iACT for PTSD and Chronic Pain : a Development Pilot Series
Condition: PTSD; Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effect of Internet-delivered Acceptance
      and commitment therapy for PTSD and comorbid chronic pain. First, a pilot study (no
      randomization; N=10) will be conducted to test the intervention and assessment procedures.
      This will be followed by a randomized controlled trial with waitlist control. The
      participants will go through an active internet-based ACT treatment focused on education
      about PTSD, value-based exposure for the traumatic memory and avoided situations, and
      behavior change through exercises targeting the processes mindfulness, cognitive defusion and
      acceptance. The treatment is delivered on a safe internet platform. Participants have planned
      telephone contact with their assigned psychologist 3 times during the program and can also
      contact their psychologist via a message system in the platform and expect answer within 48
      hours.
    

Detailed description: 
      Objective: The primary aim of this study is to investigate the effect of Internet-delivered
      Acceptance and commitment therapy (iACT) for PTSD and comorbid chronic pain.

      Sample size: 10 participants.

      Trial design: All participants are offered treatment. Participants are recruited from the
      Pain Rehabilitation Unit at Skåne University Hospital. The unit is a government supported,
      regional specialist center focused on assessment and treatment of chronic pain and related
      disability.

      Assessments: Baseline and post treatment (2 weeks after treatment) assessments will be
      conducted by an assessor who is trained to administer the study measures. Self-report
      measures will also collected at this time, post treatment (2 weeks after treatment) as well
      as during a 3-month follow up.

      Assessment includes:

      Pre-and post assessment: Assessors will collect demographic information, self-report
      measures, and trauma history. During the pre- and post-assessment the Clinician-Administered
      PTSD Scale for DSM-5 will be administered to establish PTSD whether participants met the
      DSM-5 criteria for PTSD.

      During the pre-assessment the Mini International Neuropsychiatric Interview 5.0 (MINI) will
      be administered to detect the presence of other comorbid disorders and assess inclusion
      criteria and rule out exclusion criteria.

      Post-treatment exit interview: At the post-assessment, the assigned assessor will ask
      participants about their satisfaction with and experience of the program, what they found
      helpful or unhelpful and suggestions for future improvements.

      During treatment: During treatment the treatment credibility scale will be administered to
      assess the patients' perceptions of how credible the treatment is following the introduction
      of the treatment rationale and the main treatment components (included in the internet
      program).

      Safety parameters: As a mean to monitor safety and progress participants complete two
      self-report measures within the program (PTSD Checklist for DSM-5 [PCL-5] and Hospital
      anxiety and depression scale [HADS] twice during the program and the therapist can follow
      these scores. In addition, participants can report any adverse events during treatment, at
      post treatment and follow-up assessment.

      Data collection: Self-report measures will be mailed to participants

      Main statistical analysis: Between-group estimates on outcome will be conducted using
      repeated measurements. The analyses will be conducted using intention to treat principles and
      post hoc comparisons.
    

Intervention name(s): Internet-delivered ACT for PTSD and chronic pain
Intervention type(s): Behavioral
Intervention description(s): The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Chronic pain