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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.

ABSTRACT: Background:Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training paradigm involving generation of positive mental imagery can increase state positive affect, and more recent clinical studies have suggested that this training could be used as an adjunct treatment module to target symptoms related to positive affect deficits, specifically anhedonia. The current study investigates the feasibility of adding a positive mental imagery computerized training module to treatment for patients in inpatient mental health settings, with a focus on increasing positive affect and reducing anhedonia. The positive mental imagery training (PMIT) is added to treatment as usual (TAU) in the inpatient setting, and compared to TAU alone, or TAU plus an alternative cognitive training module not hypothesized to increase positive affect, cognitive control training (CCT). Methods:The study is a feasibility randomized controlled trial with three parallel arms. Up to 90 patients admitted to inpatient mental health treatment clinics in Germany will be randomized to PMIT?+?TAU, CCT?+?TAU, or TAU on a 1:1:1 ratio. PMIT or CCT consist of an introductory session followed by up to 8 full training sessions over 2 weeks. All three arms (including TAU) include regular completion of mood measures over the 2-week period. Outcome measures are completed pre and post this 2-week training/monitoring period, and at 2-week follow-up. Data will be presented in the form of both raw means and standardized effect sizes, with 95% confidence intervals, for both intention-to-treat and per-protocol samples. Discussion:The study will inform feasibility of conducting a fully powered randomized controlled trial investigating the addition of the positive mental imagery training as a treatment adjunct to inpatient treatments for mental health, including potential refinement of study procedures, inclusion/exclusion criteria, and preliminary indications of the likely range of effect sizes. Trial registration:clinicaltrials.gov, NCT02958228 (date registered: 4 November 2016).

SUBMITTER: Blackwell SE

PROVIDER: S-EPMC6091085 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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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.

Blackwell Simon E SE Westermann Katharina K Woud Marcella L ML Cwik Jan C JC Neher Torsten T Graz Christian C Nyhuis Peter W PW Margraf Jürgen J

Pilot and feasibility studies 20180804

<h4>Background</h4>Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training paradigm involving generation of positive mental imagery can increase state positive affect, and more recent clinical studies have suggested that this training could be used as an adjunct treatment module to target symptoms related to positive affect deficits, specifical ...[more]

PMID: 30123524

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Project description:BackgroundMost people affected by depression or anxiety disorders are treated solely by their primary care physician. Access to specialized mental health care is impeded by patients' comorbidity and immobility in aging societies and long waiting times at the providers' end. Video-based integrated care models may leverage limited resources more efficiently and provide timely specialized care in primary care settings.ObjectiveThe study aims to evaluate the feasibility of mental health specialist video consultations with primary care patients with depression or anxiety disorders.MethodsParticipants were recruited by their primary care physicians during regular practice visits. Patients who had experienced at least moderate symptoms of depression and/or anxiety disorders were considered eligible for the study. Patients were randomized into 2 groups receiving either treatment-as-usual as provided by their general practitioner or up to 5 video consultations conducted by a mental health specialist. Video consultations focused on systematic diagnosis and proactive monitoring using validated clinical rating scales, the establishment of an effective working alliance, and a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. Feasibility outcomes were recruitment, rate of loss to follow-up, acceptability of treatment, and attendance at sessions. Effectiveness outcomes included depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), burden of specific somatic complaints (Somatic Symptom Disorder-B Criteria Scale-12), recovery (Recovery Assessment Scale-German [RAS-G]), and perception of chronic illness care (Patient Assessment of Chronic Illness Care), which were measured at baseline and 16 weeks postallocation by assessors blinded to the group allocation.ResultsA total of 50 patients with depression and/or anxiety disorders were randomized, 23 in the intervention group and 27 in the treatment-as-usual group. The recruitment yield (number randomized per number screened) and the consent rate (number randomized per number eligible) were 69% (50/73) and 86% (50/58), respectively. Regarding acceptability, 87% (20/23) of the participants in the intervention group completed the intervention. Of the 108 planned video consultations, 102 (94.4%) were delivered. Follow-up rates were 96% (22/23) and 85% (23/27) for the intervention and control groups, respectively. The change from baseline scores at postmeasurement for the No Domination by Symptoms domain of recovery (RAS-G) was somewhat higher in the intervention group than in the control group (Mann-Whitney U test: rank-biserial r=0.19; 95% CI -0.09 to 0.46; P=.18). We did not detect any notable differences between the intervention and control groups in terms of other effectiveness outcomes. We did not observe any serious adverse events related to the trial.ConclusionsThe intervention and study procedures were found to be feasible for patients, primary care practice staff, and mental health specialists. A sufficiently powered pragmatic trial on mental health specialist video consultations should be conducted to investigate their effectiveness in routine care.Trial registrationGerman Clinical Trials Register DRKS00015812; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015812.

Project description:ObjectiveThis study aimed to assess the feasibility of a future trial comparing the collaborative care model with usual care for patients with musculoskeletal conditions and co-existing symptoms of anxiety and depression.DesignA single-centre, parallel-arm, one-to-one, randomised controlled trial design using a mixed-methods approach was used. semistructured interviews and focus groups were conducted post intervention with all participants and staff respectively to explore acceptability towards the model and identify recommendations for improvements.SettingAn orthopaedic rehabilitation outpatient tertiary hospital.ParticipantsAdult patients with musculoskeletal conditions and co-existing moderate or severe symptoms of anxiety and depression attending outpatient therapy appointments.InterventionThe collaborative care model consisted of a tailored management programme to facilitate the integration of care provided by physical and mental healthcare professionals. A case manager screened and coordinated targeted mental health support for participants. Participants allocated to usual care had no support from the case manager.Main outcomes measureFeasibility indicators (rates of recruitment, randomisation and retention), acceptability of clinical outcome measures, usage of additional resources and cost of intervention implementation.ResultsOf the 89 patients who provided consent to take part, 40 participants who matched the eligibility criteria were randomised to either the intervention (n=20) or usual care arm (n=20). Overall adherence to the intervention was 58.82%, while the withdrawal rate was 37.5% at 6 months. All of the 27 participants who were retained completed self-reported outcomes. Qualitative data highlighted that integrated mental health support was favourably perceived. In addition to prenegotiating protected psychology time, the need for operationalised communication between the case manager and clinicians was identified as a recommendation for a future trial.ConclusionsThe trial and intervention were acceptable to patients and healthcare professionals. While the findings demonstrate the feasibility of trial recruitment, a future trial will require optimised retention strategies to improve adherence and withdrawal rates.Trial registration numberNCT05018039.

Dataset Information

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.

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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.

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