The goal of this randomized pilot feasibility trial is to assess the feasibility and further develop a single-session digital mental health intervention for patients on waiting lists for psychological treatment. The main aims are: 1. To evaluate the feasibility and acceptability of the study procedures and the digital single-session intervention. 2. To gather quantitative and qualitative feedback on the intervention to inform further development. 3. To collect preliminary data to refine the analysis plan for a main trial. Researchers will compare two different versions of the intervention (one longer and one shorter) with two control conditions (one active and one passive) to see if the study is feasible. Participants will be randomized to one of the four conditions, do a short digital mental health intervention and fill out 4 questionnaires across a 5 week period.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Recruitement rates through the study period as assessed by number of participants providing informed consent, and the time it takes to finish recruitment
Timeframe: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of participants invited to participate in the study throughout the study period and the frequency of invitations
Timeframe: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of participants screened for eligibility throughout the study period.
Timeframe: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of participants in each randomization arm.
Timeframe: From Day 1 (recruitment initiation) until recruitment completion (recruitment target met or earlier termination). Expected duration: 2 months.
Number of responses to each questionnaire and intervention representing missing data patterns and attrition across arms and measurement points
Timeframe: From Day 1 (recruitment initiation) until study completion. Expected duration: 3.5 months.
Number of participants who want to pull out of study or get data deleted throughout the study period
Timeframe: From Day 1 (recruitment initiation) until study completion. Expected duration: 3.5 months.
Acceptability of interventions and active control conditions as measured by the PFS and TCQ.
Timeframe: Assessed immediately after doing the intervention or the active control condition, which is on day 1-7 of the study period of 5 weeks. The passive control arm will not get these questions.
Time used to finish questionnaires and interventions
Timeframe: On each questionnaire and intervention, totaling 6 measurement times.
Timing of answers to questionnaires and completion of the study
Timeframe: From the start of invitation to the end of the study at 6 weeks.
Belief about positive or negative interaction with planned treatment
Timeframe: Asked at each measurement time after the baseline. This includes right after the intervention, at two week follow up and at 5 week follow up.