the BSI
Time frame: Change in psychological symptoms from baseline until end-of-treatment (an average of 7 months).
The Brief Symptom Inventory (BSI) is a self-report scale consisting of 53 items covering nine symptom dimensions: Somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.
1 secondary outcome
Change in symptoms measured by the Symptom Checklist-11
Time frame: Every week while the client is in therapy, up until 25 weeks of therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 42258283Igra L, Mayo O, Kivity Y, Jacobsen CF, Lunn S, Poulsen S. Early alliance growth and changes in attachment styles in psychotherapy. Psychotherapy (Chic). 2026 Jun 8. doi: 10.1037/pst0000622. Online ahead of print.
- Derived from this study: PubMed 40424535Jacobsen CF, Igra L, Lunn S, Karstoft KI, Nielsen J, Lauritzen L, Falkenstrom F, Poulsen S. The association between therapist internal relational models, professional self-doubt, and coping strategies and the process and outcome of psychotherapy. Psychother Res. 2026 Mar;36(3):484-499. doi: 10.1080/10503307.2025.2506650. Epub 2025 May 27.
- Derived from this study: PubMed 40388150Jacobsen CF, Falkenstrom F, Karstoft KI, Igra L, Lunn S, Nielsen J, Lauritzen L, Poulsen S. Exploring the matching effect: The association between preference accommodation, the working alliance, and outcome in psychotherapy. J Consult Clin Psychol. 2025 Jun;93(6):443-456. doi: 10.1037/ccp0000955.
- Derived from this study: PubMed 39190445Jacobsen CF, Falkenstrom F, Castonguay L, Nielsen J, Lunn S, Lauritzen L, Poulsen S. The relationship between attachment needs, earned secure therapeutic attachment and outcome in adult psychotherapy. J Consult Clin Psychol. 2024 Jul;92(7):410-421. doi: 10.1037/ccp0000900.
- Derived from this study: PubMed 38771973Faye Jacobsen C, Karstoft KI, Falkenstrom F, Nielsen J, Lunn S, Poulsen S. Client preferences, therapy activities and preference-activity match as predictors of therapy outcome. Psychother Res. 2025 Jun;35(5):777-792. doi: 10.1080/10503307.2024.2353358. Epub 2024 May 21.
- Derived from this study: PubMed 37270190Lauritzen LR, Faye Jacobsen C, Nielsen J, Lunn S, Mathiesen BB, Falkenstrom F, Poulsen S. Common factors, Responsiveness and Outcome in Psychotherapy (CROP): study protocol for a naturalistic prospective cohort study of psychotherapy in Denmark. BMJ Open. 2023 Jun 2;13(6):e072277. doi: 10.1136/bmjopen-2023-072277.
- Individual participant dataSharing planned: No. No participant data is planned to be shared with other researchers besides the CROP research team members.
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Psychological Distress, run by The Common Factors, Responsiveness and Outcome of Psychotherapy Study at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stig Poulsen, Professor (+45 28 59 35 43, stig.poulsen@psy.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological symptoms measured by the BSI (time frame: Change in psychological symptoms from baseline until end-of-treatment (an average of 7 months).). 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 NCT05630560, which also lists 6 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 29 Nov 2022.