Dataset Information

Personalized ESM monitoring and feedback to support psychological treatment for depression: a pragmatic randomized controlled trial (Therap-i).

ABSTRACT:

Background

Major depressive disorder (MDD) is a highly prevalent mental disorder with large disease burden, high levels of relapse or persistence, and overall suboptimal outcomes of protocolized pharmacological and psychotherapeutic treatments. There is an urgent need to improve treatment effectiveness, possibly through systematic treatment personalization. In psychotherapeutic treatments this can be achieved by case conceptualization. To support this process, we developed the Therap-i module, which consists of personalized Experienced Sampling Methodology (ESM) and feedback. The Therap-i module is integrated into outpatient psychotherapeutic treatment as usual (TAU) for depression. The study aim is to investigate the efficacy of the Therap-i module in decreasing symptomatology in unresponsive or relapsing patients diagnosed with MDD. We hypothesize that the Therap-i module will contribute to TAU by i) decreasing depressive symptoms, and ii) improving general functioning, therapeutic working alliance, and illness perception. This paper provides details of the study rationale, aims, procedures, and a discussion on potential pitfalls and promises of the module.

Methods

Patients diagnosed with MDD (n?=?100) will enrol in a pragmatic two-armed randomized controlled trial. Randomization is stratified according to the patient's treatment resistance level assessed with the Dutch Method for quantification of Treatment Resistance in Depression (DM-TRD). All fill-out the Inventory of Depressive Symptomatology Self Report (IDS-SR), Outcome Questionnaire (OQ-45), Illness Perception Questionnaire Mental Health (IPQ-MH), and Work Alliance Inventory Self Report (WAI-SR). In the intervention arm, through close collaboration between patient, clinician, and researcher, a personalized ESM diary is developed based on the patient's case conceptualization. During the ESM monitoring period (8?weeks, 5 assessments/day), patients receive feedback three times, which is discussed among the abovementioned three parties. Both patients and clinicians will evaluate the Therap-i module.

Results

Data collection is ongoing.

Discussion

This is the first study in which personalized ESM and feedback is integrated in outpatient psychotherapeutic TAU for depression. The labour intensive procedure and methodological pitfalls are anticipated challenges and were taken into account when designing the study. When hypotheses are confirmed, the Therap-i module may advance treatment for depression by providing insights into personalized patterns driving or perpetuating depressive complaints.

Trial registration

Trial NL7190 (NTR7381) , registered prospectively 03-08-2018.

SUBMITTER: Riese H

PROVIDER: S-EPMC7945664 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Personalized ESM monitoring and feedback to support psychological treatment for depression: a pragmatic randomized controlled trial (Therap-i).

Riese H H von Klipstein L L Schoevers R A RA van der Veen D C DC Servaas M N MN

BMC psychiatry 20210310 1

<h4>Background</h4>Major depressive disorder (MDD) is a highly prevalent mental disorder with large disease burden, high levels of relapse or persistence, and overall suboptimal outcomes of protocolized pharmacological and psychotherapeutic treatments. There is an urgent need to improve treatment effectiveness, possibly through systematic treatment personalization. In psychotherapeutic treatments this can be achieved by case conceptualization. To support this process, we developed the Therap-i m ...[more]

PMID: 33691647

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Project description:BackgroundDepression is a leading cause of disability worldwide. To reduce the societal burden and improve quality of life for individual patients, treatments for depression need to be optimized. There is a particular need for person-tailored interventions that reinforce self-management of patients. Systematic self-monitoring and personalized feedback through the Experience Sampling Method (ESM) could provide such a person-tailored, empowering intervention that enhances treatment outcomes. The primary aim of this study is to investigate the efficacy of self-monitoring and personalized feedback as an add-on tool in the treatment of depressive complaints in a natural setting.MethodsThe ZELF-i study is a pragmatic multi-site randomized controlled trial (RCT). We aim to recruit 150 individuals with depressive symptoms aged between 18 and 65 years, who have an intake for outpatient basic or specialized treatment at a mental health care organization in the North of the Netherlands. After the intake, participants will be randomly allocated to one of three study arms: two experimental groups engaging in 28 days of systematic self-monitoring (5 times per day) and receiving weekly personalized feedback on positive affect and activities ("Do"-module) or on negative affect and thinking patterns ("Think"-module), and a control group receiving no additional intervention. Self-report inventories of depressive symptoms, psychosocial functioning and feelings of empowerment will be administered before and after the intervention period, and at follow-up measurements at 1, 2, 3 and 6 months. The patient-experienced utility of the intervention will be investigated by a combination of quantitative and qualitative research methods.DiscussionThe present study is the first to examine the effects of add-on self-monitoring and personalized feedback on depressive complaints in clinical practice. It is also the first to evaluate two different ESM modules targeted at both of depression's core symptoms. Lastly, it is the first study that uses a combination of qualitative and quantitative methods to evaluate the patient-experienced utility of ESM with personalized feedback as an intervention for depression. Results of the present study may improve treatment for depression, if the intervention is found to be effective.Trial registrationDutch Trial Register, NTR5707 , registered prospectively 1 February 2016.

Project description:Personalized feedback is a promising self-help for problem gamblers. Such interventions have shown consistently positive results with other addictive behaviours, and our own pilot test of personalized normative feedback materials for gamblers yielded positive findings. The current randomized controlled trial evaluated the effectiveness, and the sustained efficacy, of the personalized feedback intervention materials for problem gamblers.Respondents recruited by a general population telephone screener of Ontario adults included gamblers with moderate and severe gambling problems. Those who agreed to participate were randomly assigned to receive: 1) the full personalized normative feedback intervention; 2) a partial feedback that contained all the feedback information provided to those in condition 1 but without the normative feedback content (i.e., no comparisons provided to general population gambling norms); or 3) a waiting list control condition. The primary hypothesis was that problem gamblers who received the personalized normative feedback intervention would reduce their gambling more than problem gamblers who did not receive any intervention (waiting list control condition) by the six-month follow-up.The study found no evidence for the impact of normative personalized feedback. However, participants who received, the partial feedback (without norms) reduced the number of days they gambled compared to participants who did not receive the intervention. We concluded that personalized feedback interventions were well received and the materials may be helpful at reducing gambling. Realistically, it can be expected that the personalized feedback intervention may have a limited, short term impact on the severity of participants' problem gambling because the intervention is just a brief screener. An Internet-based version of the personalized feedback intervention tool, however, may offer an easy to access and non-threatening portal that can be used to motivate participants to seek further help online or in person.ClinicalTrials.govNCT00578357.

Project description:BACKGROUND:Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. OBJECTIVE:To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). METHODS:A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). RESULTS:In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. CONCLUSIONS:Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. TRIAL REGISTRATION:German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9).

Project description:ObjectivesHeart Failure is a chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms. The objective of the study is to compare the effects of two evidence-based treatment options for adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health related quality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality at 3, 6 and 12-months.MethodsTrial design. Pragmatic, randomized, comparative effectiveness trial. Interventions. The treatment interventions are: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS). Participants. Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA) Class II, III, and IV) and depression (defined as a score of 10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data. Thus, we plan to include 150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed.ConclusionsThe current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure. The trial will provide novel results that will be disseminated and implemented into a wide range of current practice settings.RegistrationClinicalTrials.Gov Identifier: NCT03688100.

Dataset Information

Personalized ESM monitoring and feedback to support psychological treatment for depression: a pragmatic randomized controlled trial (Therap-i).

Background

Methods

Results

Discussion

Trial registration

Publications

Personalized ESM monitoring and feedback to support psychological treatment for depression: a pragmatic randomized controlled trial (Therap-i).

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