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

Trials ◽  
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.

Evaluating Culturally Responsive Group Work with Black Women

2011 ◽  
Vol 21 (6) ◽  
pp. 737-746 ◽  
Author(s):  
Lani V. Jones ◽  
Lynn A. Warner
Keyword(s):  
Depressive Symptoms ◽  
Black Women ◽  
Perceived Stress ◽  
Group Intervention ◽  
Intervention Program ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Psychosocial Competence

Purpose: This study examined the efficacy of a culturally congruent group treatment model, entitled “Claiming Your Connections” (CYC) aimed at reducing depressive symptoms and perceived stress, and enhancing psychosocial competence (i.e., locus of control and active coping) among Black women. Method: A total of 58 Black women recruited from health and human service community-based organizations were randomly assigned to either the CYC intervention or a wait-list control group. Women in the CYC program attended weekly group intervention sessions over a 10-week period, and the wait-list control group did not receive any treatment for the same duration. Results: At pretreatment both groups indicated moderate levels of depressive symptoms, perceived stress, and psychosocial competence. After the intervention, the CYC group reported a significant reduction in depressive symptoms and perceived stress. There was no statistically significant change on these variables for the control group. Implications: Results suggest that the CYC group intervention program is effective with Black women who report having difficulty managing stressors of daily life.

scholarly journals The self-esteem booster: A randomized controlled trial investigating a mobile-based intervention in students with depressive symptoms (Preprint)

2020 ◽  
Author(s):  
Alina Bruhns ◽  
Thies Lüdtke ◽  
Steffen Moritz ◽  
Lara Bücker
Keyword(s):  
Depressive Symptoms ◽  
Intervention Group ◽  
Self Esteem ◽  
The Self ◽  
Smartphone App ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Self Help

BACKGROUND Depressive symptoms are one of the most common and ever increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need for help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap. OBJECTIVE In the framework of a randomized controlled trial, we investigated the effectiveness, acceptance and side effects of a self-help smartphone app (MCT & More) based on techniques of cognitive behavioral therapy (CBT), mindfulness, acceptance and commitment therapy, and metacognitive training (MCT) in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes towards internet- and mobile-based interventions on treatment adherence and effectiveness. METHODS A total of 400 students were recruited via open access websites and randomized to either the intervention group (n = 200), who received access to the self-help smartphone app "MCT & More" for a period of four weeks, or to a wait list control group (n = 200). The PHQ-9 (depression) served as primary outcome parameter, the RSE (self-esteem) and the global item of the WHOQOL-BREF (quality of life) as secondary outcome parameters. The APOI was used to measure attitudes towards internet- and mobile-based interventions. Outcome expectations were assessed with the PATHEV and side effects with the INEP. RESULTS Per-protocol (PP), complete-case (CC) and intention-to-treat (ITT) analyses showed a significantly higher reduction in depressive symptoms (PP: F(1,222) = 3.98, P = .047, d = .26) and a significantly higher increase in self-esteem (PP: F(1,220) = 8.79, P = .003, d = .77) within the intervention group compared to the wait list control group. Most participants used the self-help smartphone app regularly (76 % at least once a week). The more positive the attitude towards internet- and mobile-based interventions (r = .260, P = .004) and the more positive the outcome expectation (r = .236, P = .009), the more frequently the self-help smartphone app was used. CONCLUSIONS The effectiveness of the self-help smartphone app "MCT & More" was demonstrated among students with depressive symptoms compared to a wait list control group. The app could be offered regularly as a low-threshold intervention to enhance students' health. CLINICALTRIAL German Clinical trials Register (DRKS00020941); https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020941

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

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.

Combined Memory Training: An Approach for Episodic Memory Deficits in Traumatic Brain Injury

2021 ◽  
Vol 30 (2S) ◽  
pp. 920-932
Author(s):  
Elisabeth Cochran D'Angelo ◽  
Beth A. Ober ◽  
Gregory K. Shenaut
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Treatment Group ◽  
Episodic Memory ◽  
Semantic Memory ◽  
Memory Deficits ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control

Purpose The study aimed to test a combination of semantic memory and traditional episodic memory therapies on episodic memory deficits in adults with traumatic brain injury. Method Twenty-five participants who had been diagnosed with traumatic brain injury and had episodic memory deficits were randomly assigned either to a combined memory treatment group ( n = 16) or to a wait-list control group ( n = 9). Before and after treatment, they completed standardized neuropsychological testing for episodic memory and related cognitive domains, including the California Verbal Learning Test–Second Edition, the Controlled Oral Word Association Test, the University of Southern California Repeatable Episodic Memory Test, the Wechsler Abbreviated Scale of Intelligence–Second Edition Matrices, the Test of Everyday Attention, the Memory Assessment Clinics Self-Rating Scale, the Expressive Vocabulary Test–Second Edition, and the Story Recall subtest from the Rivermead Behavioural Memory Test. In addition to a traditional episodic memory therapy, the treatment group received a novel semantic memory–focused therapy, which involved participants finding meaningful connections between diverse concepts represented by sets of two or three words. Results The treatment group demonstrated statistically significant improvement in memory for list learning tasks, and there was a significant difference from pretest to posttest between the treatment group and the wait-list control group. Clinical significance was demonstrated for the treatment group using minimally important difference calculations. Conclusion Combined memory therapy resulted in significant improvements in episodic memory, semantic memory, and attention, in comparison to no treatment. Supplemental Material https://doi.org/10.23641/asha.14049968

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

2011 ◽  
Vol 17 (9) ◽  
pp. 1130-1140 ◽  
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.

scholarly journals The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial

SLEEP ◽  
2020 ◽  
Vol 43 (9) ◽  
Author(s):  
Simon D Kyle ◽  
Madeleine E D Hurry ◽  
Richard Emsley ◽  
Antonia Marsden ◽  
Ximena Omlin ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Cognitive Behavioral Therapy ◽  
Cognitive Performance ◽  
Behavioral Therapy ◽  
Wait List ◽  
Depression And Anxiety ◽  
Wait List Control ◽  
Cognitive Failures ◽  
The Impact ◽  
Insomnia Severity

Abstract Study Objectives We sought to examine the impact of digital cognitive behavioral therapy (dCBT) for insomnia on both self-reported cognitive impairment and objective cognitive performance. Methods The Defining the Impact of Sleep improvement on Cognitive Outcomes (DISCO) trial was an online, two-arm, single-blind, randomized clinical trial of dCBT versus wait-list control. Participants were aged 25 years and older, met DSM-5 diagnostic criteria for insomnia disorder, and reported difficulties with concentration or memory. Assessments were carried out online at baseline, and 10 and 24 weeks post-randomization. The primary outcome measure was self-reported cognitive impairment, assessed with the British Columbia Cognitive Complaints Inventory (BC-CCI). Secondary outcomes included tests of cognitive performance, insomnia symptoms, cognitive failures, fatigue, sleepiness, depression, and anxiety. Results Four hundred and ten participants with insomnia were recruited and assigned to dCBT (N = 205) or wait-list control (N = 205). At 10 weeks post-randomization the estimated adjusted mean difference for the BC-CCI was −3.03 (95% CI: −3.60, −2.47; p < 0.0001, d = −0.86), indicating that participants in the dCBT group reported less cognitive impairment than the control group. These effects were maintained at 24 weeks (d = −0.96) and were mediated, in part, via reductions in insomnia severity and increased sleep efficiency. Treatment effects in favor of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety. We found no between-group differences in objective tests of cognitive performance. Conclusions Our study shows that dCBT robustly decreases self-reported cognitive impairment at post-treatment and these effects are maintained at 6 months.

Comparison of Two Group Interventions to Promote Forgiveness: Empathy as a Mediator of Change

2010 ◽  
Vol 32 (1) ◽  
pp. 35-57 ◽  
Author(s):  
Steven Sandage ◽  
Everett Worthington
Keyword(s):  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Care Giving ◽  
Behavioral System ◽  
Shame Proneness ◽  
Post Test ◽  
Student Volunteers

Undergraduate student volunteers (N=97) were randomly assigned to one of two six-hour forgiveness psychoeducational seminars or to a wait-list control group. Based on attachment theory, forgiveness was conceptualized in relation to the care-giving behavioral system (Mikulincer & Shaver, 2007). Both the Empathy Forgiveness Seminar and the Self-enhancement Forgiveness Seminar facilitated forgiveness to a greater degree than the wait-list control group at post-test and six-week follow-up. Empathy mediated changes in participants' forgiveness scores regardless of seminar condition. Shame-proneness was negatively related to post-test forgiveness scores and guilt-proneness was positively related to forgiveness at post-test and follow-up. Implications for interventions are discussed.

scholarly journals Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Jian Li ◽  
Natalie Riedel ◽  
Amira Barrech ◽  
Raphael M. Herr ◽  
Birgit Aust ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Stress Management ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
External Control ◽  
Control Group ◽  
Wait List ◽  
Eri Model

Objective. Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. Methods. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group (n=94). Results. Effort and reward were substantially improved with significant intervention ⁎ time interaction effects (p<0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant (p<0.05 and p<0.01, resp.), though their trajectories in the intervention group were less sustainable. Conclusions. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

scholarly journals A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Bettina Wollesen ◽  
Madeleine Fricke ◽  
Carl-Philipp Jansen ◽  
Katharina Gordt ◽  
Michael Schwenk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Spatial Orientation ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Abstract Background In nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents. Methods A three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated. Discussion This study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations. Trial registration The trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217).

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