The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anhedonia; Anxiety
• Intervention / Treatment: Behavioral: Positive Mental Imagery Training (PMIT); Other: Treatment as Usual; Behavioral: Cognitive Control Training (CCT)

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Baden, Germany, 76530
    • Nexus-Klinik
  • Herne, Germany, 44649
    • St. Marien Hospital Eickel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Mental Imagery Training (PMIT); 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
Active Comparator: Cognitive Control Training (CCT); 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.	Other: Treatment as Usual; Behavioral: Cognitive Control Training (CCT)
Active Comparator: Treatment as Usual; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	Baseline, Follow-up (2 weeks after the post-intervention assessment)
Dimensional Anhedonia Rating Scale	An extended 26-item version of the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015) will be administered.	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)
Prospective Imagery Test		Baseline, Post-intervention (2 weeks post-baseline)
Scrambled Sentences Test (SST)		Baseline, Post-intervention (2 weeks post-baseline)
Implicit Associations Test (IAT)		Baseline, Post-intervention (2 weeks post-baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report mood/cognitions over the previous day (Likert scales)	Ratings will be made up to 8 times over the two-week intervention period (between baseline and post-intervention)	Baseline, up to 2 weeks post-baseline
State mood pre and post each training session (Likert scales)	Ratings of state mood will be made pre and post each session of PMIT or CCT by participants in the Positive Mental Imagery Training and Cognitive Control Training arms.	Baseline, up to 2 weeks post-baseline
Credibility/Expectancy Questionnaire		Baseline
Feedback Questionnaire		Follow-up (2 weeks after the post-intervention assessment)

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Simon E Blackwell, DClinPsych, Ruhr University of Bochum; Study Chair: Jürgen Margraf, PhD, Ruhr University of Bochum

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Positive Affect; Cognitive Control Training; Cognitive Bias Modification; Mental Imagery
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Anhedonia
• Other Study ID Numbers: 325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.