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

2019 ◽  
Vol 17 (1) ◽  
pp. 21-28 ◽  
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.

scholarly journals Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0244717
Author(s):  
Jennifer L. Huberty ◽  
Jeni Green ◽  
Megan E. Puzia ◽  
Linda Larkey ◽  
Breanne Laird ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Daytime Sleepiness ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Sleep Arousal

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

scholarly journals A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jolie N Haun ◽  
Lisa M Ballistrea ◽  
Christine Melillo ◽  
Maisha Standifer ◽  
Kevin Kip ◽  
...  
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Integrative Health ◽  
Randomized Controlled

BACKGROUND Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. OBJECTIVE This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). METHODS This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. RESULTS Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. CONCLUSIONS This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. CLINICALTRIAL ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/13666

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).

The advanced cancer patient experience of undertaking meaning and purpose (MaP) therapy

2012 ◽  
Vol 10 (3) ◽  
pp. 177-188 ◽  
Author(s):  
Carrie Lethborg ◽  
Penelope Schofield ◽  
David Kissane
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Potential Effect ◽  
Effect Sizes ◽  
Convenience Sample ◽  
Therapeutic Goals ◽  
Randomized Controlled ◽  
Meaning And Purpose ◽  
Therapeutic Frame ◽  
Therapy Sessions

AbstractObjective:The objective of this study was to describe the experience of undertaking meaning and purpose (MaP) therapy for patients with advanced cancer, with an aim of refining therapeutic processes involved prior to pilot testing. Specifically, we were interested in examining the themes arising from participation in the intervention in relation to our therapeutic goals, and how acceptable both the number of sessions and processes used were.Method:A convenience sample of people living with advanced cancer was recruited to participate in this process, resulting in 24 therapy sessions for analysis.Results:A thematic analysis of each session illustrated that the process of MaP therapy is one that encourages reflection, offers insights, and can be confrontational, but can also allow participants to “shift” their perspective and focus onto meaningful goals. Results illustrate how the therapist creates a therapeutic frame that holds up a poignant portrayal of the meaning of life lived, and mirrors this to the patient, such that they grasp its rich texture. Participants' descriptions showed how they were buoyed forward as a result, with renewed vigor and enthusiasm, despite their illness and any physical restrictions that it imposed.Significance of results:A planned pilot test of this intervention will enable us to determine potential effect sizes of this therapy in reducing distress and increasing meaning prior to a full randomized controlled trial. Understanding the processes involved and the experiences of participation in meaning-based therapies is crucial to the future strength of this area of psychotherapy.

scholarly journals The Effectiveness of an Integrated Treatment for Functional Speech Sound Disorders—A Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (12) ◽  
pp. 1190
Author(s):  
Denise I. Siemons-Lühring ◽  
Harald A. Euler ◽  
Philipp Mathmann ◽  
Boris Suchan ◽  
Katrin Neumann
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Speech Sound ◽  
Control Group ◽  
Wait List ◽  
Speech Sound Disorders ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Background: The treatment of functional speech sound disorders (SSDs) in children is often lengthy, ill-defined, and without satisfactory evidence of success; effectiveness studies on SSDs are rare. This randomized controlled trial evaluates the effectiveness of the integrated SSD treatment program PhonoSens, which focuses on integrating phonological and phonetic processing according to the Integrated Psycholinguistic Model of Speech Processing (IPMSP). Methods: Thirty-two German-speaking children aged from 3.5 to 5.5 years (median 4.6) with functional SSD were randomly assigned to a treatment or a wait-list control group with 16 children each. All children in the treatment group and, after an average waiting period of 6 months, 12 children in the control group underwent PhonoSens treatment. Results: The treatment group showed more percent correct consonants (PCC) and a greater reduction in phonological processes after 15 therapy sessions than the wait-list control group, both with large effect sizes (Cohen’s d = 0.89 and 1.04). All 28 children treated achieved normal phonological abilities: 21 before entering school and 7 during first grade. The average number of treatment sessions was 28; the average treatment duration was 11.5 months. Conclusion: IPMSP-aligned therapy is effective in the treatment of SSD and is well adaptable for languages other than German.

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