Examining Change Mechanisms in Psychotherapy

NCT ID: NCT03503981

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2021-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. The role of common factors:

1. 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?
2. Do some common factor variables stand out regarding ability to explain variance in outcome and across outcomes?
3. 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?
2. The role of specific change mechanisms (affective, cognitive and meta-cognitive):

1. To what extent do specific change mechanisms predict change in various outcome domains?
2. Are these specific change mechanisms equally important predictors, or do they vary across treatment or diagnose?
3. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Disorder Anxiety Disorders Depression Eating Disorder Post Traumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anxiety unit

Patients have anxiety as a primary diagnose. Receive treatment for anxiety (CBT and MCT).

Psychotherapy

Intervention Type OTHER

There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Eating disorder unit

Patients have eating disorder as primary diagnose. Receive treatment for their eating disorder (CBT and compassion-focused therapy).

Psychotherapy

Intervention Type OTHER

There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Depression unit

Patients have depression as primary disorder. Receive treatment for their depression (Short-term dynamic therapy, existential therapy and relational psychodynamic therapy).

Psychotherapy

Intervention Type OTHER

There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Family unit

One of the members of the family has a psychological disorder. The treatment is focused towards the family and family dynamics.

Psychotherapy

Intervention Type OTHER

There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Trauma unit

Patients have PTSD and relational trauma as primary diagnosis. Receive stabilizing treatment and exposure therapy.

Psychotherapy

Intervention Type OTHER

There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychotherapy

There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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:

1. Patient is expected to have poorer prognosis of life quality if not given treatment
2. It is expected that the patient will benefit from treatment
3. It is expected that there is a reasonable cost-effect balance regarding the treatment given and the patient's benefit from treatment.

Exclusion Criteria

* Acute suicidality
* Ongoing/active abuse of harmful drug(s)
* Under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role collaborator

Modum Bad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Modum Bad

Vikersund, Buskerud, Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ingvild Finsrud, Master degree

Role: CONTACT

95899278 ext. 0047

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Terje Tilden, PhD

Role: primary

32749869 ext. 0047

References

Explore related publications, articles, or registry entries linked to this study.

Finsrud 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.

Reference Type DERIVED
PMID: 36136794 (View on PubMed)

Finsrud 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.

Reference Type DERIVED
PMID: 33938407 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAMPFinsrud

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.