Bayesian Sequential Single Case Methods to Personalize Low-Intensity Psychological Interventions: Initial Pilot Work

NCT04779437 | Completed

• 1 other identifier: 650
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Anhedonia; Cognitive Bias Modification; Cognitive Control Training; Bayesian sequential analyses; Single case series

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology - Self Report Daily Version (QIDS-daily)

  The QIDS-daily is an adapted version of the QIDS-SR (Rush et al., 2003), which asks about symptoms over the past day and does not include the weight gain/loss items (as used by Holmes et al., 2016). The QIDS-daily will be completed daily over the entire study period, and we will compare the mean and slope of the daily QIDS over the intervention phase to the mean and slope of the daily QIDS in the previous phase.

  End of intervention (4 weeks post-baseline)

Secondary Outcomes (7)

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS)

  Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

• Dimensional Anhedonia Rating Scale (DARS)

  Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

• Positive and Negative Affect Schedule - Positive subscale (PANAS-P)

  Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

• GAD-7

  Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

• Positive Mental Health Scale (PMH)

  Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

Other Outcomes (3)

• Feedback questionnaires

  Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

• Negative Effects Questionnaire (NEQ)

  Between interventions (4 weeks post-baseline), end of study (6 weeks post-baseline)

• Credibility / Expectancy Questionnaires (CEQ)

  Baseline, pre-intervention (2 weeks post-baseline), between interventions (4 weeks post-baseline)

Study Arms (2)

Imagery Cognitive Bias Modification First

EXPERIMENTAL

After completing two weeks of daily QIDS (baseline phase), participants randomly allocated to this arm will complete two weeks of imagery cognitive bias modification followed by two weeks of cognitive control training. Daily QIDS will be completed throughout the intervention phases.

Behavioral: Imagery Cognitive Bias Modification; Behavioral: Cognitive Control Training

Cognitive Control Training First

EXPERIMENTAL

After completing two weeks of daily QIDS (baseline phase), participants randomly allocated to this arm will complete two weeks of cognitive control training followed by two weeks of imagery cognitive bias modification. Daily QIDS will be completed throughout the intervention phases.

Behavioral: Imagery Cognitive Bias Modification; Behavioral: Cognitive Control Training

Interventions

Imagery Cognitive Bias Modification BEHAVIORAL

The imagery cognitive bias modification intervention is derived from that developed via experimental psychopathology research (e.g. Holmes et al., 2009) and adapted for clinical applications in the context of depression (e.g. Blackwell \& Holmes, 2010; Blackwell et al., 2015). The intervention is a series of training sessions in which participants listen to training scenarios consisting of descriptions of everyday situations, structured so that they start ambiguously but always end positively. Participants are instructed to imagine themselves in the situations described as the scenarios unfold. The training aims to train a bias to automatically imagine positive resolutions for ambiguous situations encountered in daily life. Participants will complete one introductory session of the training with the researcher present (in the outpatient center, or via videoconferencing software), then 8 sessions over two weeks completed from home via the study website.

Cognitive Control Training First; Imagery Cognitive Bias Modification First

Cognitive Control Training BEHAVIORAL

The cognitive control training is an adaptive Paced Auditory Serial Addition Task (PASAT), adapted from that applied in previous studies (e.g. Siegle et al., 2007; Hoorelbeke et al., 2015; Blackwell et al., 2018). Participants will complete one introductory session of the training with the researcher present (in the outpatient center, or via videoconferencing software), then 8 sessions over two weeks completed from home via the study website.

Cognitive Control Training First; Imagery Cognitive Bias Modification First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Zentrum für Psychotherapie [Center for Psychotherapy], Mental Health Research and Treatment Center, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, 44787, Germany

Location

MeSH Terms

Conditions

Depression; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon E Blackwell, Dr. phil.

  Ruhr-Universität Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Two active interventions are used, and both participants and researchers are aware of which intervention participants are completing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 3, 2021
• Study Start: March 17, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Supporting information will be made available on publication via a suitable repository such as the Open Science Framework, and will be made available to reviewers at the time of submission (or publically with a pre-print version of the manuscript).

Locations

DE (1)