Examining Change Mechanisms in Psychotherapy

Depression Clinical Trial

— CAMP  

Official title:

Examining Change Mechanisms in Psychotherapy: Relationship Between Specific Ingredients and Common Factors in Promoting Change.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03503981
• Other study ID #: CAMPFinsrud
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Disease
• Eating Disorder
• Feeding and Eating Disorders
• Mental Disorders
• Post Traumatic Stress Disorder
• Psychological Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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).