Clinical trial NCT03503981: Examining Change Mechanisms in Psychotherapy
Official title: Examining Change Mechanisms in Psychotherapy: Relationship Between Specific Ingredients and Common Factors in Promoting Change.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychological Disorder
Anxiety Disorders
Depression
Eating Disorder
Post Traumatic Stress Disorder
Keywords: Process-outcome study
Mechanisms of change
Lead sponsor: Modum Bad
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2018-04-20
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Symptom checklist revised (SCL-90-R)
timeFrame: Change measure (baseline, 14 weeks, and 12 months).
Secondary outcomes:
measure: Inventory of interpersonal problems
timeFrame: Change measure (baseline, 14 weeks, and 12 months).
measure: Beck's depression inventory
timeFrame: Change measure (baseline, 14 weeks, and 12 months).
measure: PTSD checklist for Diagnostic and Statistical Manual 5 (PCL-5)
timeFrame: Change measure (baseline, 14 weeks, and 12 months).
measure: M-POQ outcome, anxiety
timeFrame: 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).
measure: M-POQ outcome, depression
timeFrame: 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).
measure: M-POQ outcome, loneliness
timeFrame: 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).
measure: M-POQ outcome, resilience
timeFrame: 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).
measure: M-POQ outcome, well-being
timeFrame: 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).
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
state: Buskerud
Study officials:
References:
citation: 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.
citation: 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.