| 1. |
- Molander, Olof, et al.
(författare)
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Internet-based cognitive behavior therapy for problem gambling in routine care : protocol for a non-randomized pilot and feasibility trial
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Background: Problem gambling and gambling disorder are major public health concerns worldwide, and awareness of associated negative consequences is rising. In parallel, treatment demand has increased, and Internet interventions offer a promising alternative for providing evidence-based treatment at scale to a low cost.Method: We developed a novel Internet-delivered cognitive behavioral treatment for gambling, based on qualitative interviews with treatment-seeking gamblers, behavioral research on gambling behavior, and the pathway model for problem gambling. This research protocol describes a non-randomized pilot and feasibility trial conducted in routine addiction care with adult treatment-seeking patients (max N = 25) with problem gambling. The primary aim is to ensure acceptability and safety, measured by satisfaction, credibility, working alliance, and possible negative effects. Secondary aims are feasibility of study procedures in terms of recruitment and measurement procedures as well as potential effectiveness measured weekly by gambling symptoms as primary outcome and gambling behavior, quality of life, symptoms of depression and anxiety, alcohol, and drug use as secondary outcomes. Potential mediators measured weekly are loss of control, verbal rules, and well-being.Discussion: This study is innovative in several respects, regarding both treatment development and implementation. The results of the study will guide a future randomized controlled trial, as well as the development of the intervention and intervention implementation within ordinary addiction care.Trial registration: Clinical trials.gov, NCT ID: NCT03946098. Registered 10 May 2019
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| 2. |
- Pile, Victoria, et al.
(författare)
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A brief early intervention for adolescent depression that targets emotional mental images and memories : protocol for a feasibility randomised controlled trial (IMAGINE trial).
- 2018
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 4
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Tidskriftsartikel (refereegranskat)abstract
- Background: Adolescent depression is common and impairing. There is an urgent need to develop early interventions to prevent depression becoming entrenched. However, current psychological interventions are difficult to access and show limited evidence of effectiveness. Schools offer a promising setting to enhance access to interventions, including reducing common barriers such as time away from education. Distressing negative mental images and a deficit in positive future images, alongside overgeneral autobiographical memories, have been implicated in depression across the lifespan, and interventions targeting them in adults have shown promise. Here, we combine techniques targeting these cognitive processes into a novel, brief psychological intervention for adolescent depression. This feasibility randomised controlled trial will test the feasibility and acceptability of delivering this imagery-based cognitive behavioural intervention in schools.Methods/design: Fifty-six adolescents (aged 16-18) with high symptoms of depression will be recruited from schools. Participants will be randomly allocated to the imagery-based cognitive behavioural intervention (ICBI) or the control intervention, non-directive supportive therapy (NDST). Data on feasibility and acceptability will be recorded throughout, including data on recruitment, retention and adherence rates as well as adverse events. In addition, symptom assessment will take place pre-intervention, post-intervention and at 3-month follow-up. Primarily, the trial aims to establish whether it is feasible and acceptable to carry out this project in a school setting. Secondary objectives include collecting data on clinical measures, including depression and anxiety, and measures of the mechanisms proposed to be targeted by the intervention. The acceptability of using technology in assessment and treatment will also be evaluated.Discussion: Feasibility, acceptability and symptom data for this brief intervention will inform whether an efficacy randomised controlled trial is warranted and aid planning of this trial. If this intervention is shown in a subsequent definitive trial to be safe, clinically effective and cost-effective, it has potential to be rolled out as an intervention and so would significantly extend the range of therapies available for adolescent depression. This psychological intervention draws on cognitive mechanism research suggesting a powerful relationship between emotion and memory and uses imagery as a cognitive target in an attempt to improve interventions for adolescent depression.Trial registration: ISRCTN85369879.
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| 3. |
- Steel, Craig, et al.
(författare)
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The IBER study : study protocol for a feasibility randomised controlled trial of Imagery Based Emotion Regulation for the treatment of anxiety in bipolar disorder.
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Background: Anxiety is highly prevalent in people diagnosed with bipolar disorder (BD), and can persist between acute episodes of mania and depression. Recent studies indicate that people with BD are prone to experiencing frequent, intrusive and emotional mental images which further fuel their levels of anxiety and mood instability. These intrusive emotional mental images represent a specific target for treatment for this disorder with the potential to reduce anxiety and improve mood stability. A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD. A feasibility trial is required in order to assess whether a full randomised controlled trial is indicated in order to evaluate this approach.Methods: The design is a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site and minimised on medication status and anxiety severity. Participants are 60 individuals diagnosed with bipolar disorder and experiencing at least a mild level of anxiety. Sites are defined by the geographical boundaries of two National Health Service (NHS) Trusts, with recruitment from NHS teams, GP surgeries and self-referral. The intervention is up to 12 sessions of Imagery Based Emotion Regulation within 16 weeks. The comparator is NHS standard care. The primary aim is to assess the feasibility of conducting a powered multi-site RCT to evaluate effectiveness. Measures of anxiety, depression, mania, mood stability and health care use will be conducted at baseline, end of treatment and at 16-week follow-up.Discussion: This is the first feasibility trial of an imagery-based intervention for the treatment of anxiety in bipolar disorder. If the trial proves feasible, a large multi-site trial will be required.Trial registration: ISRCTN16321795. Registered on October 16, 2018. 10.1186/ISRCTN16321795.
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| 4. |
- Gould, Rebecca, et al.
(författare)
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Acceptance and Commitment Therapy for people living with motor neuron disease : an uncontrolled feasibility study
- 2023
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Ingår i: Pilot and Feasibility Studies. - : Springer Nature. - 2055-5784. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- Background: Motor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distress should be managed in people living with MND (plwMND) is lacking. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy that may be particularly suitable for this population. However, to the authors' knowledge, no study to date has evaluated ACT for plwMND. Consequently, the primary aim of this uncontrolled feasibility study was to examine the feasibility and acceptability of ACT for improving the psychological health of plwMND.Methods: PlwMND aged >= 18 years were recruited from 10 UK MND Care Centres/Clinics. Participants received up to 8 one-to-one ACT sessions, developed specifically for plwMND, plus usual care. Co-primary feasibility and acceptability outcomes were uptake (>= 80% of the target sample [N = 28] recruited) and initial engagement with the intervention (>= 70% completing >= 2 sessions). Secondary outcomes included measures of quality of life, anxiety, depression, disease-related functioning, health status and psychological flexibility in plwMND and quality of life and burden in caregivers. Outcomes were assessed at baseline and 6 months.Results: Both a priori indicators of success were met: 29 plwMND (104%) were recruited and 76% (22/29) attended >= 2 sessions. Attrition at 6-months was higher than anticipated (8/29, 28%), but only two dropouts were due to lack of acceptability of the intervention. Acceptability was further supported by good satisfaction with therapy and session attendance. Data were possibly suggestive of small improvements in anxiety and psychological quality of life from baseline to 6 months in plwMND, despite a small but expected deterioration in disease-related functioning and health status.Conclusions: There was good evidence of acceptability and feasibility. Limitations included the lack of a control group and small sample size, which complicate interpretation of findings. A fully powered RCT to evaluate the clinical and cost-effectiveness of ACT for plwMND is underway.
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| 5. |
- Wall, Hakan, et al.
(författare)
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The evaluation of a brief ICBT program with therapist support for individuals with gambling problems in the context of a gambling helpline: a randomized pilot trial
- 2023
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Ingår i: Pilot and Feasibility Studies. - : BMC. - 2055-5784. ; 9:1
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Tidskriftsartikel (refereegranskat)abstract
- Background and aims Gambling helplines are a natural way of first contact for individuals with gambling problems. However, few studies have evaluated the feasibility and effectiveness of brief interventions in a gambling helpline. To reduce this knowledge gap, this study evaluated the feasibility of an online cognitive behavioral therapy (ICBT) program in the context of a gambling helpline as a first step towards a full-scale RCT. Design This is a two-group parallel randomized controlled pilot trial where the participants were randomized to either a brief four-module ICBT program (n = 22) or a control group (n = 21). Participants were followed up weekly during the intervention, post intervention, and 6 weeks upon completion of intervention. Participants A total of 43 self-identified individuals with gambling problems (scoring 3 or more on the Problem Gambling Severity Index) were recruited via the Swedish national gambling helpline, 59% females, mean age 43.7 years. Measurements Feasibility of the procedure and intervention (i.e., recruitment pace, attrition, program engagement, and satisfaction) were the primary outcomes; treatment effect (net gambling losses) was the secondary outcome. Results Approximately 2 participants per week were randomized, and retention was low, with 47% lost to follow-up at the 6-week follow-up time-point. Most participants engaged in the online modules (86%) and rated their overall satisfaction with the program as high (7.5 out of 10). Both groups decreased their weekly gambling losses at both follow-up time-points, but the between-group comparisons were inconclusive. Conclusion It is not advisable to conduct a full-scale RCT based on the results from this pilot study. Future studies in a gambling helpline should consider interventions that are more suited to be incorporated in a gambling helpline and identify ways to increase participant engagement.
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