Examining Change Mechanisms in Psychotherapy (CAMP)

• ClinicalTrials.gov Identifier: NCT03503981
• Recruitment Status: Unknown
• First Posted: April 20, 2018
• Last Update Posted: April 20, 2018
• Sponsor: Modum Bad
• Collaborator: University of Oslo
• Information provided by (Responsible Party): Modum Bad

Study Description

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.

Condition or disease	Intervention/treatment
Psychological Disorder; Anxiety Disorders; Depression; Eating Disorder; Post Traumatic Stress Disorder	Other: Psychotherapy

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:

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 520 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Examining Change Mechanisms in Psychotherapy: Relationship Between Specific Ingredients and Common Factors in Promoting Change.
• Actual Study Start Date: September 15, 2017
• Estimated Primary Completion Date: August 20, 2020
• Estimated Study Completion Date: August 20, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Anxiety unit; Patients have anxiety as a primary diagnose. Receive treatment for anxiety (CBT and MCT).	Other: Psychotherapy; 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).	Other: Psychotherapy; 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).	Other: Psychotherapy; 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.	Other: Psychotherapy; 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.	Other: Psychotherapy; There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.

Outcome Measures

Primary Outcome Measures :

1. Symptom checklist revised (SCL-90-R) [ Time Frame: Change measure (baseline, 14 weeks, and 12 months). ]
   A general measure of symptoms distress

Secondary Outcome Measures :

1. Inventory of interpersonal problems [ Time Frame: Change measure (baseline, 14 weeks, and 12 months). ]
   Self-report questionnaire of interpersonal problems
2. Beck's depression inventory [ Time Frame: Change measure (baseline, 14 weeks, and 12 months). ]
   Measure of depressive symptoms
3. PTSD checklist for Diagnostic and Statistical Manual 5 (PCL-5) [ Time Frame: Change measure (baseline, 14 weeks, and 12 months). ]
   PTSD symptom measure
4. 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). ]
   Measures anxiety symptoms
5. 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). ]
   Measures depression symptoms
6. 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). ]
   Measures experienced loneliness
7. 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). ]
   Measures experienced recilience
8. 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). ]
   Measures experienced well-being

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-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.

Criteria

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

Contacts and Locations

Contacts

Contact: Ingvild Finsrud, Master degree; 95899278 ext 0047; ingvilfi@gmail.com

Locations

Norway

Modum Bad; Recruiting

Vikersund, Buskerud, Norway, 3370

Contact: Terje Tilden, PhD 32749869 ext 0047 tilden@modum-bad.no

Principal Investigator: Ingvild Finsrud, Master

Sponsors and Collaborators

Modum Bad

University of Oslo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Finsrud I, Nissen-Lie HA, Vrabel K, Høstmælingen 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.

• Responsible Party: Modum Bad
• ClinicalTrials.gov Identifier: NCT03503981
• Other Study ID Numbers: CAMPFinsrud
• First Posted: April 20, 2018
• Last Update Posted: April 20, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Modum Bad:

Process-outcome study; Mechanisms of change

Additional relevant MeSH terms:

Disease; Stress Disorders, Traumatic; Anxiety Disorders; Stress Disorders, Post-Traumatic; Feeding and Eating Disorders; Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders