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

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ClinicalTrials.gov Identifier: NCT02958228
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Simon Blackwell, Ruhr University of Bochum

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Anhedonia Behavioral: Positive Mental Imagery Training (PMIT) Behavioral: Cognitive Control Training (CCT) Other: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
Actual Study Start Date : November 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 21-item positive subscale from the extended Positive and Negative Affect Schedules [ Time Frame: Post-intervention (2 weeks post-baseline) ]
    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'.


Secondary Outcome Measures :
  1. 21-item positive subscale from the extended Positive and Negative Affect Schedules [ Time Frame: Baseline, Follow-up (2 weeks after the post-intervention assessment) ]
    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'.

  2. Dimensional Anhedonia Rating Scale [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment) ]
    An extended 26-item version of the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015) will be administered.

  3. Quick Inventory of Depressive Symptomatology - Self Report [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment) ]
  4. GAD-7 [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment) ]
  5. Positive Mental Health Scale [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment) ]
  6. Prospective Imagery Test [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline) ]
  7. Scrambled Sentences Test (SST) [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline) ]
  8. Implicit Associations Test (IAT) [ Time Frame: Baseline, Post-intervention (2 weeks post-baseline) ]

Other Outcome Measures:
  1. Self-report mood/cognitions over the previous day (Likert scales) [ Time Frame: Baseline, up to 2 weeks post-baseline ]
    Ratings will be made up to 8 times over the two-week intervention period (between baseline and post-intervention)

  2. State mood pre and post each training session (Likert scales) [ Time Frame: Baseline, up to 2 weeks post-baseline ]
    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.

  3. Credibility/Expectancy Questionnaire [ Time Frame: Baseline ]
  4. Feedback Questionnaire [ Time Frame: Follow-up (2 weeks after the post-intervention assessment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958228


Locations
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Germany
Nexus-Klinik
Baden-Baden, Germany, 76530
St. Marien Hospital Eickel
Herne, Germany, 44649
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Simon E Blackwell, DClinPsych Ruhr University of Bochum
Study Chair: Jürgen Margraf, PhD Ruhr University of Bochum
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simon Blackwell, Postdoctoral Research Assistant, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02958228    
Other Study ID Numbers: 325
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Simon Blackwell, Ruhr University of Bochum:
Positive Affect
Mental Imagery
Cognitive Bias Modification
Cognitive Control Training
Additional relevant MeSH terms:
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Anhedonia
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases