A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol for a randomized controlled trial.

BACKGROUND: Suffering linked to previous interpersonal trauma is common among patients in mental health care. Diagnostic labels may vary, but the clinical picture is often characterized by long-lasting and complex psychological and somatic symptoms, subjective distress and reduced quality of health and life. A substantial proportion of patients do not recover after individual treatment in ordinary specialized mental healthcare settings, despite the proven usefulness of individual trauma-specific treatments. The therapeutic factors that arise in group settings, such as normalization, shame reduction and corrective relational experiences, may be particularly useful for trauma survivors. However, evidence in support of group treatment for trauma survivors is scarce. This study aims to test whether combining a novel group intervention to individual treatment is superior to conventional individual out-patient treatment in an ordinary community mental health hospital. METHODS: In a single-site, non-blinded, randomized controlled trial (RCT), the effect of a combined group-based stabilization and skill-training (SST) intervention added to individual treatment will be compared to conventional treatment (treatment as usual, TAU) alone. Participants (N = 160) with ongoing and long-lasting reactions related to known adverse life events from the past will be recruited among patients at general outpatient clinics in a community mental health centre at St. Olav's University Hospital, Trondheim, Norway. Following baseline assessment and randomization, participants will complete follow-up measures at 4, 8, 13 and 19 months post-baseline. The primary outcome is personal recovery (The questionnaire about the process of recovery , QPR). Secondary outcomes include (1) self-reported symptoms of posttraumatic stress, general mental and somatic health symptoms, well-being, functional impairment and client satisfaction, (2) immunological and endocrine response measured in blood samples and (3) national registry data on occupational status, use of mental health services and pharmacological treatment. Additionally, mechanisms of change via posttraumatic cognitions will be examined. DISCUSSION: The addition of a group-based intervention to individual treatment for trauma survivors might prove to be an efficient way to meet the need of long-lasting high-intensity treatment in a large group of patients in mental health care, thereby reducing their suffering and increasing their psychosocial functioning. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03887559. Registered on 25 March 2019.

Psychoeducational groups versus waitlist in treatment of attention-deficit hyperactivity/impulsivity disorder (ADHD) in adults: a protocol for a pilot randomized waitlist-controlled multicenter trial.

BACKGROUND: Psychoeducation is included in the Norwegian national guidelines for treatment of adult ADHD. Despite some promising results for the treatment of other conditions and ADHD, little is known about the efficacy of such interventions. This paper presents a protocol for a pilot randomized controlled trial featuring a psychoeducational group program for patients with ADHD. The main objective of this pilot trial is to investigate adherence, feasibility, and preliminary efficacy of a ten-session psychoeducational group designed to address specific challenges faced by adults diagnosed with ADHD. METHODS: This pilot study will evaluate patient satisfaction and preliminary efficacy of a psychoeducational group treatment using a randomized waitlist-controlled trial at two different outpatient clinics in mid-Norway. All participants will receive treatment as usual, concomitant with the intervention and waitlist period. Client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL), symptoms of ADHD (SCL-9; ASRS), and work participation will be assessed at the time of recruitment prior to randomization (T0), pre-intervention (T1), post-intervention (T2), and at 10 weeks follow-up (T3). Recruitment and dropout rates along with treatment adherence will also be evaluated. DISCUSSION: This study offers valuable insight into the preliminary efficacy of educational programs implemented in outpatient clinics. The aim of the trial is to evaluate adherence, feasibility, patient satisfaction, and the preliminary efficacy of a psychoeducational group intervention for patients with adult ADHD and provide further insight into the design and construction of a large-scale trial. The results also offer preliminary empirical evidence to inform the development of larger and more complex studies. TRIAL REGISTRATION: NCT03337425, Registered 9 November 2017.

Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study.

OBJECTIVE: To investigate the effect of having a contract for self-referral to inpatient treatment (SRIT) in patients with severe mental disorders. METHODS: A randomized controlled trial with 53 adult patients; 26 participants received a SRIT contract, which they could use to refer themselves into a Community Mental Health Centre up to five days for each referral without contacting a doctor in advance. Outcomes were assessed after 12 months with the self-report questionnaires Patient Activation Measure (PAM-13), Recovery Assessment Scale (RAS), and the Behavior and Symptom Identification Scale (BASIS-32) and analyzed using linear mixed and regression models. RESULTS: There was no significant effect on PAM-13 (estimated mean difference (emd) -0.41, 95% CI (CI):-7.49-6.67), nor on the RAS (emd 0.02, CI:-0.27-0.31) or BASIS-32 (0.09, CI:-0.28-0.45). An exploratory post hoc analysis showed effect of SRIT in those with low PAM below ≤47 (p=0.049). CONCLUSION: There were no group differences after 12 months, but both groups maintained their baseline levels. PRACTICE IMPLICATIONS: SRIT contracts can be recommended as it supports the rights to self-determination, promote user participation in decision-making in own treatment without any indication of adverse effects.

Short-term effects of a peer co-led educational programme delivered before mental health treatment: A randomised controlled trial.

OBJECTIVE: To investigate the 1-month effects of an educational programme co-led by peers delivered before treatment on treatment preferences, self-management knowledge and motivation in comparison to usual care. METHODS: Adults referred to a community mental health centre were randomised to either a control group (n=48) or a peer co-led educational programme (intervention group, n=45). The programme consisted of an 8-hour group education session followed by an individual pretreatment planning session. The main topics of the educational programme were treatment options, patients' rights, self-management, the importance of patient activation and participation. RESULTS: At 1-month follow-up, a significantly larger proportion of the patients in the intervention group knew which type of treatment they preferred (76.7% vs. 32.5%, p<0.001). The intervention group had significantly higher self-management knowledge (p<0.001). There was no effect on treatment motivation (p=0.543). CONCLUSION: At 1-month following the delivery of a pretreatment educational programme, we found that participants' knowledge of treatment preferences and self-management had improved. PRACTICE IMPLICATIONS: Educational interventions co-led by peers can optimise the process of informing and educating outpatients, thereby helping patients to clarify their treatment preferences.