NCT03503981

Brief 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 processes, using a wide spectrum of change indicators.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2.9 years

First QC Date

January 25, 2018

Last Update Submit

April 11, 2018

Conditions

Keywords

Process-outcome studyMechanisms of change

Outcome Measures

Primary Outcomes (1)

  • Symptom checklist revised (SCL-90-R)

    A general measure of symptoms distress

    Change measure (baseline, 14 weeks, and 12 months).

Secondary Outcomes (8)

  • Inventory of interpersonal problems

    Change measure (baseline, 14 weeks, and 12 months).

  • Beck's depression inventory

    Change measure (baseline, 14 weeks, and 12 months).

  • PTSD checklist for Diagnostic and Statistical Manual 5 (PCL-5)

    Change measure (baseline, 14 weeks, and 12 months).

  • M-POQ outcome, anxiety

    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

    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).

  • +3 more secondary outcomes

Study Arms (5)

Anxiety unit

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

Other: Psychotherapy

Eating disorder unit

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

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).

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.

Other: Psychotherapy

Trauma unit

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

Other: Psychotherapy

Interventions

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

Anxiety unitDepression unitEating disorder unitFamily unitTrauma unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Acute suicidality
  • Ongoing/active abuse of harmful drug(s)
  • Under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Modum Bad

Vikersund, Buskerud, 3370, Norway

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Mental DisordersAnxiety DisordersDepressionFeeding and Eating DisordersStress Disorders, Post-Traumatic

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Ingvild Finsrud, Master degree

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

April 20, 2018

Study Start

September 15, 2017

Primary Completion

August 20, 2020

Study Completion

August 20, 2021

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations