Back to resultsThe Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
Primary Purpose
Depression, Anxiety, Anhedonia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Positive Mental Imagery Training (PMIT)
Cognitive Control Training (CCT)
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Positive Affect, Mental Imagery, Cognitive Bias Modification, Cognitive Control Training
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)
Sites / Locations
- Nexus-Klinik
- St. Marien Hospital Eickel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Positive Mental Imagery Training (PMIT)
Cognitive Control Training (CCT)
Treatment as Usual
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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'.
Secondary Outcome Measures
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'.
Dimensional Anhedonia Rating Scale
An extended 26-item version of the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015) will be administered.
Quick Inventory of Depressive Symptomatology - Self Report
GAD-7
Positive Mental Health Scale
Prospective Imagery Test
Scrambled Sentences Test (SST)
Implicit Associations Test (IAT)
Full Information
NCT ID
NCT02958228
First Posted
November 4, 2016
Last Updated
March 27, 2018
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT02958228
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Anhedonia
Keywords
Positive Affect, Mental Imagery, Cognitive Bias Modification, Cognitive Control Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive Mental Imagery Training (PMIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Control Training (CCT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Mental Imagery Training (PMIT)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Control Training (CCT)
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
21-item positive subscale from the extended Positive and Negative Affect Schedules
Description
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'.
Time Frame
Post-intervention (2 weeks post-baseline)
Secondary Outcome Measure Information:
Title
21-item positive subscale from the extended Positive and Negative Affect Schedules
Description
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'.
Time Frame
Baseline, Follow-up (2 weeks after the post-intervention assessment)
Title
Dimensional Anhedonia Rating Scale
Description
An extended 26-item version of the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015) will be administered.
Time Frame
Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Title
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)
Title
GAD-7
Time Frame
Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Title
Positive Mental Health Scale
Time Frame
Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Title
Prospective Imagery Test
Time Frame
Baseline, Post-intervention (2 weeks post-baseline)
Title
Scrambled Sentences Test (SST)
Time Frame
Baseline, Post-intervention (2 weeks post-baseline)
Title
Implicit Associations Test (IAT)
Time Frame
Baseline, Post-intervention (2 weeks post-baseline)
Other Pre-specified Outcome Measures:
Title
Self-report mood/cognitions over the previous day (Likert scales)
Description
Ratings will be made up to 8 times over the two-week intervention period (between baseline and post-intervention)
Time Frame
Baseline, up to 2 weeks post-baseline
Title
State mood pre and post each training session (Likert scales)
Description
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.
Time Frame
Baseline, up to 2 weeks post-baseline
Title
Credibility/Expectancy Questionnaire
Time Frame
Baseline
Title
Feedback Questionnaire
Time Frame
Follow-up (2 weeks after the post-intervention assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon E Blackwell, DClinPsych
Organizational Affiliation
Ruhr University of Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jürgen Margraf, PhD
Organizational Affiliation
Ruhr University of Bochum
Official's Role
Study Chair
Facility Information:
Facility Name
Nexus-Klinik
City
Baden-Baden
ZIP/Postal Code
76530
Country
Germany
Facility Name
St. Marien Hospital Eickel
City
Herne
ZIP/Postal Code
44649
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30123524
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.
Results Reference
derived
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The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
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