NCT02958228

Brief Summary

The purpose of this randomized controlled trial is to establish feasibility and provide initial estimates of efficacy of two computerized cognitive training procedures (a form of Positive Mental Imagery Training, PMIT, and a form of Cognitive Control Training, CCT) delivered as adjuncts to treatment as usual (TAU) in inpatient mental health treatment settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

November 4, 2016

Last Update Submit

March 27, 2018

Conditions

DepressionAnxietyAnhedonia

Keywords

Positive AffectMental ImageryCognitive Bias ModificationCognitive Control Training

Outcome Measures

Primary Outcomes (1)

  • 21-item positive subscale from the extended Positive and Negative Affect Schedules

    The Joviality, Self-Assurance, Attentiveness, and Serenity subscales of the extended PANAS (PANAS-X; Watson \& Clark, 1994) will be administered, following previous experimental research examining the effect of positive mental imagery on state mood (e.g. Holmes, Lang, \& Shah, 2009). Participants will be asked to rate the items according to how they have been feeling 'in the past week, that is, during the past seven days, including today'.

    Post-intervention (2 weeks post-baseline)

Secondary Outcomes (8)

  • 21-item positive subscale from the extended Positive and Negative Affect Schedules

    Baseline, Follow-up (2 weeks after the post-intervention assessment)

  • Dimensional Anhedonia Rating Scale

    Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)

  • Quick Inventory of Depressive Symptomatology - Self Report

    Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)

  • GAD-7

    Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)

  • Positive Mental Health Scale

    Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)

  • +3 more secondary outcomes

Other Outcomes (4)

  • Self-report mood/cognitions over the previous day (Likert scales)

    Baseline, up to 2 weeks post-baseline

  • State mood pre and post each training session (Likert scales)

    Baseline, up to 2 weeks post-baseline

  • Credibility/Expectancy Questionnaire

    Baseline

  • +1 more other outcomes

Study Arms (3)

Positive Mental Imagery Training (PMIT)

EXPERIMENTAL

Computerized Positive Mental Imagery Training (PMIT), a form of mental imagery-based cognitive bias modification adapted from previous experimental (e.g. Holmes, Lang, \& Shah, 2009) and clinical (e.g. Blackwell \& Holmes, 2010) work. The intervention consists of 8 sessions completed over a period of 2 weeks. The training takes place alongside participants' treatment as usual (TAU) in the inpatient setting.

Behavioral: Positive Mental Imagery Training (PMIT)Other: Treatment as Usual

Cognitive Control Training (CCT)

ACTIVE COMPARATOR

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). The intervention consists of 8 sessions completed over a period of 2 weeks. The training takes place alongside participants' treatment as usual (TAU) in the inpatient setting.

Behavioral: Cognitive Control Training (CCT)Other: Treatment as Usual

Treatment as Usual

ACTIVE COMPARATOR

Participants will receive their treatment as usual (TAU) within the inpatient setting, which may include group/individual psychological therapy, a range of therapeutic activities, and pharmacological treatment.

Other: Treatment as Usual

Interventions

Positive Mental Imagery Training (PMIT)BEHAVIORAL
Positive Mental Imagery Training (PMIT)
Cognitive Control Training (CCT)BEHAVIORAL
Cognitive Control Training (CCT)
Treatment as UsualOTHER
Cognitive Control Training (CCT)Positive Mental Imagery Training (PMIT)Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or above
  • Sufficient German language skills
  • Receiving treatment in a participating inpatient clinic during the timeframe of the study (i.e. they must be able to complete the training entirely within their admission).

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nexus-Klinik

Baden-Baden, 76530, Germany

Location

St. Marien Hospital Eickel

Herne, 44649, Germany

Location

Related Publications (1)

  • Blackwell SE, Westermann K, Woud ML, Cwik JC, Neher T, Graz C, Nyhuis PW, Margraf J. Computerized positive mental imagery training versus cognitive control training versus treatment as usual in inpatient mental health settings: study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2018 Aug 4;4:133. doi: 10.1186/s40814-018-0325-1. eCollection 2018.

    PMID: 30123524DERIVED

MeSH Terms

Conditions

DepressionAnxiety DisordersAnhedonia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simon E Blackwell, DClinPsych

    Ruhr University of Bochum

    PRINCIPAL INVESTIGATOR

  • Jürgen Margraf, PhD

    Ruhr University of Bochum

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Assistant

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

It is planned to make individual participant data available on publication of the associated study results, via a publicly-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.

Locations

DE(2)