Clinical trial NCT04779437: Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work
Official title: Using Bayesian Sequential Single Case Methodology to Personalize Low-Intensity Psychological Interventions for Depression: Initial Pilot Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Anhedonia
Cognitive Bias Modification
Cognitive Control Training
Bayesian sequential analyses
Single case series
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is an exploratory single-case series using a within-subject ABC design, with a baseline phase (A) followed by two intervention phases (B) and (C). Participants are randomly assigned to the order in which they complete the two different interventions.
Primary purpose: TREATMENT

Brief summary: The study is an initial investigation of the feasibility of applying Bayesian sequential analyses to individual participant single-case data for rapid detection of whether or not the individual is benefitting from a low-intensity computerized cognitive training intervention for depression. Patients waiting for, or in follow-up from, outpatient psychological therapy will complete first a two-week period of daily symptom monitoring, followed by two different two-week cognitive training interventions. Data collected will be used to assess feasibility of a future formal case series using Bayesian sequential analyses to determine switching of interventions, and inform the analysis parameters for such a future study.


Eligibility criteria: Inclusion Criteria:

* Patient registered at the Ruhr University of Bochum Outpatient Psychotherapy Center ("Zentrum für Psychotherapie", ZPT) in an appropriate phase of treatment (on waiting list/ in follow-up), or from 26/10/22 having had a first consultation ("Beratungsgespräch")
* Aged 18 years or above
* Owning a technical device (e.g. a laptop, computer) that is compatible with the computerized training
* Scoring ≥ 6 on the QIDS (indicating at least mild levels of depressive symptoms)
* Willing and able to complete all study procedures

Exclusion Criteria:

* Existence of a condition or circumstances that would interfere with completion of the study procedures (e.g. severe visual impairment, neurological problem, acute psychosis, or substance withdrawal symptoms)
* Acute crisis with high levels of suicidal ideations or high levels of self-harm, identified either through therapist's assessment or score \>1 on item 12 of the QIDS

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)
timeFrame: End of intervention (4 weeks post-baseline)
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report (QIDS)
timeFrame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: Positive and Negative Affect Schedule - Positive subscale (PANAS-P)
timeFrame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: GAD-7
timeFrame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: Positive Mental Health Scale (PMH)
timeFrame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: Prospective Imagery Test (PIT)
timeFrame: Baseline, end of study (6 weeks post-baseline)
measure: Daily Expressions of Psychopathology (DEP)
timeFrame: End of intervention (4 weeks post-baseline)
Other outcomes:
measure: Feedback questionnaires
timeFrame: Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)
measure: Credibility / Expectancy Questionnaires (CEQ)
timeFrame: Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline)
Locations:
city: Bochum
country: Germany
facility: Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of Bochum
state: Nordrhein-Westfalen
Study officials:
affiliation: Ruhr-Universität Bochum
name: Simon E Blackwell, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References: