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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02958228
Other study ID # 325
Secondary ID
Status Completed
Phase N/A
First received November 4, 2016
Last updated March 27, 2018
Start date November 2016
Est. completion date March 2018

Study information

Verified date March 2018
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Positive Mental Imagery Training (PMIT)

Cognitive Control Training (CCT)

Other:
Treatment as Usual


Locations

Country Name City State
Germany Nexus-Klinik Baden-Baden
Germany St. Marien Hospital Eickel Herne

Sponsors (1)

Lead Sponsor Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other Credibility/Expectancy Questionnaire Baseline
Other Feedback Questionnaire Follow-up (2 weeks after the post-intervention assessment)
Primary 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 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)
Secondary 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)
Secondary Quick Inventory of Depressive Symptomatology - Self Report Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Secondary GAD-7 Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Secondary Positive Mental Health Scale Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Secondary Prospective Imagery Test Baseline, Post-intervention (2 weeks post-baseline)
Secondary Scrambled Sentences Test (SST) Baseline, Post-intervention (2 weeks post-baseline)
Secondary Implicit Associations Test (IAT) Baseline, Post-intervention (2 weeks post-baseline)
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