Comparing efficacy of cognitive behavioral therapy & cognitive behavioral therapy with metacognitive techniques on biological & psychological hyper-arousal in people with chronic insomnia disorder.

Evaluation efficacy of cognitive behavioral therapy and cognitive behavioral therapy with metacognitive techniques on hyper-arousal

Randomized clinical trial without control group, parallel group, single blind. Randomization will carry out by someone who will blinded about study goals.

After ending of recruitment of patients from two health centers and taking initial evaluation and checking out inclusive and exclusive criteria, patients will allocated randomly to two intervention groups. During receiving and after end of treatments, all patients will assess six times by evaluator. Randomizer will unaware of the study goal. Researchers and therapists will have no role in evaluation of study outcomes. Also, evaluator will unaware of who belong to which group and the study goal.

Inclusive criteria: Duration of insomnia disorder should be 3 months or more; Informed consent should be completed. Exclusive criteria: An untreated or undiagnosed psychiatric disorder and a condition or disorder; Comorbidity with schizophrenia, trauma brain injury, seizure and bipolar disorder, other sleep disorders; Using medications for treating of insomnia; Cognitive impairment that make impossible to follow treatment instructions; Use of substances and alcohol at least six months before the study; Having variable shift work.

Intervention group 1: Cognitive behavioral therapy include stimulus control therapy, sleep restriction therapy, sleep hygiene education, and cognitive therapy; Intervention group 2: Cognitive behavioral therapy with meta-cognitive techniques include stimulus control therapy, sleep restriction therapy, sleep hygiene education, detached mindfulness, and worry & rumination postponement.

Biological & psychological hyper-arousal

Simple randomization is used. In order to randomization, researchers were used sealed pocket. Someone who was not in charge of applying interventions and evaluating of outcomes and was unaware of the study goals, run randomization.

After randomization, someone who was in charge of randomization, call to all participants and asked they to refer to clinic in determined days. Participants does not received any information about who was belong to which group. In fact, all participants were unaware from who belong to which group till session five of treatment. In the session, patients received cognitive or metacognitive techniques. Therefore, nature of received therapy was specified. Researchers and therapists was aware from who does belong to which group but have not any role in evaluating of study outcomes. Evaluation of outcomes is done in center near the clinic. Evaluator was unaware from goal of the study and who belong to which group.

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