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Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Persistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive-behavioural therapy (CBT) programme for adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD. METHODS AND ANALYSIS:We conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV. ETHICS AND DISSEMINATION:The Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere. TRIAL REGISTRATION NUMBER:NCT02937142.

SUBMITTER: Novik TS

PROVIDER: S-EPMC7170565 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial.

Nøvik Torunn Stene TS Haugan Anne-Lise Juul AJ Lydersen Stian S Thomsen Per Hove PH Young Susan S Sund Anne Mari AM

BMJ open 20200325 3

<h4>Introduction</h4>Persistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive-behavioural therapy (CBT) programme for adolescents with ADHD aged 14-18 years, who still have impairing symptoms after treatment with medication. We will study the effect of ...[more]

PMID: 32213517

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Project description:BackgroundCognitive behavioural therapy (CBT) is recommended for attention-deficit/hyperactivity-disorder (ADHD) in adolescents. However, all CBTs are not created equal, and the guidelines do not specify which CBT interventions are the most effective for this patient group. This study examines the efficacy of a group CBT without parent involvement as follow-up treatment compared to no additional CBT in adolescents with persistent and impairing ADHD symptoms after a short psychoeducational intervention and medical treatment.MethodsThe authors conducted a two-arm parallel randomized controlled trial in two child and adolescent mental health outpatient clinics in Norway. One hundred patients aged 14-18 years with a diagnosis of ADHD (66%) or subthreshold ADHD (34%) were randomized to either a 12-week group CBT program (N = 50) or a non-CBT control condition (N = 50). Assessments were made at admission to the clinic, two weeks before and two weeks after treatment. The primary outcomes were parent-, teacher- and self-ratings of ADHD symptoms (ADHD Rating Scale-IV), and the secondary outcomes were ratings of ADHD symptom severity, executive function, functional impairment, and emotional problems. Evaluators blinded to group allocation rated ADHD symptom severity with the Clinical Global Impression Scale for Severity (CGI-S) at baseline and post-treatment.ResultsAnalyses using mixed-effects models showed no difference between the treatment arms from baseline to post treatment in primary and secondary outcomes.ConclusionsContrary to our hypothesis, we found no incremental treatment effect on the part of a group CBT as follow-up to psychoeducation and pharmacological treatment on ADHD symptoms and accompanying impairments. Limitations with the CBT was the large number and low dosage of treatment components, causing restricted time for practice. Unlike evidence-based, individualized targeted CBTs with parent involvement, a group CBT directed solely at the adolescents with no parent involvement does not appear effective for treating ADHD.Trial registrationNCT02937142 , 18/10/2016.

Project description:BackgroundInsomnia is a prevalent sleep disorder associated with significant economic and personal burdens. Cognitive behavioural therapy for insomnia (CBTI) is considered the gold standard intervention for insomnia and its efficacy has been well demonstrated. However, the core treatment strategies of CBTI require significant behavioural change, which many individuals find challenging. As a result, although CBTI is efficacious, its effectiveness is reduced by modest levels of adherence in typical clinical settings. This is problematic as adherence is essential to attain desired treatment outcomes. Sleep is often a dyadic process, with approximately 60% of Australian adults sharing a bed. Hence, the present study aims to determine whether incorporating bed partners into treatment for insomnia increases treatment adherence and completion. The impact of adherence on symptoms of insomnia will also be examined.MethodsThis study is a mixed-effects randomised effectiveness trial of partner-assisted CBTI (PA-CBTI). It is an "effectiveness" (as opposed to "efficacy") trial, due to the focus on "real world" clinic-based clients and adherence/attrition as outcomes. Participants will include 120 clients with insomnia who are randomly assigned, in equal numbers, to PA-CBTI, traditional individual CBTI (i-CBTI), or partner-assisted sleep management therapy (PA-SMT; which serves as the control group). All interventions consist of seven weekly 1-h sessions. Treatment outcome is evaluated using clinician-rated treatment adherence, and diary-based adherence to stimulus control and sleep restriction. Clients and partners complete major assessments at pre- and post-treatment, and at 6-month follow-up. Secondary outcome variables include actigraphy, self-report measures related to sleep, comorbid psychopathology, and relationship functioning.DiscussionThis is the first randomised clinical trial to examine the impact of incorporating the bed partner in the treatment of insomnia. Results will provide new information about the role partners play in clients' insomnia presentation and treatment response, and better define the role of adherence in CBTI. This trial has the potential to optimise treatment outcomes for insomnia by improving adherence and reducing attrition. Results could have far-reaching impacts. Improvements in insomnia have been linked to improvements in mental and physical health and, given the high financial costs of insomnia, this study could have a positive economic impact.Trial registrationACTRN, ACTRN12616000586415 . Registered on 5 May 2016.

Project description:BackgroundAdolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adults and shows promise for adolescents. However, given the scale of the problem of adolescent SAD and the limited availability of psychological therapists in child and adolescent mental health services, there is a substantial gap in service provision. Delivering therapy via the Internet may provide part of the solution to this problem. An Internet version of adult Cognitive Therapy for SAD has been developed, with outcomes similar to face-to-face therapy. We have recently adapted this treatment for use with adolescents with SAD. Here, we describe a randomised controlled trial designed to test the efficacy of Internet Cognitive Therapy for adolescent SAD compared to waitlist.Methods/designForty adolescents aged 14-18?years with a diagnosis of SAD will be recruited via schools. Participants will be randomly allocated to Internet Cognitive Therapy or to waitlist. All participants will be assessed three times during the study-at baseline (pretreatment/wait), midtreatment/wait (week 8) and posttreatment/wait (week 15). Participants in the experimental arm will also complete weekly measures as part of the online program and they will be assessed at 3 and 6?months. Postwait, participants in the waitlist arm will be offered Internet Cognitive Therapy, and weekly and posttreatment data will also be collected for them. The trial aims to test whether Internet Cognitive Therapy is superior to waitlist in reducing social anxiety symptoms and in reducing the proportion of adolescents meeting criteria for SAD. Other outcomes of interest include depression and general anxiety symptoms. Acceptability of the online treatment will also be evaluated.DiscussionThis randomised controlled trial will provide preliminary evidence on whether this intervention, requiring relatively low levels of therapist input, is safe and clinically effective. If this is shown to be the case, Internet Cognitive Therapy for adolescents has the potential to provide a service to the large population of adolescents with untreated SAD.Trial registrationISRCTN Registry, ISRCTN15079139 . Version 1 registered on 06/02/2019.

Project description:Several randomised controlled trials (RCT) have demonstrated the superiority of transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care. To date, however, no RCTs have been conducted to compare TD-CBT to another active intervention in this setting. Our aim is to conduct a single-blind RCT to compare group TD-CBT plus TAU to progressive muscle relaxation (PMR) plus TAU in adults (age 18 to 65 years) with a suspected emotional disorder. We expect that TD-CBT + TAU will be more cost-effective than TAU + PMR, and that these gains will be maintained at the 12-month follow-up. Seven therapy sessions (1.5 hours each) will be offered over a 24-week period. The study will be carried out at four primary care centres in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be made at three time points: baseline, post-treatment, and at 12-months. The following variables will be evaluated: clinical symptoms (anxiety, depression, and/or somatic); functioning; quality of life (QoL); cognitive-emotional factors (rumination, worry, attentional and interpretative biases, emotion regulation and meta-cognitive beliefs); and satisfaction with treatment. Data on health service use, medications, and sick days will be obtained from electronic medical records. Primary outcome measures will include: incremental cost-effectiveness ratios (ICER) and incremental cost-utility ratios (ICURs). Secondary outcome measures will include: clinical symptoms, QoL, functioning, and treatment satisfaction. Bootstrap sampling will be used to assess uncertainty of the results. Secondary moderation and mediation analyses will be conducted. Two questionnaires will be administered at sessions 1, 4, and 7 to assess therapeutic alliance and group satisfaction. If this trial is successful, widespread application of this cost-effective treatment could greatly improve access to psychological treatment for emotional disorders in the context of increasing demand for mental healthcare in primary care. Trial registration: ClinicalTrials.gov: Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP). NCT05314920.

Project description:BackgroundA cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood.Methods/designThis article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, "ReCaPTure LiFe" will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15-25 years who have completed cancer treatment in the past 1-6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity.DiscussionThis article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life.Trial registrationACTRN12610000717055.

Project description:IntroductionThe traumatic death of a loved one, such as death due to a traffic accident, can precipitate persistent complex bereavement disorder (PCBD) and comorbid post-traumatic stress disorder (PTSD) and depression. Waitlist-controlled trials have shown that grief-specific cognitive-behavioural therapy (CBT) is an effective treatment for such mental health problems. This is the first study that will examine the effectiveness of online CBT (vs waitlist controls) in a sample exclusively comprised of people bereaved by a traumatic death. Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist. We further expect that reductions in symptom levels during treatment are associated with reductions of negative cognitions and avoidance behaviours and the experience of fewer accident-related stressors. Moreover, the effect of the quality of the therapeutic alliance on treatment effects and drop-out rates will be explored.Methods and analysisA two-arm (online CBT vs waiting list) open-label parallel randomised controlled trial will be conducted. Participants will complete questionnaires at pretreatment and 12 and 20 weeks after study enrolment. Eligible for participation are Dutch adults who lost a loved one at least 1 year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression. Multilevel modelling will be used.Ethics and disseminationEthics approval has been received by the Medical Ethics Review Board of the University Medical Center Groningen (METc UMCG: M20.252121). This study will provide new insights in the effectiveness of online CBT for traumatically bereaved people. If the treatment is demonstrated to be effective, it will be made publicly accessible. Findings will be disseminated among lay people (eg, through newsletters and media performances), our collaborators (eg, through presentations at support organisations), and clinicians and researchers (eg, through conference presentations and scientific journal articles).Trial registration numberNL7497.

Project description:IntroductionAnxiety disorders have a high lifetime prevalence, early-onset and long duration or chronicity. Exposure therapy is considered one of the most effective elements in cognitive behavioural therapy (CBT) for anxiety, but in vivo exposure can be challenging to access and control, and is sometimes rejected by patients because they consider it too aversive. Virtual reality allows flexible and controlled exposure to challenging situations in an immersive and protected environment.AimThe SoREAL-trial aims to investigate the effect of group cognitive behavioural therapy (CBT-in vivo) versus group CBT with virtual reality exposure (CBT-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups.Methods and analysisThe design is an investigator-initiated randomised, assessor-blinded, parallel-group and superiority-designed clinical trial. Three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centres of Copenhagen and North Sealand and the Northern Region of Denmark. All patients will be offered a manual-based 14-week cognitive behavioural group treatment programme, including eight sessions with exposure therapy. Therapy groups will be centrally randomised with concealed allocation sequence to either CBT-in virtuo or CBT-in vivo. Patients will be assessed at baseline, post-treatment and 1-year follow-up by treatment blinded researchers and research assistants. The primary outcome will be diagnosis-specific symptoms measured with the Liebowitz Social Anxiety Scale for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia for patients with agoraphobia. Secondary outcome measures will include depression symptoms, social functioning and patient satisfaction. Exploratory outcomes will be substance and alcohol use, working alliance and quality of life.Ethics and disseminationThe trial has been approved by the research ethics committee in the Capital Region of Denmark. All results, positive, negative as well as inconclusive, will be published as quickly as possible and still in concordance with Danish law on the protection of confidentially and personal information. Results will be presented at national and international scientific conferences. The trial has obtained approval by the Regional Ethics Committee of Zealand (H-6-2013-015) and the Danish Data Protection Agency (RHP-2014-009-02670). The trial is registered at ClinicalTrial.gov as NCT03845101. The patients will receive information on the trial both verbally and in written form. Written informed consent will be obtained from each patient before inclusion in the trial. The consent form will be scanned and stored in the database system and the physical copy will be destroyed. It is emphasised that participation in the trial is voluntary and that the patient can withdraw his or her consent at any time without consequences for further and continued treatment.Trial registration numberNCT03845101.

Dataset Information

Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial.

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Cognitive-behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial.

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