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Examining Change Mechanisms in Psychotherapy (CAMP)

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

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 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

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503981


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

Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT03503981     History of Changes
Other Study ID Numbers: CAMPFinsrud
First Posted: April 20, 2018    Key Record Dates
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
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Feeding and Eating Disorders
Mental Disorders
Pathologic Processes
Trauma and Stressor Related Disorders