Psychological DisorderCAMPNCT03503981
Examining Change Mechanisms in Psychotherapy
An observational study of Psychological Disorder and Anxiety Disorders, run by Modum Bad at 1 site in Norway.
Trial summary
This research project seeks to acquire a deeper understanding of the complex influences of common factors and specific ingredients in psychotherapy. By using frequent process-outcome measures, it will address individualized mechanisms of change in psychotherapy by assessing both between and within patient change… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Disorder, Anxiety Disorders, Depression
- What is being tested?
- Psychotherapy
- How many people
- 520 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2017to 20 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients accepted for inpatient treatment at Modum Bad Psychiatric hospital during the time of data collection will participate in this study, contingent on consent. The patients included will be all genders, adults and reciving treatment from specialist health care.
Who may be able to join
- Must be a patient at Modum Bad
- Have a psychological disorder
- Must have rights to treatment according to the rules of specialist health care in Norway. Includes the following:
- Patient is expected to have poorer prognosis of life quality if not given treatment
- It is expected that the patient will benefit from treatment
- It is expected that there is a reasonable cost-effect balance regarding the treatment given and the patient's benefit from treatment.
Who cannot join
- Acute suicidality
- Ongoing/active abuse of harmful drug(s)
- Under 18 years
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Modum Bad
Vikersund, Buskerud, 3370
Terje Tilden, PhD, 32749869 ext. 0047, tilden@modum-bad.no
Ingvild Finsrud, Master
About this study
Official title: Examining Change Mechanisms in Psychotherapy: Relationship Between Specific Ingredients and Common Factors in Promoting Change.
This research project seeks to acquire a deeper understanding of the complex influences of common factors and specific ingredients in psychotherapy. By using frequent process-outcome measures, it will address individualized mechanisms of change in psychotherapy by assessing both between and within patient change processes, using a wide spectrum of change indicators.
Read the detailed description
The study is a naturalistic study conducted by collecting data from in-patient units at Modum Bad (psychiatric hospital). The sample includes different patient groups with a variety of psychological disorders. Further, sample is gathered from units using different treatment approaches (short-term psychodynamic treatment, cognitive-behavioral treatment, metacognitive therapy, compassion-focused therapy, relational psychodynamic therapy, existential therapy and stabilizing trauma-therapy).
The following specific research questions will be explored:
- The role of common factors:
- What are the relative influences of different common factors such as agreement on task and goals, treatment credibility and 'the real relationship', across treatments and diagnoses?
- Do some common factor variables stand out regarding ability to explain variance in outcome and across outcomes?
- Do measures of common factors have a consistent effect on outcome across treatment models and diagnoses, or does the explanatory value of common factors vary across diagnose and treatment model?
- The role of specific change mechanisms (affective, cognitive and meta-cognitive):
- To what extent do specific change mechanisms predict change in various outcome domains?
- Are these specific change mechanisms equally important predictors, or do they vary across treatment or diagnose?
- Are there interaction effects between common factors and specific factors across treatment models, patient diagnoses and outcome domain?
Self-report data will be collected three times a week on mechanisms of change and symptoms, established by psychotherapy theory and research evidence as important for psychological change. The data collection consists of three different forms administered once per week on different days. The forms are separated by topic; symptoms, contextual factors, and change processes. The questions in the forms are selected from short instruments with good psychometric qualities. The data collection procedure has at present been tested on five patient cohorts with good results.
- Conditions
- Psychological Disorder, Anxiety Disorders, Depression, Eating Disorder, Post Traumatic Stress Disorder
- Being tested
- Psychotherapy
- Keywords
- Process-outcome study, Mechanisms of change
- Medical subject headings
- Mental Disorders, Anxiety Disorders, Depression, Feeding and Eating Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.
| Study group | Role | What they receive |
|---|---|---|
| Anxiety unit | Patients have anxiety as a primary diagnose. Receive treatment for anxiety (CBT and MCT). Receives: Other: Psychotherapy | |
| Eating disorder unit | Patients have eating disorder as primary diagnose. Receive treatment for their eating disorder (CBT and compassion-focused therapy). Receives: Other: Psychotherapy | |
| Depression unit | Patients have depression as primary disorder. Receive treatment for their depression (Short-term dynamic therapy, existential therapy and relational psychodynamic therapy). Receives: Other: Psychotherapy | |
| Family unit | One of the members of the family has a psychological disorder. The treatment is focused towards the family and family dynamics. Receives: Other: Psychotherapy | |
| Trauma unit | Patients have PTSD and relational trauma as primary diagnosis. Receive stabilizing treatment and exposure therapy. Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom checklist revised (SCL-90-R)
A general measure of symptoms distress
Measured: Change measure (baseline, 14 weeks, and 12 months).
Secondary outcomes (8)
Inventory of interpersonal problems
Self-report questionnaire of interpersonal problems
Measured: Change measure (baseline, 14 weeks, and 12 months).
Beck's depression inventory
Measure of depressive symptoms
Measured: Change measure (baseline, 14 weeks, and 12 months).
PTSD checklist for Diagnostic and Statistical Manual 5 (PCL-5)
PTSD symptom measure
Measured: Change measure (baseline, 14 weeks, and 12 months).
M-POQ outcome, anxiety
Measures anxiety symptoms
Measured: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, depression
Measures depression symptoms
Measured: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, loneliness
Measures experienced loneliness
Measured: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, resilience
Measures experienced recilience
Measured: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, well-being
Measures experienced well-being
Measured: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start15 Sep 2017
- Primary completion20 Aug 2020 (estimated)
- Study completion20 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychological DisorderStudies 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
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503981
- Sponsor's protocol ID
- CAMPFinsrud
- Acronym
- CAMP
- Status last verified
- Apr 2018
- First submitted
- 25 Jan 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johansen FT, Finsrud I, Flo-Groeneboom E, Kvamme IR. Transformative pathways: shame and fear of compassion as potential mechanisms of change in psychotherapy. Psychother Res. 2026 Sep 23:1-13. doi: 10.1080/10503307.2026.2732028. Online ahead of print.
PubMed 42775480Finsrud I, Nissen-Lie HA, Ulvenes P, Melsom L, Vrabel K, Wampold B. Confidence in the therapist and confidence in the treatment predict symptomatic improvement week by week in therapy: A latent curve modeling approach. J Couns Psychol. 2022 Nov;69(6):823-834. doi: 10.1037/cou0000640. Epub 2022 Sep 22.
PubMed 36136794Finsrud I, Nissen-Lie HA, Vrabel K, Hostmaelingen A, Wampold BE, Ulvenes PG. It's the therapist and the treatment: The structure of common therapeutic relationship factors. Psychother Res. 2022 Feb;32(2):139-150. doi: 10.1080/10503307.2021.1916640. Epub 2021 May 2.
PubMed 33938407
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Change Mechanisms in Psychotherapy: Relationship Between Specific Ingredients and Common Factors in Promoting Change.
- ClinicalTrials.gov ID
- NCT03503981
- Acronym / sponsor ID
- CAMP / CAMPFinsrud
- Conditions
- Psychological Disorder, Anxiety Disorders, Depression, Eating Disorder, Post Traumatic Stress Disorder
- Keywords
- Process-outcome study, Mechanisms of change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 20 Aug 2020 (estimated)
- Study completion
- 20 Aug 2021 (estimated)
- First posted
- 20 Apr 2018 (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.
This research project seeks to acquire a deeper understanding of the complex influences of common factors and specific ingredients in psychotherapy. By using frequent process-outcome measures, it will address individualized mechanisms of change in psychotherapy by assessing both between and within patient change processes, using a wide spectrum of change indicators.
Detailed description
The study is a naturalistic study conducted by collecting data from in-patient units at Modum Bad (psychiatric hospital). The sample includes different patient groups with a variety of psychological disorders. Further, sample is gathered from units using different treatment approaches (short-term psychodynamic treatment, cognitive-behavioral treatment, metacognitive therapy, compassion-focused therapy, relational psychodynamic therapy, existential therapy and stabilizing trauma-therapy).
The following specific research questions will be explored:
- The role of common factors:
- What are the relative influences of different common factors such as agreement on task and goals, treatment credibility and 'the real relationship', across treatments and diagnoses?
- Do some common factor variables stand out regarding ability to explain variance in outcome and across outcomes?
- Do measures of common factors have a consistent effect on outcome across treatment models and diagnoses, or does the explanatory value of common factors vary across diagnose and treatment model?
- The role of specific change mechanisms (affective, cognitive and meta-cognitive):
- To what extent do specific change mechanisms predict change in various outcome domains?
- Are these specific change mechanisms equally important predictors, or do they vary across treatment or diagnose?
- Are there interaction effects between common factors and specific factors across treatment models, patient diagnoses and outcome domain?
Self-report data will be collected three times a week on mechanisms of change and symptoms, established by psychotherapy theory and research evidence as important for psychological change. The data collection consists of three different forms administered once per week on different days. The forms are separated by topic; symptoms, contextual factors, and change processes. The questions in the forms are selected from short instruments with good psychometric qualities. The data collection procedure has at present been tested on five patient cohorts with good results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anxiety unit | – | Other: PsychotherapyPatients have anxiety as a primary diagnose. Receive treatment for anxiety (CBT and MCT). |
| Eating disorder unit | – | Other: PsychotherapyPatients have eating disorder as primary diagnose. Receive treatment for their eating disorder (CBT and compassion-focused therapy). |
| Depression unit | – | Other: PsychotherapyPatients have depression as primary disorder. Receive treatment for their depression (Short-term dynamic therapy, existential therapy and relational psychodynamic therapy). |
| Family unit | – | Other: PsychotherapyOne of the members of the family has a psychological disorder. The treatment is focused towards the family and family dynamics. |
| Trauma unit | – | Other: PsychotherapyPatients have PTSD and relational trauma as primary diagnosis. Receive stabilizing treatment and exposure therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients accepted for inpatient treatment at Modum Bad Psychiatric hospital during the time of data collection will participate in this study, contingent on consent. The patients included will be all genders, adults and reciving treatment from specialist health care.
Key inclusion criteria (6 listed)
- Must be a patient at Modum Bad
- Have a psychological disorder
- Must have rights to treatment according to the rules of specialist health care in Norway. Includes the following:
Key exclusion criteria (3 listed)
- Acute suicidality
- Ongoing/active abuse of harmful drug(s)
- Under 18 years
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 |
|---|---|---|
| PsychotherapyThere are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups. | Other | Anxiety unit, Depression unit, Eating disorder unit, Family unit, Trauma unit |
Primary outcome
Symptom checklist revised (SCL-90-R)
Time frame: Change measure (baseline, 14 weeks, and 12 months).
A general measure of symptoms distress
8 secondary outcomes
Inventory of interpersonal problems
Time frame: Change measure (baseline, 14 weeks, and 12 months).
Beck's depression inventory
Time frame: Change measure (baseline, 14 weeks, and 12 months).
PTSD checklist for Diagnostic and Statistical Manual 5 (PCL-5)
Time frame: Change measure (baseline, 14 weeks, and 12 months).
M-POQ outcome, anxiety
Time frame: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, depression
Time frame: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, loneliness
Time frame: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, resilience
Time frame: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
M-POQ outcome, well-being
Time frame: Change measure (baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks and 14 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Derived from this study: PubMed 42775480Johansen FT, Finsrud I, Flo-Groeneboom E, Kvamme IR. Transformative pathways: shame and fear of compassion as potential mechanisms of change in psychotherapy. Psychother Res. 2026 Sep 23:1-13. doi: 10.1080/10503307.2026.2732028. Online ahead of print.
- Derived from this study: PubMed 36136794Finsrud I, Nissen-Lie HA, Ulvenes P, Melsom L, Vrabel K, Wampold B. Confidence in the therapist and confidence in the treatment predict symptomatic improvement week by week in therapy: A latent curve modeling approach. J Couns Psychol. 2022 Nov;69(6):823-834. doi: 10.1037/cou0000640. Epub 2022 Sep 22.
- Derived from this study: PubMed 33938407Finsrud I, Nissen-Lie HA, Vrabel K, Hostmaelingen A, Wampold BE, Ulvenes PG. It's the therapist and the treatment: The structure of common therapeutic relationship factors. Psychother Res. 2022 Feb;32(2):139-150. doi: 10.1080/10503307.2021.1916640. Epub 2021 May 2.
- Individual participant dataSharing planned: No
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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 Psychological Disorder and Anxiety Disorders, run by Modum Bad 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 6 inclusion and 3 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 20 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingvild Finsrud, Master degree (95899278 ext. 0047, ingvilfi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom checklist revised (SCL-90-R) (time frame: Change measure (baseline, 14 weeks, and 12 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 NCT03503981, which also lists 3 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 20 Apr 2018; AzTrials last refreshed its copy on 29 Oct 2026.