RUFUS - Group Rumination-focused CBT for Negative Symptoms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-37
SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

About this trial

Abstract - --

Introduction:

Psychosis spectrum disorders are characterized by both positive and negative symptoms, but whereas there is good effect of treatment on positive symptoms, there is still a scarcity of effective interventions aimed at reducing negative symptoms. Rumination has been proposed as an important and fundamental factor in the development and maintenance of symptoms across psychiatric diagnoses, and there is a need to develop effective interventions targeting rumination behaviors and negative symptoms in patients with psychotic disorders. The aim of the current study is to investigate the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (RFCBT) in the treatment of young people with psychosis spectrum disorders as well as investigating potential indications of treatment efficacy.

Methods and analysis: The study is a mixed-method clinical randomized controlled pilot trial with a target sample of 60 patients, who are randomized to either receive 13 weeks of group CFCBT or 13 weeks of treatment as usual (TAU). All patients are examined at the start of the project and at the 13-week follow-up. The researcher will compare changes in outcomes from baseline to posttreatment between group CFCBT and TAU. In addition, qualitative analyzes are carried out to explore feasibility and acceptability and to uncover the patients' experience of receiving the intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with a psychosis spectrum disorder (ICD-10 F2x)

At least 8 months left of their OPUS treatment

The presence of rumination behavior as assessed by a score of minimum 30 on the Perseverative Thinking Questionnaire (PTQ)

Danish-speaking

Disqualifiers

Substance abuse or positive symptoms that make participation in therapy difficult

Severe suicidal thoughts/behavior

Lacks capacity to consent

Mild, moderate, or severe intellectual disability (IQ ˂ 70)

Trial design

Design model

Parallel

Treatments tested in this trial

  • group rumination focused cognitive behavioural therapy

    Other intervention

    Psychotherapy

  • Treatment as usual

    Other intervention

    opus treatment

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: rumination-focused cognitive behavioural group therapyExperimental treatment 1 intervention
Group B: Treatment as usualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the Brief Negative Symptoms Scale (BNSS)

Assessment of negative symptoms on a scale from 0-78

Time frame
up to 20 weeks

Secondary outcomes

1

Perseverative Thinking Questionnaire (PTQ)

Measuring frequency of rumination. Resulting in a total score of 0-60.

Time frame
up to 20 weeks
2

Ruminative Response Scale (RRS)

Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.

Time frame
up to 20 weeks
3

Social Functioning Scale (SFS)

Measuring level of functioning on a scale from of 0-228

Time frame
up to 20 weeks
4

Scale for the assessment of positive symptoms (SAPS)

Measuring presence of positive symptoms on a scale from 0-170

Time frame
up to 20 weeks

Other outcomes

Sponsors and contacts

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