DepressionNCT02958228
The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
A study testing Positive Mental Imagery Training (PMIT) and Treatment as Usual in people with Depression and Anxiety, run by Ruhr University of Bochum at 2 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Anhedonia
- What is being tested?
- Positive Mental Imagery Training (PMIT) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Nexus-Klinik
Baden-Baden, 76530
St. Marien Hospital Eickel
Herne, 44649
About this study
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.
- Conditions
- Depression, Anxiety, Anhedonia
- Being tested
- Positive Mental Imagery Training (PMIT), Cognitive Control Training (CCT), Treatment as Usual
- Keywords
- Positive Affect, Mental Imagery, Cognitive Bias Modification, Cognitive Control Training
- Medical subject headings
- Depression, Anxiety Disorders, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Mental Imagery Training (PMIT)Behavioural
Cognitive Control Training (CCT)Behavioural
Treatment as UsualOther
| Study group | Role | What they receive |
|---|---|---|
| Positive Mental Imagery Training (PMIT) | Experimental | 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. Receives: Behavioral: Positive Mental Imagery Training (PMIT); Other: Treatment as Usual |
| Cognitive Control Training (CCT) | Active comparator | 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. Receives: Behavioral: Cognitive Control Training (CCT); Other: Treatment as Usual |
| Treatment as Usual | Active comparator | 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Post-intervention (2 weeks post-baseline)
Secondary outcomes (8)
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'.
Measured: 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.
Measured: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Quick Inventory of Depressive Symptomatology - Self Report
Measured: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
GAD-7
Measured: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Positive Mental Health Scale
Measured: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Prospective Imagery Test
Measured: Baseline, Post-intervention (2 weeks post-baseline)
Scrambled Sentences Test (SST)
Measured: Baseline, Post-intervention (2 weeks post-baseline)
Implicit Associations Test (IAT)
Measured: Baseline, Post-intervention (2 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Blackwell, Ruhr University of Bochum
- Investigators
- Simon E Blackwell, DClinPsych, Principal investigator, Ruhr University of BochumJürgen Margraf, PhD, Study chair, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958228
- Sponsor's protocol ID
- 325
- Status last verified
- Mar 2018
- First submitted
- 4 Nov 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 30123524
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings
- ClinicalTrials.gov ID
- NCT02958228
- Acronym / sponsor ID
- 325
- Conditions
- Depression, Anxiety, Anhedonia
- Keywords
- Positive Affect, Mental Imagery, Cognitive Bias Modification, Cognitive Control Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Mental Imagery Training (PMIT) | Experimental | Behavioral: Positive Mental Imagery Training (PMIT), Other: Treatment as UsualComputerized 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. |
| Cognitive Control Training (CCT) | Active comparator | Behavioral: Cognitive Control Training (CCT), Other: Treatment as UsualAn 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. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Mental Imagery Training (PMIT) | Behavioural | Positive Mental Imagery Training (PMIT) |
| Cognitive Control Training (CCT) | Behavioural | Cognitive Control Training (CCT) |
| Treatment as Usual | Other | Cognitive Control Training (CCT), Positive Mental Imagery Training (PMIT), Treatment as Usual |
Primary outcome
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'.
8 secondary outcomes
21-item positive subscale from the extended Positive and Negative Affect Schedules
Time frame: Baseline, Follow-up (2 weeks after the post-intervention assessment)
Dimensional Anhedonia Rating Scale
Time frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
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)
GAD-7
Time frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Positive Mental Health Scale
Time frame: Baseline, Post-intervention (2 weeks post-baseline), Follow-up (2 weeks after the post-intervention assessment)
Prospective Imagery Test
Time frame: Baseline, Post-intervention (2 weeks post-baseline)
Scrambled Sentences Test (SST)
Time frame: Baseline, Post-intervention (2 weeks post-baseline)
Implicit Associations Test (IAT)
Time frame: Baseline, Post-intervention (2 weeks post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 30123524Blackwell 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon E Blackwell, DClinPsych principal investigator
Ruhr University of Bochum
Jürgen Margraf, PhD study chair
Ruhr University of Bochum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Mental Imagery Training (PMIT) and Treatment as Usual in people with Depression and Anxiety, run by Ruhr University of Bochum at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
21-item positive subscale from the extended Positive and Negative Affect Schedules (time frame: Post-intervention (2 weeks post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02958228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.