Clinical trial NCT02958228: The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
Official title: The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Anhedonia
Keywords: Positive Affect
Mental Imagery
Cognitive Bias Modification
Cognitive Control Training
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

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)

Primary outcomes:
measure: 21-item positive subscale from the extended Positive and Negative Affect Schedules
timeFrame: Post-intervention (2 weeks post-baseline)
Secondary outcomes:
measure: 21-item positive subscale from the extended Positive and Negative Affect Schedules
timeFrame: Baseline, Follow-up (2 weeks after the post-intervention assessment)
measure: Dimensional Anhedonia Rating Scale
timeFrame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
measure: Quick Inventory of Depressive Symptomatology - Self Report
timeFrame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
measure: GAD-7
timeFrame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
measure: Positive Mental Health Scale
timeFrame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
measure: Prospective Imagery Test
timeFrame: Baseline, Post-intervention (2 weeks post-baseline)
measure: Scrambled Sentences Test (SST)
timeFrame: Baseline, Post-intervention (2 weeks post-baseline)
measure: Implicit Associations Test (IAT)
timeFrame: Baseline, Post-intervention (2 weeks post-baseline)
Other outcomes:
measure: Self-report mood/cognitions over the previous day (Likert scales)
timeFrame: Baseline, up to 2 weeks post-baseline
measure: State mood pre and post each training session (Likert scales)
timeFrame: Baseline, up to 2 weeks post-baseline
measure: Credibility/Expectancy Questionnaire
timeFrame: Baseline
measure: Feedback Questionnaire
timeFrame: Follow-up (2 weeks after the post-intervention assessment)
Locations:
city: Baden-Baden
country: Germany
facility: Nexus-Klinik
city: Herne
country: Germany
facility: St. Marien Hospital Eickel
Study officials:
affiliation: Ruhr University of Bochum
name: Simon E Blackwell, DClinPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr University of Bochum
name: Jürgen Margraf, PhD
role: STUDY_CHAIR
References:
citation: 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.