Implementation of the Hybrid Treatment in Clinical Care. A SCED.

NCT05082922 | Unknown

• 1 other identifier: HYBRID2.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. One important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. An important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. Specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. The aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. The treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.

Conditions

Emotional Problem; Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Generalised Anxiety Disorder (GAD-7) change

  change in self rated anxiety. Scale range 0-27 (higher values worse outcome)

  repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.

• Patient Health Questionnaire (PHQ-9) change

  change in self rated depression. Scale range 0-27 (higher values worse outcome)

  repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.

• Pain change

  change in pain intensity (scale 0-6) and interference. Scale range 0-6 (higher values worse outcome)

  repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.

• Pain coping change

  change in pain worry (scale 0-6) and avoidance (scale range 0-8) (higher values worse outcome)

  repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.

• Symptom Catastrophizing Scale (SCS) change

  Change in catastrophic interpretation of symptoms. Scale range 0-14 (higher values worse outcome)

  Baseline, 5 months and 11 months as well as repeated weekly through phase A (randomly assigned to be 4, 5 or 6 weeks) and treatment phase B (14 to 16 weeks). Total time frame of assessment is 20 weeks.

Secondary Outcomes (8)

• Multidimensional Pain Inventory (MPI) change

  Baseline, 5 months and 11 months

• Montgomery Åsberg Depression Rating Scale (MADRS) change

  Baseline, 5 months and 11 months

• Difficulties in Emotion Regulation Scale (DERS-16) change

  Baseline, 5 months and 11 months

• Psychological Inflexibility in Pain Scale (PIPS) change

  Baseline, 5 months and 11 months

• Work limitation questionnaire-16 change

  Baseline, 5 months and 11 months

Other Outcomes (4)

• adverse effects

  5 months

• Treatment satisfaction questionnaire

  5 months

• sick leave and medication use

  Baseline, 5 months and 11 months

Study Arms (2)

No treatment waiting period

NO INTERVENTION

Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period.

Hybrid treatment

EXPERIMENTAL

Hybrid treatment. Weekly measurements are collected throughout treatment.

Behavioral: Hybrid treatment

Interventions

Hybrid treatment BEHAVIORAL

Transdiagnostic emotion-focused treatment provided by a psychologist with, when needed, support of a medical doctor (ensuring adherence to medical guidelines) and a physiotherapist (providing assessment and treatment support in exposure for physical activities). Depending on the length of the waiting period (randomly assigned to be either 4, 5 or 6 weeks), the treatment period varies between 14-16 weeks and contains 10-15 sessions.

Hybrid treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 11 points on the anxiety or depression subscale, Hospital Anxiety and Depression scale
• somatic health problems (pain \> 3 months) with functional impairment (\>3 on question 2 of the Multidimensional Pain Inventory, MPI, OR \> 20 points on question 21-24 of the Örebro Musculoskeletal Pain Questionnaire, ÖMPQ)

You may not qualify if:

• severe psychiatric problems requiring immediate other treatment
• current psychological treatment
• recently started psychopharmacological treatment for anxiety or depression (\<3 months prior to planned treatment)
• insufficient mastery of the Swedish language

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Center for Health and Medical Psychology

Örebro, 70182, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employs a sequential single-case experimental AB design with randomized waiting period lengths (4, 5 or 6 weeks). Included in the design is also standardized pre-post and follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, practitioners and clinical managers, detailing how the treatment and its implementation are experienced.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 19, 2021
• Study Start: October 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

SE (1)