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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03503981
Other study ID # CAMPFinsrud
Secondary ID
Status Recruiting
Phase
First received January 25, 2018
Last updated April 11, 2018
Start date September 15, 2017
Est. completion date August 20, 2021

Study information

Verified date April 2018
Source Modum Bad
Contact Ingvild Finsrud, Master degree
Phone 95899278
Email ingvilfi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 processes, using a wide spectrum of change indicators.


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:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date August 20, 2021
Est. primary completion date August 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Norway Modum Bad Vikersund Buskerud

Sponsors (2)

Lead Sponsor Collaborator
Modum Bad University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom checklist revised (SCL-90-R) A general measure of symptoms distress Change measure (baseline, 14 weeks, and 12 months).
Secondary Inventory of interpersonal problems Self-report questionnaire of interpersonal problems Change measure (baseline, 14 weeks, and 12 months).
Secondary Beck's depression inventory Measure of depressive symptoms Change measure (baseline, 14 weeks, and 12 months).
Secondary PTSD checklist for Diagnostic and Statistical Manual 5 (PCL-5) PTSD symptom measure Change measure (baseline, 14 weeks, and 12 months).
Secondary M-POQ outcome, anxiety Measures anxiety symptoms 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).
Secondary M-POQ outcome, depression Measures depression symptoms 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).
Secondary M-POQ outcome, loneliness Measures experienced loneliness 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).
Secondary M-POQ outcome, resilience Measures experienced recilience 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).
Secondary M-POQ outcome, well-being Measures experienced well-being 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).
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