Internet-based treatment for depression in multiple sclerosis: A randomized controlled trial

Background: Depression in multiple sclerosis (MS) patients is common but may stay untreated. Physical limitations impede face-to-face treatment. Internet-based treatment is therefore a promising tool for treating depression in MS. Objectives: To investigate effectiveness of a guided Internet-based problem-solving treatment (IPST) for depressed MS patients. Methods: MS patients with moderate or severe depressive symptoms were randomly assigned to IPST or a wait list control. Primary outcome was the change in depressive symptoms defined by a change in sum score on the Beck Depression Inventory Second Edition (BDI-II). Assessments took place at baseline (T0), within a week after the intervention (T1), and at 4 months follow-up (T2). Analyses were based on the intention-to-treat principle. Results: A total of 171 patients were randomized to IPST ( n = 85) or a wait list control ( n = 86). T1 was completed by 152 (89%) and T2 by 131 patients (77%). The IPST group and wait list control showed large significant improvements in depressive symptoms, but no differences were found between groups at T1 ( d = 0.23; 95% confidence interval (CI) = (−4.03, 1.08); p = 0.259) and T2 ( d = 0.01; 95% CI = (−2.80, 2.98); p = 0.953). Conclusion: We found no indication that IPST for MS patients with moderate or severe depression is effective in reducing depressive symptoms compared to a waiting list. Large improvements in the wait list control were unexpected and are discussed.

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A Protocol for Measuring the Direct Psychological Benefit of Neuropsychological Assessment with Feedback in Multiple Sclerosis

Brain Impairment ◽

10.1017/brimp.2012.20 ◽

2012 ◽

Vol 13 (2) ◽

pp. 238-255 ◽

Cited By ~ 1

Author(s):

Wendy A. Longley ◽

Robyn L. Tate ◽

Rhonda F. Brown

Keyword(s):

Multiple Sclerosis ◽

Neuropsychological Assessment ◽

Control Method ◽

Research Effort ◽

Controlled Trial ◽

Wait List ◽

Wait List Control ◽

Positive Caregiving ◽

Randomised Controlled ◽

Cognitive Strengths

This article reports on the design of a two-arm, randomised controlled trial of neuropsychological assessment with feedback as a direct therapeutic intervention to improve psychological wellbeing in multiple sclerosis (MS). MS patients and their caregivers are randomly allocated to one of two groups: neuropsychological assessment with feedback (the intervention), or ‘sham wait-list’ control. The trial investigates: (1) whether the intervention directly benefits patients by leading to improved knowledge of their own specific cognitive strengths and weaknesses, and improved use of adaptive psychological strategies for coping with MS; and (2) whether the intervention directly benefits caregivers by leading to improved knowledge of the patients’ specific cognitive strengths and weaknesses, and to a more positive caregiving outcome. A range of primary and secondary measures is used to evaluate these outcomes. The protocol utilises a wait-list control method which is structured to effectively blind patients and caregivers to their group allocation. Publishing the protocol prior to the results of the trial being available has a number of important methodological benefits, and informs the research community of the work that is under way to allow for collaboration and to reduce duplication of research effort. (This trial has been registered on the ANZCTR; ACTRN12612000161820.)

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DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Journal of Child Health Care ◽

10.1177/13674935211003774 ◽

2021 ◽

pp. 136749352110037

Author(s):

Alison E. Parker ◽

Tracy M. Scull ◽

Abigail M. Morrison

Keyword(s):

Clinical Trials ◽

Interactive Multimedia ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Wait List ◽

Wait List Control Group ◽

Wait List Control ◽

Satisfaction Questionnaire ◽

Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

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Randomized trial of a teleconference-delivered fatigue management program for people with multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458511404272 ◽

2011 ◽

Vol 17 (9) ◽

pp. 1130-1140 ◽

Cited By ~ 76

Author(s):

Marcia Finlayson ◽

Katharine Preissner ◽

Chi Cho ◽

Matthew Plow

Keyword(s):

Multiple Sclerosis ◽

Management Education ◽

Management Program ◽

Secondary Outcome ◽

Control Group ◽

Wait List ◽

Impact Fatigue ◽

Wait List Control ◽

Fatigue Management ◽

Fatigue Severity

Background: Previous studies support the efficacy and effectiveness of face-to-face group-based fatigue management education for people with multiple sclerosis (MS). Nevertheless, many people are unable to access these programs due to environmental barriers. Objectives: To test the efficacy and effectiveness of a group-based, teleconference-delivered fatigue management program for people with MS. Methods: A randomly allocated two-group time series design with a wait-list control group was used. In total 190 participants were allocated (94 intervention, 96 wait-list control). Primary outcomes (fatigue impact, fatigue severity, health-related quality of life (HRQOL)) were measured before, immediately after, at 6 weeks, 3 months, and 6 months post. Secondary outcome (self-efficacy) was measured at the same points. Effectiveness (intent-to-treat) and efficacy (per protocol) analyses were conducted. Results: The program was more effective and efficacious than control for reducing fatigue impact but not fatigue severity. Before and after comparisons with the pooled sample demonstrated efficacy and effectiveness for fatigue impact, fatigue severity, and 6 of 8 HRQOL dimensions. Changes were maintained for 6 months with small to moderate effect sizes. Conclusion: The results offer strong support for the viability of teleconference-delivered fatigue management education for enabling people with MS to manage this disabling symptom.

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Metta-based group meditation and individual cognitive behavioral therapy (MeCBT) for chronic depression: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3815-4 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Artjom Frick ◽

Isabel Thinnes ◽

Ulrich Stangier

Keyword(s):

Depressive Symptoms ◽

Cognitive Behavioral Therapy ◽

Positive Affect ◽

Behavioral Therapy ◽

Chronic Depression ◽

Secondary Outcome ◽

Control Group ◽

Wait List ◽

Wait List Control Group ◽

Wait List Control

Abstract Background Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing negative affect and have paid little attention to promoting positive affect. Previous studies have shown that metta meditation increases positive affect in chronically depressed patients. Results from previous trials provide evidence for the efficacy of a stand-alone metta meditation group treatment in combination with mindfulness-based approaches. Further research is needed to better understand the implementation of meditation practice into everyday life. Therefore, mindfulness and metta meditation in a group setting are combined with individual cognitive behavioral therapy (CBT) into a new, low-intensity, cost-effective treatment (“MeCBT”) for chronic depression. Methods/design In this single-center, randomized, observer-blinded, parallel-group clinical trial we will test the efficacy of MeCBT in reducing depression compared to a wait-list control condition. Forty-eight participants in a balanced design will be allocated randomly to a treatment group or a wait-list control group. Metta-based group meditation will be offered in eight weekly sessions and one additional half-day retreat. Subsequent individual CBT will be conducted in eight fortnightly sessions. Outcome measures will be assessed at four time points: before intervention (T0); after group meditation (T1); after individual CBT (T2); and, in the treated group only, at 6-month follow-up (T3). Changes in depressive symptoms (clinician rating), assessed with the Quick Inventory of Depressive Symptoms (QIDS-C) are the primary outcome. We expect a significant decline of depressive symptoms at T2 compared to the wait-list control group. Secondary outcome measures include self-rated depression, mindfulness, benevolence, rumination, emotion regulation, social connectedness, social functioning, as well as behavioral and cognitive avoidance. We will explore changes at T1 and T2 in all these secondary outcome variables. Discussion To our knowledge this is the first study to combine a group program focusing on Metta meditation with state-of-the art individual CBT specifically tailored to chronic depression. Implications for further refinement and examination of the treatment program are discussed. Trial registration ISRCTN, ISRCTN97264476. Registered 29 March 2018 (applied on 14 December 2017)—retrospectively registered.

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Evaluation of the efficacy of email-delivered vs face-to-face group cognitive behavioral therapy for insomnia in youths: a randomized wait-list controlled trial

Sleep Medicine ◽

10.1016/j.sleep.2019.11.166 ◽

2019 ◽

Vol 64 ◽

pp. S60-S61

Author(s):

N.Y. Chan ◽

S.P. Lam ◽

J. Zhang ◽

M.W.M. Yu ◽

S. Suh ◽

...

Keyword(s):

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cognitive Behavioral ◽

Wait List ◽

Face To Face

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Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial

Multiple Sclerosis Journal ◽

10.1177/1352458517702751 ◽

2017 ◽

Vol 23 (11) ◽

pp. 1527-1541 ◽

Cited By ~ 18

Author(s):

Lyan JM Blikman ◽

Jetty van Meeteren ◽

Jos WR Twisk ◽

Fred AJ de Laat ◽

Vincent de Groot ◽

...

Keyword(s):

Multiple Sclerosis ◽

Energy Conservation ◽

Social Relations ◽

Conservation Management ◽

Controlled Trial ◽

Outpatient Rehabilitation ◽

Control Group ◽

Intention To Treat ◽

Unfavourable Effect ◽

The Individual

Background: Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). Objective: To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. Methods: A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength – CIS20r) and participation (Impact on Participation and Autonomy scale – IPA). Results: Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = −0.81; 95% confidence interval (CI), −3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). Conclusion: The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

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Meaning and Purpose (MaP) therapy II: Feasibility and acceptability from a pilot study in advanced cancer

Palliative & Supportive Care ◽

10.1017/s1478951518000883 ◽

2019 ◽

Vol 17 (1) ◽

pp. 21-28 ◽

Cited By ~ 2

Author(s):

David W. Kissane ◽

Carrie Lethborg ◽

Joanne Brooker ◽

Courtney Hempton ◽

Sue Burney ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pilot Study ◽

Posttraumatic Growth ◽

Advanced Cancer ◽

Controlled Trial ◽

Effect Sizes ◽

Wait List ◽

Wait List Control ◽

Randomized Controlled ◽

Meaning And Purpose

AbstractObjectiveMeaning and Purpose (MaP) therapy aims to enhance meaning-based coping through a life review that focuses on the value and worth of the person, key relationships, sources of fulfillment, roles, and future priorities in living life out fully. We sought to test the feasibility and acceptability of a six-session model of MaP therapy against a wait-list control cohort in a pilot study seeking effect sizes on measures of adaptation.MethodWe randomized patients with advanced cancer to MaP therapy or wait-list control, with measures administered at baseline and after 6–8 weeks. Wait-list patients could then crossover to receive therapy, with further measures collected postintervention. Adherence to the manualized model was sustained through weekly supervision and fidelity coding of recorded sessions. We used generalized estimating equations to control for baseline and any correlation of data.ResultFrom 134 eligible participants, 57 (43%) consented, and 40 of 45 (89%) offered therapy completed 6 sessions. Key barriers to consenting patients were poor health (15 refusers and 4 withdrawals) and death intervened in 6 participants. MaP therapy generated adequate effect sizes in posttraumatic growth (new possibilities, appreciation of life, and personal strength) and life attitudes (choices and goal seeking) to permit calculation of power for a formal randomized, controlled trial.Significance of resultsDelivery of this model of existentially oriented therapy is feasible and acceptable to patients. A properly powered randomized controlled trial is justified to examine the efficacy of this intervention.

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A Randomized Assessor-Blinded Wait-List-Controlled Trial to Assess the Effectiveness of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy

Integrative Cancer Therapies ◽

10.1177/1534735419836501 ◽

2019 ◽

Vol 18 ◽

pp. 153473541983650 ◽

Cited By ~ 10

Author(s):

Alexander Molassiotis ◽

Lorna K. P. Suen ◽

Hui Lin Cheng ◽

T. S. K. Mok ◽

Sara C. Y. Lee ◽

...

Keyword(s):

Quality Of Life ◽

Peripheral Neuropathy ◽

Standard Care ◽

Primary Outcome ◽

Controlled Trial ◽

Symptom Distress ◽

Gynecologic Oncology Group ◽

Wait List ◽

Wait List Control

Purpose: Chemotherapy-induced peripheral neuropathy is a complex side effect with few available treatment options. The aim of the study was to test the effectiveness of an 8-week course of acupuncture in the management of chemotherapy-induced peripheral neuropathy in cancer patients who were receiving or had received neurotoxic chemotherapy. Methods: Randomized assessor-blinded controlled trial with 2 arms; one arm received acupuncture twice weekly for 8 weeks, while the other arm was a wait-list control group receiving only standard care. Primary outcome was pain intensity and interference over the past week using the Brief Pain Inventory at the end of the intervention. Secondary outcomes included clinical assessment (CTCAE [Common Toxicity Criteria for Adverse Events] grading and Total Neuropathy Score–Clinical Version) and nerve conduction studies; and patient-reported outcome measures (Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity Quality of Life scale and Symptom Distress Scale) assessed at baseline, end of treatment (8 weeks), week 14, and week 20 from the beginning of treatment. Results: Eighty-seven patients were randomized to the experimental arm (n = 44) and to the standard care wait-list control arm (n = 43). Significant changes at 8 weeks were detected in relation to primary outcome (pain), the clinical neurological assessment, quality of life domains, and symptom distress (all P < .05). Improvements in pain interference, neurotoxicity-related symptoms, and functional aspects of quality of life were sustained in the 14-week assessment ( P < .05), as were physical and functional well-being at the 20-week assessment ( P < .05). Conclusions: Acupuncture is an effective intervention for treating chemotherapy-induced peripheral neuropathy and improving patients’ quality of life and experience with neurotoxicity-related symptoms with longer term effects evident.

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