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

Örebro University, Sweden50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Emotional Problem Chronic Pain

Hybrid treatmentBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \> 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) Exclusion Criteria: * 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

Locations (1)

Center for Health and Medical Psychology

Örebro, Sweden

Outcomes

Primary Outcomes

Generalised Anxiety Disorder (GAD-7) change

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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Multidimensional Pain Inventory (MPI) change

change in pain intensity and interference. Subscale pain intensity range 0-12, subscale pain interference range 0-66 (for both sub scales higher values worse outcome)